An institutional review board-based clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2013-01-01

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

The research program coordinator: an example of effective management.

PubMed

Merry, Lisa; Gagnon, Anita J; Thomas, Julia

2010-01-01

Careers in clinical research management are increasingly common. Despite nurses' important role in clinical research, their status as research professionals is underrecognized. In this article, we describe the role of a "program coordinator" (PC) in the context of a complex research program on migration and reproductive health. The PC role expands beyond the usual role of a research coordinator because he or she is involved in all aspects of the program of research and his or her responsibilities include research, education, clinical, and administration components. He or she ensures optimal organization and continuity across several studies and ensures ethical and scientific standards are applied for each individual study. His or her clinical knowledge assures data are accurate and subjects are safe. In addition, he or she assists with applying for funding, the maintenance of research partnerships, and dissemination of research findings; he or she supports students' learning and completes all regulatory aspects related to the program of research. Key to the PC role is relationship building and the application of Good Clinical Practice principles. The advanced role of a PC also warrants opportunities for professional development and a competitive salary. A PC is an effective approach for research management and a natural role for professional nurse. Copyright 2010 Elsevier Inc. All rights reserved.

Bridging the Gap: Supporting Translational Research Careers Through an Integrated Research Track Within Residency Training

PubMed Central

Arbuckle, Melissa R.; Gordon, Joshua A.; Pincus, Harold A.; Oquendo, Maria A.

2013-01-01

In the setting of traditional residency training programs, physician–scientists are often limited in their ability to pursue research training goals while meeting clinical training requirements. This creates a gap in research training at a critical developmental stage. In response, Columbia University Medical Center’s Department of Psychiatry, in partnership with the New York State Psychiatric Institute, has created a formal Research Track Program (RTP) for psychiatry residents so that interested individuals can maintain their attention on research training during formative residency years. Clinical and research training are integrated through core clinical rotations on research units. With protected research time and clear developmental milestones for each year of training, the RTP allows research track residents to meet both clinical and research training goals while maintaining a healthy work–life balance. In coordination with existing postdoctoral research fellowship programs, research track residents can effectively jump-start fellowship training with advanced course work and consistent, continuous mentorship bridging residency and fellowship years. A key element of the program is its provision of core training in research literacy and extensive research opportunities for all residents, stimulating research interest across the whole residency program. Supported by the National Institutes of Health and a private foundation, this RTP capitalizes on a unique academic–private partnership to address many of the challenges facing physician–scientists. By integrating clinical and research exposures and offering protected research time, careful mentoring, and financial resources, the program aims to further the development of those most poised to establish careers in translational research. PMID:23619070

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

PubMed

Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-05-01

Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

PubMed

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

2018-03-01

The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

Evaluation of Clinical Research Training Programs Using the Clinical Research Appraisal Inventory

PubMed Central

Lipira, Lauren; Jeffe, Donna B.; Krauss, Melissa; Garbutt, Jane; Piccirillo, Jay; Evanoff, Bradley; Fraser, Victoria

2010-01-01

Abstract The purpose of this study was to measure change in clinical research self‐efficacy after participating in KL2, postdoctoral and predoctoral clinical research training programs at Washington University School of Medicine. We surveyed program participants using a 76‐item version of the Clinical Research Appraisal Inventory (CRAI). Principal components analysis (PCA) examined the CRAI’s underlying factor structure; Cronbach alpha measured the internal consistency of items on each subscale and the overall CRAI. CRAI score changes from baseline to 1‐year follow‐up were assessed using repeated‐measures analysis of variance. All 29 KL2, 47 postdoctoral, and 31 TL1 scholars enrolled 2006–2009 (mean age 31.6 years, range 22–44; 59.6% female; 65.4% white) completed baseline surveys. Of these participants, 22 KL2, 17 postdoctoral, and 21 TL1 scholars completed the 1‐year follow‐up assessment. PCA resulted in a seven‐factor solution with 69 items (alphas > 0.849 for each subscale and 69‐item CRAI). Significant improvements at 1‐year follow‐up were observed across all programs for Study Design/Data Analysis (p= .016), Interpreting/Reporting/Presenting (p= .034), and overall CRAI (p= .050). Differences between programs were observed for all but one subscale (each p < .05). Clinical research self‐efficacy increased 1 year after clinical research training. Whether this short‐term outcome correlates with long‐term clinical research productivity, requires further study. Clin Trans Sci 2010; Volume 3: 243–248. PMID:21442017

The summer institute in clinical dental research methods: still going and growing after twenty years.

PubMed

Derouen, Timothy A; Wiesenbach, Carol

2012-11-01

The first Summer Institute in Clinical Dental Research Methods, a faculty development program at the University of Washington, was offered in the summer of 1992 for sixteen participants. The primary objective of the program was to give clinical faculty members in dentistry an introduction to and an understanding of the fundamental principles and methods used in good clinical research. In the twentieth offering of the institute in 2011, there were thirty-five participants, and over the twenty institutes, there has been a cumulative total of 463 participants who have come from thirty U.S. states as well as forty-three countries outside the United States. The curriculum has expanded from the initial offering of biostatistics, clinical epidemiology, behavioral research methods, and ethics in clinical research to now include clinical trials, grantsmanship, data analysis, an elective in molecular biology, and a team project that provides participants with hands-on experience in research proposal development as members of an interdisciplinary team. Enrollment has doubled since the first year, yet exit evaluations of the program content have remained consistently high (rated as very good to excellent). One of the indicators of program quality is that at least 50 percent of recent participants indicated that they attended because the program was recommended by colleagues who had attended. There seems to be an ever-increasing pool of dental faculty members who are eager to learn more about clinical research methodology through the institute despite the intensive demands of full-time participation in a six-week program.

Kathleen Igo | Frederick National Laboratory for Cancer Research

Cancer.gov

Directorate: Clinical Research Program Department or lab: Clinical Monitoring Research Program (CMRP) How many years have you worked at the Frederick National Laboratory? I am in my 7th year of employment.

Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

PubMed Central

Hurley, Patricia; Woo, Kaitlin M.; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-01-01

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. PMID:27006354

Supplementing Resident Research Funding Through a Partnership With Local Industry.

PubMed

Skube, Steven J; Arsoniadis, Elliot G; Jahansouz, Cyrus; Novitsky, Sherri; Chipman, Jeffrey G

2018-01-17

To develop a model for the supplementation of resident research funding through a resident-hosted clinical immersion with local industry. Designated research residents hosted multiple groups of engineers and business professionals from local industry in general surgery-focused clinical immersion weeks. The participants in these week-long programs are educated about general surgery and brought to the operating room to observe a variety of surgeries. This study was performed at the University of Minnesota, in Minneapolis, Minnesota, at a tertiary medical center. Ten designated research residents hosted general surgery immersion programs. Fifty-seven engineers and business professionals from 5 different local biomedical firms have participated in this program. General surgery research residents (in collaboration with the University of Minnesota's Institute for Engineering in Medicine) have hosted 9 clinical immersion programs since starting the collaborative in 2015. Immersion participant response to the experiences was very positive. Two full-time resident research positions can be funded annually through participation in this program. With decreasing funding available for surgical research, particularly resident research, innovative ways to fund resident research are needed. The general surgery clinical immersion program at the University of Minnesota has proven its value as a supplement for resident research funding and may be a sustainable model for the future. Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic

PubMed Central

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B.

2016-01-01

Background: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. Objectives: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. Study Design/Methods: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. Results: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. Conclusions: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies. PMID:29444602

Leading Change and Advancing Health by Enhancing Nurses' and Midwives' Knowledge, Ability and Confidence to Conduct Research through a Clinical Scholar Program in Western Australia

PubMed Central

Chapman, Rose; Duggan, Ravani; Combs, Shane

2011-01-01

This paper reports on an evaluation of a Clinical Scholar Program initiated at a hospital in Western Australia. The aim of the program was to build the capacity of nurses and midwives to conduct research and evidence-based practice within the hospital. The program was based on a previous program and consisted of six teaching days and four hours per month release for proposal preparation. At the end of the program participants were asked to complete a short anonymous questionnaire. The answers were analysed using standard processes of qualitative analysis. Themes emerging from the data included program strengths, individual gains, ability to conduct research, and areas for improvement. The findings highlighted that, while the participants considered that they were more knowledgeable and confident to conduct research, they still required support. The Clinical Scholar Program has provided a way to increase the capacity of clinicians to participate in research activities. PMID:22111024

Leading Change and Advancing Health by Enhancing Nurses' and Midwives' Knowledge, Ability and Confidence to Conduct Research through a Clinical Scholar Program in Western Australia.

PubMed

Chapman, Rose; Duggan, Ravani; Combs, Shane

2011-01-01

This paper reports on an evaluation of a Clinical Scholar Program initiated at a hospital in Western Australia. The aim of the program was to build the capacity of nurses and midwives to conduct research and evidence-based practice within the hospital. The program was based on a previous program and consisted of six teaching days and four hours per month release for proposal preparation. At the end of the program participants were asked to complete a short anonymous questionnaire. The answers were analysed using standard processes of qualitative analysis. Themes emerging from the data included program strengths, individual gains, ability to conduct research, and areas for improvement. The findings highlighted that, while the participants considered that they were more knowledgeable and confident to conduct research, they still required support. The Clinical Scholar Program has provided a way to increase the capacity of clinicians to participate in research activities.

Leading by Success: Impact of a Clinical & Translational Research Infrastructure Program to Address Health Inequities

PubMed Central

Shiramizu, Bruce; Shambaugh, Vicki; Petrovich, Helen; Seto, Todd B.; Ho, Tammy; Mokuau, Noreen; Hedges, Jerris R.

2016-01-01

Building research infrastructure capacity to address clinical and translational gaps has been a focus of funding agencies and foundations. Clinical and Translational Sciences Awards, Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) and the Institutional Development Award Infrastructure for Clinical and Translational Research funded by United States (US) government to fund clinical translational research programs have existed for over a decade to address racial and ethnic health disparities across the US. While the impact on the nation’s health can’t be made in a short period, assessment of a program’s impact could be a litmus test to gauge its effectiveness at the institution and communities. We report the success of a Pilot Project Program in the University of Hawaii RCTR Award in advancing careers of emerging investigators and community collaborators. Our findings demonstrated that the investment has a far-reaching impact on engagement with community-based research collaborators, career advancement of health disparities investigators, and favorable impacts on health policy. PMID:27797013

The Quantitative Evaluation of the Clinical and Translational Science Awards (CTSA) Program Based on Science Mapping and Scientometric Analysis

PubMed Central

Zhang, Yin; Wang, Lei

2013-01-01

Abstract The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. PMID:24330689

The quantitative evaluation of the Clinical and Translational Science Awards (CTSA) program based on science mapping and scientometric analysis.

PubMed

Zhang, Yin; Wang, Lei; Diao, Tianxi

2013-12-01

The Clinical and Translational Science Awards (CTSA) program is one of the most important initiatives in translational medical funding. The quantitative evaluation of the efficiency and performance of the CTSA program has a significant referential meaning for the decision making of global translational medical funding. Using science mapping and scientometric analytic tools, this study quantitatively analyzed the scientific articles funded by the CTSA program. The results of the study showed that the quantitative productivities of the CTSA program had a stable increase since 2008. In addition, the emerging trends of the research funded by the CTSA program covered clinical and basic medical research fields. The academic benefits from the CTSA program were assisting its members to build a robust academic home for the Clinical and Translational Science and to attract other financial support. This study provided a quantitative evaluation of the CTSA program based on science mapping and scientometric analysis. Further research is required to compare and optimize other quantitative methods and to integrate various research results. © 2013 Wiley Periodicals, Inc.

Hunner's Ulcers

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

Bladder Retraining

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

Establishing a successful clinical research program.

PubMed

Scoglio, Daniele; Fichera, Alessandro

2014-06-01

Clinical research (CR) is a natural corollary to clinical surgery. It gives an investigator the opportunity to critically review their results and develop new strategies. This article covers the critical factors and the important components of a successful CR program. The first and most important step is to build a dedicated research team to overcome time constraints and enable a surgical practice to make CR a priority. With the research team in place, the next step is to create a program on the basis of an original idea and new clinical hypotheses. This often comes from personal experience supported by a review of the available evidence. Randomized controlled (clinical) trials are the most stringent way of determining whether a cause-effect relationship exists between the intervention and the outcome. In the proper setting, translational research may offer additional avenues allowing clinical application of basic science discoveries.

77 FR 10455 - National Institutes of Health Loan Repayment Programs

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Repayment Program for Research with Respect to Acquired Immune Deficiency Syndrome (or AIDS Research LRP); Loan Repayment Program for General Research (or General Research LRP), which includes a program for the... Researchers from Disadvantaged Backgrounds (or Clinical Research LRP for Individuals from Disadvantaged...

Men and IC

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

IC Associated Conditions

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

General IC Symptoms

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

Children and IC

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

78 FR 8153 - National Institutes of Health

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

..., and clinical research to improve the benefits of transfusion while reducing its risks. The conduct of... programs have proven to be the premier research programs in blood collection and transfusion safety in the... research network has realized over the years while being responsive to changing research and clinical needs...

Development and Progression of a Model: Prospective Research Compliance Monitoring

ERIC Educational Resources Information Center

Fedor, Carol; Ferrazzano Yaussy, Cristina; Cola, Philip A.

2008-01-01

Recent trends in Human Research Protection Programs (HRPPs) have contributed to the rising emphasis on prospective monitoring of clinical research and education programs. Therefore, internal efforts and resources to monitor investigator compliance and site performance have become an important focus in the conduct of clinical research. Once the…

Needs assessment for collaborative network in pediatric clinical research and education.

PubMed

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, <30% of the hospitals had a data manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P < 0.01). The number of education programs was significantly correlated with the number of original articles and case reports in English (r = 0.788), and the number of publications in Japanese (r = 0.648). All hospitals recognized the need for a leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

Interstitial Cystitis and Diet

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

IC Treatment: Surgical Procedures

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

IC: Frequently Asked Questions

MedlinePlus

... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ... Epidemiology (RICE) Study Boston Area Community Health (BACH) Survey ICA Pilot Research Program Funding Opportunities Clinical Trial ...

Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

PubMed Central

Wilson, Lynda Law; Rice, Marti; Jones, Carolynn T.; Joiner, Cynthia; LaBorde, Jennifer; McCall, Kimberly; Jester, Penelope M; Carter, Sheree C.; Boone, Chrissy; Onwuzuligbo, Uzoma; Koneru, Alaya

2013-01-01

Introduction Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This paper describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. Methods A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included four required and one optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants’ capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. Results Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic internet access. Participants offered capacity building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. Findings Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials. PMID:23512562

A Summer Research Training Program to Foster PharmD Students' Interest in Research

PubMed Central

Moore, Mariellen J.; Shin, Jaekyu; Frye, Reginald F.

2008-01-01

Objectives To establish and assess the effectiveness of a 10-week summer research program on increasing doctor of pharmacy (PharmD) students' interest in research, particularly as it related to future career choices. Design Survey instruments were sent to 25 participants who had completed the research program in the summer of 2004, 2005, or 2006 to assess their satisfaction with the program and its influence on their career choices after graduation. Assessment Respondents reported a high degree of satisfaction with the program, indicating that the program allowed them to determine their suitability for a career in research, and 55% reported their intention to pursue additional research training. Conclusion A brief introduction to the clinical research environment helped pharmacy students understand the clinical sciences and careers in research. The introduction increased the likelihood of students pursuing a research career path after obtaining their PharmD degree. PMID:18483591

Interventions to support and develop clinician-researcher leadership in one health district.

PubMed

Fry, Margaret; Dombkins, Anthony

2017-07-10

Purpose Clinical leadership, researcher capacity and a culture of clinical inquiry are needed in the clinical workforce. The purpose of this paper is to report on a program which was used to develop and support clinicians to explore practice, implement innovation, translate evidence and build researcher capacity. Design/methodology/approach This pragmatic paper presents a case study of a nursing and midwifery clinician-researcher development program. The multi-site, multi-modal program focused on education, mentoring and support, communication networks, and clinician-university partnerships strategies to build workforce capacity and leadership. Findings Over 2,000 staff have been involved in the program representing a range of health disciplines. The study day program has been delivered to 500 participants with master classes having over 1,500 attendees. The research mentor program has demonstrated that participants increased their confidence for research leadership roles and are pursuing research and quality assurance projects. Communication strategies improved the visibility of nursing and midwifery. Research limitations/implications This case study was conducted in one health district, which may not have relevance to other geographical areas. The small numbers involved in the research mentor program need to be considered when reviewing the findings. Practical implications The program has been a catalyst for developing a research culture, clinical leadership and research networks that strengthen workforce capacity. Building researcher skills in the workforce will better support quality healthcare and the examination of everyday practice. Social implications Building a culture of healthcare that is based on inquiry and evidence-based practice will lead to more appropriate and consistent healthcare delivery. Consumers have the right to expect health clinicians will challenge everyday practice and have the skills and capability to translate or generate best evidence to underpin professional and service delivery. Originality/value This paper provides strategies for building workforce researcher capacity and capability. The program provides opportunity for building research networks and role modeling the value and importance of research to practice and quality improvement.

Emergency Medicine Resources within the Clinical Translational Science Institutes: A Cross-Sectional Study

PubMed Central

Meurer, William J.; Quinn, James; Lindsell, Christopher; Schneider, Sandra; Newgard, Craig D.

2016-01-01

Background The Clinical and Translational Science Award (CTSA) program aims to strengthen and support translational research by accelerating the process of translating laboratory discoveries into treatments for patients, training a new generation of clinical and translational researchers, and engaging communities in clinical research efforts. Yet, little is known about how emergency care researchers have interacted with and utilized the resources of academic institutions with CTSAs. Objective The purpose of this survey was to describe how emergency care researchers use local CTSA resources, to ascertain what proportion of CTSA consortium members have active emergency care research programs, and to solicit participation in a national CTSA-associated emergency care translational research network. Methods Survey of all emergency departments affiliated with a CTSA. Results Of the 65 CTSA consortium members, three had no emergency care research program and we obtained responses from 46 of the remaining 62 (74% response rate). The interactions with and resources used by emergency care researchers varied widely. Methodology and biostatistics support was most frequently accessed (77%), followed closely by education and training programs (60%). Several emergency care research programs (76%) had submitted for funding through CTSAs, with 71% receiving awards. Most CTSA consortium members had an active emergency care research infrastructure: 21 (46%) had 24/7 availability to recruit and screen for research, 21 (46%) had less than 24/7 research recruitment. A number of emergency care research programs participated in NIH research networks with the Neurological Emergencies Treatment Trials network most highly represented with 23 (59%) sites. Most emergency care research programs (96%) were interested in participating in a CTSA-based emergency care translational research network. Conclusions Despite little initial involvement in development of the CTSA program, there has been moderate interaction between CTSAs and emergency care. There is considerable interest in participating in a CTSA consortium based emergency care translational research network. PMID:26826059

Prevalence and Cost of Full-Time Research Fellowships During General Surgery Residency – A National Survey

PubMed Central

Robertson, Charles M.; Klingensmith, Mary E.; Coopersmith, Craig M.

2009-01-01

Structured Abstract Objective To quantify the prevalence, outcomes, and cost of surgical resident research. Summary Background Data General surgery is unique among graduate medical education programs because a large percentage of residents interrupt their clinical training to spend 1-3 years performing full-time research. No comprehensive data exists on the scope of this practice. Methods Survey sent to all 239 program directors of general surgery residencies participating in the National Resident Matching Program. Results Response rate was 200/239 (84%). A total of 381 out of 1052 trainees (36%) interrupt residency to pursue full-time research. The mean research fellowship length is 1.7 years, with 72% of trainees performing basic science research. A significant association was found between fellowship length and post-residency activity, with a 14.7% increase in clinical fellowship training and a 15.2% decrease in private practice positions for each year of full-time research (p<0.0001). Program directors at 31% of programs reported increased clinical duties for research fellows as a result of ACGME work hour regulations for clinical residents, while a further 10% of programs are currently considering such changes. It costs $41.5 million to pay the 634 trainees who perform research fellowships each year, the majority of which is paid for by departmental funds (40%) and institutional training grants (24%). Conclusions Interrupting residency to perform a research fellowship is a common and costly practice among general surgery residents. While performing a research fellowship is associated with clinical fellowship training after residency, it is unclear to what extent this practice leads to the development of surgical investigators after post-graduate training. PMID:19106692

Prevalence and cost of full-time research fellowships during general surgery residency: a national survey.

PubMed

Robertson, Charles M; Klingensmith, Mary E; Coopersmith, Craig M

2009-01-01

To quantify the prevalence, outcomes, and cost of surgical resident research. General surgery is unique among graduate medical education programs because a large percentage of residents interrupt their clinical training to spend 1 to 3 years performing full-time research. No comprehensive data exists on the scope of this practice. Survey sent to all 239 program directors of general surgery residencies participating in the National Resident Matching Program. Response rate was 200 of 239 (84%). A total of 381 of 1052 trainees (36%) interrupt residency to pursue full-time research. The mean research fellowship length is 1.7 years, with 72% of trainees performing basic science research. A significant association was found between fellowship length and postresidency activity, with a 14.7% increase in clinical fellowship training and a 15.2% decrease in private practice positions for each year of full-time research (P < 0.0001). Program directors at 31% of programs reported increased clinical duties for research fellows as a result of Accreditation Council for Graduate Medical Education work hour regulations for clinical residents, whereas a further 10% of programs are currently considering such changes. It costs $41.5 million to pay the 634 trainees who perform research fellowships each year, the majority of which is paid for by departmental funds (40%) and institutional training grants (24%). Interrupting residency to perform a research fellowship is a common and costly practice among general surgery residents. Although performing a research fellowship is associated with clinical fellowship training after residency, it is unclear to what extent this practice leads to the development of surgical investigators after postgraduate training.

42 CFR 68a.5 - Who is ineligible to participate?

Code of Federal Regulations, 2010 CFR

2010-10-01

..., INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR...: Physicians Shortage Area Scholarship Program, National Research Service Award Program, Public Health Service...) Professions Scholarship Program, Indian Health Service Scholarship Program, and the NIH AIDS Research Loan...

The National Institute of Dental Research Clinical Dental Staff Fellowship.

ERIC Educational Resources Information Center

Baum, Bruce J.; And Others

1988-01-01

A program in one of the National Institutes of Health offers clinical training fellowships as a means of training potential dental school faculty by providing both unique clinical skills and high-quality research experience. The program was developed in response to a perceived need for change in academic dentistry. (MSE)

Creating a "culture of research" in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program.

PubMed

Dimond, Eileen P; St Germain, Diane; Nacpil, Lianne M; Zaren, Howard A; Swanson, Sandra M; Minnick, Christopher; Carrigan, Angela; Denicoff, Andrea M; Igo, Kathleen E; Acoba, Jared D; Gonzalez, Maria M; McCaskill-Stevens, Worta

2015-06-01

The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute's Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period. To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials. The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish. The National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute-American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizational-level approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to implement yet proved valuable as they provided useful metrics for programmatic assessment, planning, reporting, and growth. While focused on oncology trials, these concepts may be useful within other disease-focused research as well. © The Author(s) 2015.

Clinical Trial Assessment of Infrastructure Matrix Tool to Improve the Quality of Research Conduct in the Community.

PubMed

Dimond, Eileen P; Zon, Robin T; Weiner, Bryan J; St Germain, Diane; Denicoff, Andrea M; Dempsey, Kandie; Carrigan, Angela C; Teal, Randall W; Good, Marjorie J; McCaskill-Stevens, Worta; Grubbs, Stephen S; Dimond, Eileen P; Zon, Robin T; Weiner, Bryan J; St Germain, Diane; Denicoff, Andrea M; Dempsey, Kandie; Carrigan, Angela C; Teal, Randall W; Good, Marjorie J; McCaskill-Stevens, Worta; Grubbs, Stephen S

2016-01-01

Several publications have described minimum standards and exemplary attributes for clinical trial sites to improve research quality. The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) developed the clinical trial Best Practice Matrix tool to facilitate research program improvements through annual self-assessments and benchmarking. The tool identified nine attributes, each with three progressive levels, to score clinical trial infrastructural elements from less to more exemplary. The NCCCP sites correlated tool use with research program improvements, and the NCI pursued a formative evaluation to refine the interpretability and measurability of the tool. From 2011 to 2013, 21 NCCCP sites self-assessed their programs with the tool annually. During 2013 to 2014, NCI collaborators conducted a five-step formative evaluation of the matrix tool. Sites reported significant increases in level-three scores across the original nine attributes combined (P<.001). Two specific attributes exhibited significant change: clinical trial portfolio diversity and management (P=.0228) and clinical trial communication (P=.0281). The formative evaluation led to revisions, including renaming the Best Practice Matrix as the Clinical Trial Assessment of Infrastructure Matrix (CT AIM), expanding infrastructural attributes from nine to 11, clarifying metrics, and developing a new scoring tool. Broad community input, cognitive interviews, and pilot testing improved the usability and functionality of the tool. Research programs are encouraged to use the CT AIM to assess and improve site infrastructure. Experience within the NCCCP suggests that the CT AIM is useful for improving quality, benchmarking research performance, reporting progress, and communicating program needs with institutional leaders. The tool model may also be useful in disciplines beyond oncology.

Promoting physical therapists' of research evidence to inform clinical practice: part 1--theoretical foundation, evidence, and description of the PEAK program.

PubMed

Tilson, Julie K; Mickan, Sharon

2014-06-25

There is a need for theoretically grounded and evidence-based interventions that enhance the use of research evidence in physical therapist practice. This paper and its companion paper introduce the Physical therapist-driven Education for Actionable Knowledge translation (PEAK) program, an educational program designed to promote physical therapists' integration of research evidence into clinical decision-making. The pedagogical foundations for the PEAK educational program include Albert Bandura's social cognitive theory and Malcolm Knowles's adult learning theory. Additionally, two complementary frameworks of knowledge translation, the Promoting Action on Research Implementation in Health Services (PARiHS) and Knowledge to Action (KTA) Cycle, were used to inform the organizational elements of the program. Finally, the program design was influenced by evidence from previous attempts to facilitate the use of research in practice at the individual and organizational levels. The 6-month PEAK program consisted of four consecutive and interdependent components. First, leadership support was secured and electronic resources were acquired and distributed to participants. Next, a two-day training workshop consisting of didactic and small group activities was conducted that addressed the five steps of evidence based practice. For five months following the workshop, participants worked in small groups to review and synthesize literature around a group-selected area of common clinical interest. Each group contributed to the generation of a "Best Practices List" - a list of locally generated, evidence-based, actionable behaviors relevant to the groups' clinical practice. Ultimately, participants agreed to implement the Best Practices List in their clinical practice. This, first of two companion papers, describes the underlying pedagogical theories, knowledge translation frameworks, and research evidence used to derive the PEAK program - an educational program designed to promote the use of research evidence to inform physical therapist practice. The four components of the program are described in detail. The companion paper reports the results of a mixed methods feasibility analysis of this complex educational intervention.

Stimulating student interest in nursing research: a program pairing students with practicing clinician researchers.

PubMed

Kennel, Susan; Burns, Suzanne; Horn, Heather

2009-04-01

Teaching nursing research to baccalaureate nursing (BSN) students can be challenging for nurse educators. The content of research courses often is dry and seemingly irrelevant to BSN students who are focused on more concrete tasks, such as passing clinical and academic courses. Through our search for creative ways to bring energy, excitement, passion, purpose, and reality to students' views of nursing research, we designed a program in which hospital nurses involved in clinical research projects mentored students in the clinical environment. Students were asked to perform literature reviews, collect and analyze data, and help with poster presentations. Student evaluations at the end of the program were positive, and analysis of pretest and posttest scores indicated student interest in nursing research increased significantly (p = 0.00).

Competency-Based Assessment for Clinical Supervisors: Design-Based Research on a Web-Delivered Program

PubMed Central

Williams, Lauren Therese; Grealish, Laurie; Jamieson, Maggie

2015-01-01

Background Clinicians need to be supported by universities to use credible and defensible assessment practices during student placements. Web-based delivery of clinical education in student assessment offers professional development regardless of the geographical location of placement sites. Objective This paper explores the potential for a video-based constructivist Web-based program to support site supervisors in their assessments of student dietitians during clinical placements. Methods This project was undertaken as design-based research in two stages. Stage 1 describes the research consultation, development of the prototype, and formative feedback. In Stage 2, the program was pilot-tested and evaluated by a purposeful sample of nine clinical supervisors. Data generated as a result of user participation during the pilot test is reported. Users’ experiences with the program were also explored via interviews (six in a focus group and three individually). The interviews were transcribed verbatim and thematic analysis conducted from a pedagogical perspective using van Manen’s highlighting approach. Results This research succeeded in developing a Web-based program, “Feed our Future”, that increased supervisors’ confidence with their competency-based assessments of students on clinical placements. Three pedagogical themes emerged: constructivist design supports transformative Web-based learning; videos make abstract concepts tangible; and accessibility, usability, and pedagogy are interdependent. Conclusions Web-based programs, such as Feed our Future, offer a viable means for universities to support clinical supervisors in their assessment practices during clinical placements. A design-based research approach offers a practical process for such Web-based tool development, highlighting pedagogical barriers for planning purposes. PMID:25803172

A change roadmap towards research paradigm in low-resource countries: retinoblastoma model in Egypt.

PubMed

Alfaar, Ahmad Samir; Nour, Radwa; Bakry, Mohamed Sabry; Kamal, Mohamed; Hassanain, Omneya; Labib, Rania M; Rashed, Wafaa M; Elzomor, Hossam; Alieldin, Adel; Taha, Hala; Zaghloul, Mohamed Saad; Ezzat, Sameera; AboElnaga, Sherif

2017-02-01

Research on childhood diseases represents a great global challenge. This challenge is maximized in both childhood cancer disciplines and developing world. In this paper, we aim at describing our institution experience in starting a structured childhood cancer research program in one of the developing countries in a short time based on philanthropic efforts. We used retinoblastoma as an example for what was conducted in this program. Starting in 2008, this program included improving clinical practice and its related supporting services besides developing new research services that both complement the clinical activities and pave the way towards creating a research foundation in the country. Results included developing hospital standard treatment protocols, developing national clinical trials, joining international consortia for childhood cancers clinical trials, developing data collection tools and real-time analytics, establishing a biobanking facility, and developing highly qualified team for conducting clinical, epidemiologic, and translational research studies. Moreover, this effort resulted in improving both clinical practice and patients' awareness nationally. This model can be used for other startup facilities that aim at finding answers for their national health problems in low-resource setting.

Comprehensive Opportunities for Research and Teaching Experience (CORTEX): A mentorship program.

PubMed

Zuzuárregui, José Rafael P; Hohler, Anna D

2015-06-09

We developed a program to promote medical student interest in pursuing a career in neurology. This program focuses on medical student mentorship. It also offers opportunities in teaching and clinical research in order to provide students with marketable skills for an academic career in neurology. Through this program, students are provided with guidance in developing a fourth-year clerkship schedule and an application package for residency programs. Students are involved and mentored in clinical research. Opportunities are also provided for students to teach their peers, with sessions focusing on examination preparation. Since the implementation of this program in 2010, the number of students entering into the field of neurology from our institution significantly increased from 14 students between 2006 and 2010, to 30 students between 2011 and 2014 (p < 0.05). Medical student research productivity increased from 7 publications during 2006-2010, to 22 publications, 14 poster presentations, and a book chapter after implementation of this program in 2010 (p < 0.05). In this mentoring program, students are prepared for residency application and provided with research and teaching opportunities. Students develop a highly desirable academic skill set for residency and have matched at top-ranked institutions. This program has been successful in improving student productivity in clinical research and garnering student interest in neurology. © 2015 American Academy of Neurology.

Emergency Medicine Resources Within the Clinical Translational Science Institutes: A Cross-sectional Study.

PubMed

Meurer, William J; Quinn, James; Lindsell, Christopher; Schneider, Sandra; Newgard, Craig D

2016-06-01

The Clinical and Translational Science Award (CTSA) program aims to strengthen and support translational research by accelerating the process of translating laboratory discoveries into treatments for patients, training a new generation of clinical and translational researchers, and engaging communities in clinical research efforts. Yet, little is known about how emergency care researchers have interacted with and utilized the resources of academic institutions with CTSAs. The purpose of this survey was to describe how emergency care researchers use local CTSA resources, to ascertain what proportion of CTSA consortium members have active emergency care research (ECR) programs, and to solicit participation in a national CTSA-associated emergency care translational research network. This study was a survey of all emergency departments affiliated with a CTSA. Of the 65 CTSA consortium members, three had no ECR program and we obtained responses from 46 of the remaining 62 (74% response rate). The interactions with and resources used by emergency care researchers varied widely. Methodology and biostatistics support was most frequently accessed (77%), followed closely by education and training programs (60%). Several ECR programs (76%) had submitted for funding through CTSAs, with 71% receiving awards. Most CTSA consortium members had an active ECR infrastructure: 21 (46%) had 24/7 availability to recruit and screen for research, and 21 (46%) had less than 24/7 research recruitment. A number of emergency care research programs participated in National Institutes of Health research networks with the Neurological Emergencies Treatment Trials network most highly represented with 23 (59%) sites. Most ECR programs (96%) were interested in participating in a CTSA-based emergency care translational research network. Despite little initial involvement in development of the CTSA program, there has been moderate interaction between CTSAs and emergency care. There is considerable interest in participating in a CTSA consortium-based emergency care translational research network. © 2016 by the Society for Academic Emergency Medicine.

Advancing Translational Research Through the NHLBI Gene Therapy Resource Program (GTRP)

PubMed Central

Benson, Janet; Cornetta, Kenneth; Diggins, Margaret; Johnston, Julie C.; Sepelak, Susan; Wang, Gensheng; Wilson, James M.; Wright, J. Fraser; Skarlatos, Sonia I.

2013-01-01

Abstract Translational research is a lengthy, complex, and necessary endeavor in order to bring basic science discoveries to clinical fruition. The NIH offers several programs to support translational research including an important resource established specifically for gene therapy researchers—the National Heart, Lung, and Blood Institute (NHLBI) Gene Therapy Resource Program (GTRP). This paper reviews the core components of the GTRP and describes how the GTRP provides researchers with resources that are critical to advancing investigational gene therapy products into clinical testing. PMID:23692378

77 FR 68138 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-15

... Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally... Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged...

Increasing the ranks of academic researchers in mental health: a multisite approach to postdoctoral fellowship training.

PubMed

O'Hara, Ruth; Cassidy-Eagle, Erin L; Beaudreau, Sherry A; Eyler, Lisa T; Gray, Heather L; Giese-Davis, Janine; Hubbard, Jeffrey; Yesavage, Jerome A

2010-01-01

This report highlights the use of multisite training for psychiatry and psychology postdoctoral fellows developing careers in academic clinical research in the field of mental health. The objective is to describe a model of training for young investigators to establish independent academic clinical research careers, including (1) program structure and eligibility, (2) program goals and development of a multisite curriculum, (3) use of technology for implementing the program across multiple sites, and (4) advantages and challenges of this multisite approach. In 2000, in collaboration with the Veterans Affairs (VA) Mental Illness Research, Education and Clinical Centers (MIRECCs), the VA Office of Academic Affiliations launched the Special Fellowship Program in Advanced Psychiatry and Psychology. Each of the 10 currently participating VA sites across the United States is affiliated with a MIRECC and an academic medical institution. In the first five years of this fellowship program, 83 fellows (34 psychiatrists and 49 psychologists) have participated. The success of this multisite approach is evidenced by the 58 fellows who have already graduated from the program: 70% have entered academic clinical research positions, and over 25 have obtained independent extramural grant support from the VA or the National Institutes of Health. Multisite training results in a greater transfer of knowledge and capitalizes on the nationwide availability of experts, creating unique networking and learning opportunities for trainees. The VA's multisite fellowship program plays a valuable role in preparing substantial numbers of psychiatry and psychology trainees for a range of academic clinical research and leadership positions in the field of mental health.

A distributed model: redefining a robust research subject advocacy program at the Harvard Clinical and Translational Science Center.

PubMed

Winkler, Sabune J; Cagliero, Enrico; Witte, Elizabeth; Bierer, Barbara E

2014-08-01

The Harvard Clinical and Translational Science Center ("Harvard Catalyst") Research Subject Advocacy (RSA) Program has reengineered subject advocacy, distributing the delivery of advocacy functions through a multi-institutional, central platform rather than vesting these roles and responsibilities in a single individual functioning as a subject advocate. The program is process-oriented and output-driven, drawing on the strengths of participating institutions to engage local stakeholders both in the protection of research subjects and in advocacy for subjects' rights. The program engages stakeholder communities in the collaborative development and distributed delivery of accessible and applicable educational programming and resources. The Harvard Catalyst RSA Program identifies, develops, and supports the sharing and distribution of expertise, education, and resources for the benefit of all institutions, with a particular focus on the frontline: research subjects, researchers, research coordinators, and research nurses. © 2014 Wiley Periodicals, Inc.

Multicenter External Quality Assessment Program for PCR Detection of Mycobacterium ulcerans in Clinical and Environmental Specimens

PubMed Central

Eddyani, Miriam; Lavender, Caroline; de Rijk, Willem Bram; Bomans, Pieter; Fyfe, Janet; de Jong, Bouke; Portaels, Françoise

2014-01-01

Background Mycobacterium ulcerans is the causative agent of Buruli ulcer (BU), a necrotizing disease of the skin, soft tissue and bone. PCR is increasingly used in the diagnosis of BU and in research on the mode of transmission and environmental reservoir of M. ulcerans. Methodology/Principal Findings The aim of this study was to evaluate the performance of laboratories in detecting M. ulcerans using molecular tests in clinical and environmental samples by implementing sequential multicenter external quality assessment (EQA) programs. The second round of the clinical EQA program revealed somewhat improved performance. Conclusions/Significance Ongoing EQA programs remain essential and continued participation in future EQA programs by laboratories involved in the molecular testing of clinical and environmental samples for M. ulcerans for diagnostic and research purposes is strongly encouraged. Broad participation in such EQA programs also benefits the harmonization of quality in the BU research community and enhances the credibility of advances made in solving the transmission enigma of M. ulcerans. PMID:24586755

Implementation of a volunteer university student research assistant program in an emergency department: the nuts and bolts for success.

PubMed

Steadman, Patrick E; Crudden, Johanna; Boutis, Kathy

2015-09-01

Prospective research studies often advance clinical practice in the emergency department (ED), but they can be costly and difficult to perform. In this report, we describe the implementation of a volunteer university student research assistant program that provides students exposure to medicine and clinical research while simultaneously increasing the capacity of an ED's research program. This type of program provides 15 hours per day of research assistant coverage for patient screening and enrolment for minimal risk research studies, and screening for higher risk studies. The latter is true without the added burden or costs of co-administering university course credit or pay for service, which are common features of most of these types of programs currently in operation. We have shown that our volunteer-based program is effective for an ED's research success as well as for its student participants. For other EDs interested in adopting similar programs, we provide the details on how to get such a program started and highlight the structure and non-monetary incentives that facilitate a program's ongoing success.

Unpacking the Clinical and Participatory Dimensions of the Trump Math-Teacher-Residency-Program

ERIC Educational Resources Information Center

Imanuel-Noy, Dalia; Wagner, Tili

2016-01-01

The research presents a Residency Math teacher education program that has been developed in Israel in search of transforming initial teacher preparation on the Clinical-Participatory continuum. It is a "multi-phase" mixed-method research aiming to present the clinical and participatory dimensions of the TMR: the way in which they are…

Program History

Cancer.gov

Learn how the National Cancer Institute transitioned the former Cooperative Groups Program to the National Clinical Trials Network (NCTN) program. The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

My Librarian: Personalized Research Clinics and the Academic Library.

ERIC Educational Resources Information Center

Cardwell, Catherine; Furlong, Katherine; O'Keeffe, Julie

2002-01-01

Describes personalized research clinics (PRC) programs at three diverse institutions: Gettysburg College (Pennsylvania), Marquette University (Wisconsin), and Bowling Green State University (Ohio). Addresses logistics, publicity methods, program analysis, and assessment issues, and weighs the benefits of the labor-intensive service against other…

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

PubMed Central

Mapes, Brandy; Basford, Melissa; Zufelt, Anneliese; Wehbe, Firas; Harris, Paul; Alcorn, Michael; Allen, David; Arnim, Margaret; Autry, Susan; Briggs, Michael S.; Carnegie, Andrea; Chavis‐Keeling, Deborah; De La Pena, Carlos; Dworschak, Doris; Earnest, Julie; Grieb, Terri; Guess, Marilyn; Hafer, Nathaniel; Johnson, Tesheia; Kasper, Amanda; Kopp, Janice; Lockie, Timothy; Lombardo, Vincetta; McHale, Leslie; Minogue, Andrea; Nunnally, Beth; O'Quinn, Deanna; Peck, Kelly; Pemberton, Kieran; Perry, Cheryl; Petrie, Ginny; Pontello, Andria; Posner, Rachel; Rehman, Bushra; Roth, Deborah; Sacksteder, Paulette; Scahill, Samantha; Schieri, Lorri; Simpson, Rosemary; Skinner, Anne; Toussant, Kim; Turner, Alicia; Van der Put, Elaine; Wasser, June; Webb, Chris D.; Williams, Maija; Wiseman, Lori; Yasko, Laurel; Pulley, Jill

2014-01-01

Abstract The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources. PMID:24456567

Evaluation and implementation of highly challenging balance training in clinical practice for people with Parkinson's disease: protocol for the HiBalance effectiveness-implementation trial.

PubMed

Leavy, Breiffni; Kwak, Lydia; Hagströmer, Maria; Franzén, Erika

2017-02-07

If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented. The HiBalance program is systemically designed to target balance impairments in PD and has been shown effective at improving balance control and gait in a previous RCT. Study aims are to i) determine the effectiveness of the adapted HiBalance program on performance and self-rated outcomes such as balance control, gait and physical activity level ii) conduct a process evaluation of program implementation at the various clinics iii) determine barriers and facilitators to program implementation in these settings. This effectiveness-implementation type 1 hybrid study will use a non-randomized controlled design with consecutive inclusion of people with PD at multiple clinical sites. A mixed method approach will be used to collect clinical effectiveness data and process evaluation data which is both quantitative and qualitative in nature. The consolidated framework for implementation research (CFIR) will be used to guide the planning and collection of data concerning implementation barriers and facilitators. The HiBalance program will be provided by physical therapists as a part of standard rehabilitation care at the clinical sites, while the evaluation of the implementation process will be performed by the research group and funded by research grants. An effectiveness-implementation study design benefits patients by speeding up the process of translating findings from research settings to routine health care. Findings from this study will also be highly relevant for those working with neurological rehabilitation when faced with decisions concerning the translation of training programs from efficacy studies to everyday clinical practice. ClinicalTrials.gov march 2016, NCT02727478 .

Puerto Rico NCI Community Oncology Research Program Minority/Underserved | Division of Cancer Prevention

Cancer.gov

The Puerto Rico NCI Community Oncology Research Program (PRNCORP) will be the principal organization in the island that promotes cancer prevention, control and screening/post-treatment surveillance clinical trials. It will conduct cancer care delivery research and will provide access to treatment and imaging clinical trials conducted under the reorganization of the National

Teaching Translational Research to Medical Students: The New York University School of Medicine's Master's of Science in Clinical Investigation Dual-Degree Program.

PubMed

Gillman, Jennifer; Pillinger, Michael; Plottel, Claudia S; Galeano, Claudia; Maddalo, Scott; Hochman, Judith S; Cronstein, Bruce N; Gold-von Simson, Gabrielle

2015-12-01

To develop the next generation of translational investigators, New York University School of Medicine (NYUSOM) and the NYU-NYC Health and Hospitals Corporation Clinical and Translational Science Institute (NYU-HHC CTSI) developed the Master's of Science in Clinical Investigation dual-degree (MD/MSCI) program. This 5-year program dedicates 1 year to coursework and biomedical research, followed by a medical school/research overlap year, to prepare students for academic research careers. This paper details the MD/MSCI program's curriculum and approach to mentorship, describes the research/professional interests of students, and reports student productivity. In the first 4 years of the program (2010-2014) 20 students were matriculated; 7 (35%) were women, and 12 (60%) research projects were in surgical specialties. To date, 14 students have applied to residency, and half pursued surgical residency programs. Our students have produced 68 accepted abstracts, 15 abstracts in submission, 38 accepted papers, and 24 papers in submission. Despite the time-limited nature of this program, additional training in research design and implementation has promoted a high level of productivity. We conclude that dual-degree training in medicine and translational research is feasible for medical students and allows for meaningful participation in valuable projects. Follow-up is warranted to evaluate the academic trajectory of these students. © 2015 Wiley Periodicals, Inc.

Teaching Translational Research to Medical Students: The New York University School of Medicine's Master's of Science in Clinical Investigation Dual‐Degree Program

PubMed Central

Pillinger, Michael; Plottel, Claudia S.; Galeano, Claudia; Maddalo, Scott; Hochman, Judith S.; Cronstein, Bruce N.; Gold‐von Simson, Gabrielle

2015-01-01

Abstract To develop the next generation of translational investigators, New York University School of Medicine (NYUSOM) and the NYU‐NYC Health and Hospitals Corporation Clinical and Translational Science Institute (NYU‐HHC CTSI) developed the Master's of Science in Clinical Investigation dual‐degree (MD/MSCI) program. This 5‐year program dedicates 1 year to coursework and biomedical research, followed by a medical school/research overlap year, to prepare students for academic research careers. This paper details the MD/MSCI program's curriculum and approach to mentorship, describes the research/professional interests of students, and reports student productivity. In the first 4 years of the program (2010–2014) 20 students were matriculated; 7 (35%) were women, and 12 (60%) research projects were in surgical specialties. To date, 14 students have applied to residency, and half pursued surgical residency programs. Our students have produced 68 accepted abstracts, 15 abstracts in submission, 38 accepted papers, and 24 papers in submission. Despite the time‐limited nature of this program, additional training in research design and implementation has promoted a high level of productivity. We conclude that dual‐degree training in medicine and translational research is feasible for medical students and allows for meaningful participation in valuable projects. Follow‐up is warranted to evaluate the academic trajectory of these students. PMID:26365704

Effective Strategies for Global Health Research, Training and Clinical Care: A Narrative Review

PubMed Central

Walker, Rebekah J.; Campbell, Jennifer A.; Egede, Leonard E.

2015-01-01

The purpose of this narrative review was to synthesize the evidence on effective strategies for global health research, training and clinical care in order to identify common structures that have been used to guide program development. A Medline search from 2001 to 2011 produced 951 articles, which were reviewed and categorized. Thirty articles met criteria to be included in this review. Eleven articles discussed recommendations for research, 8 discussed training and 11 discussed clinical care. Global health program development should be completed within the framework of a larger institutional commitment or partnership. Support from leadership in the university or NGO, and an engaged local community are both integral to success and sustainability of efforts. It is also important for program development to engage local partners from the onset, jointly exploring issues and developing goals and objectives. Evaluation is a recommended way to determine if goals are being met, and should include considerations of sustainability, partnership building, and capacity. Global health research programs should consider details regarding the research process, context of research, partnerships, and community relationships. Training for global health should involve mentorship, pre-departure preparation of students, and elements developed to increase impact. Clinical care programs should focus on collaboration, sustainability, meeting local needs, and appropriate process considerations. PMID:25716404

Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for research nurses to join our clinical program to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, ensuring adherence to ethical practice in the conduct of clinical trials, research protocol compliance and good clinical practice, ensuring patient comprehension of informed consent, management of care

An international basic science and clinical research summer program for medical students.

PubMed

Ramjiawan, Bram; Pierce, Grant N; Anindo, Mohammad Iffat Kabir; Alkukhun, Abedalrazaq; Alshammari, Abdullah; Chamsi, Ahmad Talal; Abousaleh, Mohannad; Alkhani, Anas; Ganguly, Pallab K

2012-03-01

An important part of training the next generation of physicians is ensuring that they are exposed to the integral role that research plays in improving medical treatment. However, medical students often do not have sufficient time to be trained to carry out any projects in biomedical and clinical research. Many medical students also fail to understand and grasp translational research as an important concept today. In addition, since medical training is often an international affair whereby a medical student/resident/fellow will likely train in many different countries during his/her early training years, it is important to provide a learning environment whereby a young medical student experiences the unique challenges and value of an international educational experience. This article describes a program that bridges the gap between the basic and clinical research concepts in a unique international educational experience. After completing two semester curricula at Alfaisal University in Riyadh, Kingdom of Saudi Arabia, six medical students undertook a summer program at St. Boniface Hospital Research Centre, in Winnipeg, MB, Canada. The program lasted for 2 mo and addressed advanced training in basic science research topics in medicine such as cell isolation, functional assessment, and molecular techniques of analysis and manipulation as well as sessions on the conduct of clinical research trials, ethics, and intellectual property management. Programs such as these are essential to provide a base from which medical students can decide if research is an attractive career choice for them during their clinical practice in subsequent years. An innovative international summer research course for medical students is necessary to cater to the needs of the medical students in the 21st century.

Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-2-0159 TITLE: Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies PRINCIPAL INVESTIGATOR...Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for...AND SUBTITLE Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT

77 FR 28887 - Office of the Director, National Institutes of Health, Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

... Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment... Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from.../Outreach Program Specialist, Office of Communications and Public Liaison, Office of the Director, National...

75 FR 63493 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment... Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from..., Executive Secretary/Outreach Program Specialist, Office of Communications and Public Liaison, Office of the...

42 CFR 68a.9 - What loans qualify for repayment?

Code of Federal Regulations, 2010 CFR

2010-10-01

..., INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR... following programs: Physicians Shortage Area Scholarship Program (Federal or State), National Research...

Manufacturing/Cell Therapy Specialist | Center for Cancer Research

Cancer.gov

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID),

Quality Control Specialist | Center for Cancer Research

Cancer.gov

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID),

Promoting Bedside Nurse-Led Research Through a Dedicated Neuroscience Nursing Research Fellowship.

PubMed

Stutzman, Sonja; Olson, DaiWai; Supnet, Charlene; Harper, Caryn; Brown-Cleere, Shelley; McCulley, Becky; Goldberg, Mark

2016-12-01

We hypothesized that nurses would benefit from the fellowship model traditionally used to engage physicians in clinical research. The Neuroscience Nursing Research Center (NNRC) fellowship program was created as a model for engaging nurses at all levels of clinical practice to become active in clinical research. The NNRC was established in 2013 as a novel approach to promote bedside nurses as primary investigators in clinical research. The NNRC developed 4 pathways to nursing research success: research fellowship, student-nurse internship, didactic training, and research consultation. Fellows have enrolled more than 900 participants in 14 studies. Nurses have presented more than 20 abstracts at 12 conferences and submitted 11 manuscripts for publication. The NNRC has provided research training to more than 150 nurses. The NNRC program is successful in engaging nurses in research. It shows promise to continue to develop nursing research that is applicable to clinicians and thus improve patient care.

Biomedical research, development, and engineering at the Johns Hopkins University Applied Physics Laboratory. Annual report 1 October 1978-30 September 1979

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

The Medical Institutions of The Johns Hopkins University and The Johns Hopkins University Applied Physics Laboratory have developed a vigorous collaborative program of biomedical research, development, and systems engineering. An important objective of the program is to apply the expertise in engineering, the physical sciences, and systems analysis acquired by APL in defense and space research and development to problems of medical research and health care delivery. This program has grown to include collaboration with many of the clinical and basic science departments of the medical divisions. Active collaborative projects exist in ophthalmology, neurosensory research and instrumentation development, cardiovascular systems,more » patient monitoring, therapeutic and rehabilitation systems, clinical information systems, and clinical engineering. This application of state-of-the-art technology has contributed to advances in many areas of basic medical research and in clinical diagnosis and therapy through improvement of instrumentation, techniques, and basic understanding.« less

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

PubMed

Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

2014-02-01

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

Adolescent Bariatric Surgery Program Characteristics: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study Experience

PubMed Central

Michalsky, M.P.; Inge, T.H.; Teich, S.; Eneli, I.; Miller, R.; Brandt, M.L.; Helmrath, M.; Harmon, C.M.; Zeller, M.H.; Jenkins, T.M.; Courcoulas, A.; Buncher, C.R.

2013-01-01

Background The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Methods Data were obtained from the Teen-LABS database and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. Results All centers had extensive multidisciplinary involvement in the assessment, preoperative education and post-operative management of adolescents undergoing WLS. Eligibility criteria, pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. Conclusions The composition of clinical team and institutional resources are consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. PMID:24491361

Creating a “culture of research” in a community hospital: Strategies and tools from the National Cancer Institute Community Cancer Centers Program

PubMed Central

St. Germain, Diane; Nacpil, Lianne M; Zaren, Howard A; Swanson, Sandra M; Minnick, Christopher; Carrigan, Angela; Denicoff, Andrea M; Igo, Kathleen E; Acoba, Jared D; Gonzalez, Maria M; McCaskill-Stevens, Worta

2015-01-01

Background The value of community-based cancer research has long been recognized. In addition to the National Cancer Institute’s Community Clinical and Minority-Based Oncology Programs established in 1983, and 1991 respectively, the National Cancer Institute established the National Cancer Institute Community Cancer Centers Program in 2007 with an aim of enhancing access to high-quality cancer care and clinical research in the community setting where most cancer patients receive their treatment. This article discusses strategies utilized by the National Cancer Institute Community Cancer Centers Program to build research capacity and create a more entrenched culture of research at the community hospitals participating in the program over a 7-year period. Methods To facilitate development of a research culture at the community hospitals, the National Cancer Institute Community Cancer Centers Program required leadership or chief executive officer engagement; utilized a collaborative learning structure where best practices, successes, and challenges could be shared; promoted site-to-site mentoring to foster faster learning within and between sites; required research program assessments that spanned clinical trial portfolio, accrual barriers, and outreach; increased identification and use of metrics; and, finally, encouraged research team engagement across hospital departments (navigation, multidisciplinary care, pathology, and disparities) to replace the traditionally siloed approach to clinical trials. Limitations The health-care environment is rapidly changing while complexity in research increases. Successful research efforts are impacted by numerous factors (e.g. institutional review board reviews, physician interest, and trial availability). The National Cancer Institute Community Cancer Centers Program sites, as program participants, had access to the required resources and support to develop and implement the strategies described. Metrics are an important component yet often challenging to identify and collect. The model requires a strong emphasis on outreach that challenges hospitals to improve and expand their reach, particularly into underrepresented populations and catchment areas. These efforts build on trust and a referral pipeline within the community which take time and significant commitment to establish. Conclusion The National Cancer Institute Community Cancer Centers Program experience provides a relevant model to broadly address creating a culture of research in community hospitals that are increasingly networked via systems and consortiums. The strategies used align well with the National Cancer Institute—American Society of Clinical Oncology Accrual Symposium recommendations for patient-/community-, physician-/provider-, and site-/organizational-level approaches to clinical trials; they helped sites achieve organizational culture shifts that enhanced their cancer research programs. The National Cancer Institute Community Cancer Centers Program hospitals reported that the strategies were challenging to implement yet proved valuable as they provided useful metrics for programmatic assessment, planning, reporting, and growth. While focused on oncology trials, these concepts may be useful within other disease-focused research as well. PMID:25691600

78 FR 15022 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds..., Director of Scientific and Program Operations, Office of Aids Research, Office of the Director, NIH, 5635...

Promoting physical therapists’ of research evidence to inform clinical practice: part 1 - theoretical foundation, evidence, and description of the PEAK program

PubMed Central

2014-01-01

Background There is a need for theoretically grounded and evidence-based interventions that enhance the use of research evidence in physical therapist practice. This paper and its companion paper introduce the Physical therapist-driven Education for Actionable Knowledge translation (PEAK) program, an educational program designed to promote physical therapists’ integration of research evidence into clinical decision-making. The pedagogical foundations for the PEAK educational program include Albert Bandura’s social cognitive theory and Malcolm Knowles’s adult learning theory. Additionally, two complementary frameworks of knowledge translation, the Promoting Action on Research Implementation in Health Services (PARiHS) and Knowledge to Action (KTA) Cycle, were used to inform the organizational elements of the program. Finally, the program design was influenced by evidence from previous attempts to facilitate the use of research in practice at the individual and organizational levels. Discussion The 6-month PEAK program consisted of four consecutive and interdependent components. First, leadership support was secured and electronic resources were acquired and distributed to participants. Next, a two-day training workshop consisting of didactic and small group activities was conducted that addressed the five steps of evidence based practice. For five months following the workshop, participants worked in small groups to review and synthesize literature around a group-selected area of common clinical interest. Each group contributed to the generation of a “Best Practices List” - a list of locally generated, evidence-based, actionable behaviors relevant to the groups’ clinical practice. Ultimately, participants agreed to implement the Best Practices List in their clinical practice. Summary This, first of two companion papers, describes the underlying pedagogical theories, knowledge translation frameworks, and research evidence used to derive the PEAK program – an educational program designed to promote the use of research evidence to inform physical therapist practice. The four components of the program are described in detail. The companion paper reports the results of a mixed methods feasibility analysis of this complex educational intervention. PMID:24965501

Geropsychology training in a specialist geropsychology doctoral program.

PubMed

Qualls, Sara Honn; Segal, Daniel L; Benight, Charles C; Kenny, Michael P

2005-01-01

The first PhD specialty program in Geropsychology that launched in fall, 2004 at CU-Colorado Springs is described. Consistent with a scientist-practitioner model, the curriculum sequence builds systematically from basic to complex knowledge and skills across the domains of scientific psychology, research methodology, general clinical, geropsychology science, and clinical geropsychology. Practicum experiences also build skills in core clinical competencies needed by geropsychologists, including assessment, psychotherapy, neuropsychological evaluations, caregiver consultation and counseling, health psychology, and outreach/prevention. Research mentoring prepares students with the skills needed to conduct independent research useful to the clinical practice of geropsychology. Challenges faced in the process of developing the program include the development of a training clinic, balancing specialty and generalized training, building a specialty culture while maintaining faculty integration, attracting faculty and students during a start-up phase, and defining an identity within the field. The mental health services center that was launched to meet training needs while addressing a services niche in the community contributes substantially to the essence of this program, and is described in some detail. Future opportunities and challenges include program funding, heavy demands of specialty training on top of generalist training, maintaining congruence between expectations of clinical and non-clinical faculty, providing interdisciplinary experience, and expansion of practicum opportunities.

Implementation of new clinical programs in the VHA healthcare system: the importance of early collaboration between clinical leadership and research.

PubMed

Wu, R Ryanne; Kinsinger, Linda S; Provenzale, Dawn; King, Heather A; Akerly, Patricia; Barnes, Lottie K; Datta, Santanu K; Grubber, Janet M; Katich, Nicholas; McNeil, Rebecca B; Monte, Robert; Sperber, Nina R; Atkins, David; Jackson, George L

2014-12-01

Collaboration between policy, research, and clinical partners is crucial to achieving proven quality care. The Veterans Health Administration has expended great efforts towards fostering such collaborations. Through this, we have learned that an ideal collaboration involves partnership from the very beginning of a new clinical program, so that the program is designed in a way that ensures quality, validity, and puts into place the infrastructure necessary for a reliable evaluation. This paper will give an example of one such project, the Lung Cancer Screening Demonstration Project (LCSDP). We will outline the ways that clinical, policy, and research partners collaborated in design, planning, and implementation in order to create a sustainable model that could be rigorously evaluated for efficacy and fidelity. We will describe the use of the Donabedian quality matrix to determine the necessary characteristics of a quality program and the importance of the linkage with engineering, information technology, and clinical paradigms to connect the development of an on-the-ground clinical program with the evaluation goal of a learning healthcare organization. While the LCSDP is the example given here, these partnerships and suggestions are salient to any healthcare organization seeking to implement new scientifically proven care in a useful and reliable way.

Integrating Single-System Design Research into the Clinical Practice Class

ERIC Educational Resources Information Center

Cooper, Marlene G.

2006-01-01

Clinical practice and research are generally taught separately in Master of Social Work programs by faculty with distinct areas of expertise. This paper discusses the teaching of single-subject design research methodology by clinical faculty, in the clinical practice class. Examples from student papers demonstrate the effectiveness of integrating…

Improving Defense Health Program Medical Research Processes

DTIC Science & Technology

2017-08-08

needed for DHP medical research , such as the Army’s Clinical and Translational Research Program Office, 38 the Navy’s Research Methods Training Program... research stated, “key infrastructure for a learning health system will encompass three core elements: data networks, methods , and workforce.” 221 A 2012... Research Methods Training Program, 132 which will be further discussed in Appendix D.2. AIR FORCE Air Force Instruction 40-402, Protection of

School-Based Health Clinics: An Analysis of the Johns Hopkins Study. Research Developments.

ERIC Educational Resources Information Center

Demsko, Tobin W.

School-based health clinics, adolescent pregnancy prevention programs offering comprehensive health services, represent the latest initiative to reduce the incidence of teenage pregnancy. Researchers at Johns Hopkins University designed and administered a pregnancy prevention program which offered sexuality education and family planning services…

The DREAMS Team: Creating Community Partnerships through Research Advocacy Training for Diverse Older Adults

ERIC Educational Resources Information Center

Hart, Ariel R.; Dillard, Rebecca; Perkins, Molly M.; Vaughan, Camille P.; Kinlaw, Kathy; McKay, J. Lucas; Waldrop-Valverde, Drenna; Hagen, Kimberley; Wincek, Ron C.; Hackney, Madeleine E.

2017-01-01

The DREAMS Team research advocacy training program helps clinical faculty and health students introduce basic clinical research concepts to diverse older adults to galvanize their active involvement in the research process. Older adults are frequently underrepresented in clinical research, due to barriers to participation including distrust,…

NIH Clinical Center: There’s No Other Hospital Like It | NIH MedlinePlus the Magazine

MedlinePlus

... scientists. The innovative curriculum includes courses in pharmacology, principles and practice of clinical research, and bioethics. Recently, the NIH Clinical Center launched the Sabbatical in Clinical Research Management program for clinical investigators, healthcare managers and administrators, ...

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

NCI: DCTD: Biometric Research Program

Cancer.gov

The Biometric Research Program (BRP) is the statistical and biomathematical component of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC). Its members provide statistical leadership for the national and international research programs of the division in developmental therapeutics, developmental diagnostics, diagnostic imaging and clinical trials.

NCI: DCTD: Biometric Research Program

Cancer.gov

The Biometric Research Program (BRB) is the statistical and biomathematical component of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC). Its members provide statistical leadership for the national and international research programs of the division in developmental therapeutics, developmental diagnostics, diagnostic imaging and clinical trials.

75 FR 60465 - Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

.... 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Division of Program...

PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

PubMed Central

Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; MV, Deepa; Alam, Sazid; Jain, Sarika; Alapati, Bhavana; Mittal, Sanjay; Singh, Padam

2013-01-01

Background A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. Objective To study public knowledge and perceptions of clinical research. Methods A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. Results Interviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%). Conclusions Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues. PMID:23874712

Urologic Oncology Branch - Training - NCI/AFUD | Center for Cancer Research

Cancer.gov

Postdoctoral Research Training Program This program is designed to train Ph.D. postdoctoral scientists in the growing field of urologic oncology. This program offers fellows the opportunity to participate in a diverse training experience that includes clinical and laboratory research on several urologic malignancies. The program provides an opportunity for selected individuals

Research training of Developmental-Behavioral Pediatrics fellows: a survey of fellowship directors by Developmental-Behavioral Pediatrics Research Network.

PubMed

Wiley, Susan; Schonfeld, David J; Fredstrom, Bridget; Huffman, Lynne

2013-01-01

To describe research training in Developmental-Behavioral Pediatrics (DBP) Fellowship Programs. Thirty-five US-accredited DBP fellowships were contacted through the Developmental-Behavioral Pediatrics Research Network to complete an online survey on scholarly work and research training. With an 83% response rate, responding programs represented 110 (87 filled) fellowship positions. External funding for fellowship positions was minimal (11 positions fully funded, 13 funded above 50% of cost). Structured research training included didactic lectures, web-based training, university courses, direct mentoring, journal clubs, and required reading. Of the 159 fellows described, spanning a 5-year training period, the majority chose projects relying on their own data collection (57%) rather than joining an existing research study and focused on clinical research (86%). Among 96 fellows with completed scholarly work, 29% were observational/epidemiological studies, 22% secondary analyses of large data sets, 16% community-based research, and 15% survey design. A limited number of fellows pursued basic science, meta-analysis/critical appraisal of the literature, or analysis of public policy. Barriers to successful fellow research are as follows: lack of time and money, challenges in balancing clinical demands and protected faculty research time, limited faculty research opportunities, time or expertise, and a lack of infrastructure for fellow research mentoring. The scholarly work of fellows in DBP fellowship programs has primarily focused on clinical research using observational/epidemiological research and secondary analysis of large data set. Barriers largely in faculty time and expertise for research mentoring and inadequate funding in programs that have high clinical demands and little resources for research efforts were noted.

Animal Resource Program | Center for Cancer Research

Cancer.gov

CCR Animal Resource Program The CCR Animal Resource Program plans, develops, and coordinates laboratory animal resources for CCR’s research programs. We also provide training, imaging, and technology development in support of moving basic discoveries to the clinic. The ARP Office:

Animal Resource Program | Center for Cancer Research

Cancer.gov

CCR Animal Resource Program The CCR Animal Resource Program plans, develops, and coordinates laboratory animal resources for CCR’s research programs. We also provide training, imaging, and technology development in support of moving basic discoveries to the clinic. The ARP Manager:

Assessment Study of an Undergraduate Research Training Abroad Program

ERIC Educational Resources Information Center

Nieto-Fernandez, Fernando; Race, Kathryn; Quarless, Duncan A.

2013-01-01

The Old Westbury Neuroscience International Research Program (OWNIP) encourages undergraduate students from health disparities populations and underrepresented minorities to pursue careers in basic science, biomedical, clinical, and behavioral health research fields. To evaluate this program, several measures were used tracked through an online…

Mentoring in Clinical-Translational Research: A Study of Participants in Master's Degree Programs.

PubMed

McGinn, Aileen P; Lee, Linda S; Baez, Adriana; Zwanziger, Jack; Anderson, Karl E; Seely, Ellen W; Schoenbaum, Ellie

2015-12-01

Research projects in translational science are increasingly complex and require interdisciplinary collaborations. In the context of training translational researchers, this suggests that multiple mentors may be needed in different content areas. This study explored mentoring structure as it relates to perceived mentoring effectiveness and other characteristics of master's-level trainees in clinical-translational research training programs. A cross-sectional online survey of recent graduates of clinical research master's program was conducted. Of 73 surveys distributed, 56.2% (n = 41) complete responses were analyzed. Trainees were overwhelmingly positive about participation in their master's programs and the impact it had on their professional development. Overall the majority (≥75%) of trainees perceived they had effective mentoring in terms of developing skills needed for conducting clinical-translational research. Fewer trainees perceived effective mentoring in career development and work-life balance. In all 15 areas of mentoring effectiveness assessed, higher rates of perceived mentor effectiveness was seen among trainees with ≥2 mentors compared to those with solo mentoring (SM). In addition, trainees with ≥2 mentors perceived having effective mentoring in more mentoring aspects (median: 14.0; IQR: 12.0-15.0) than trainees with SM (median: 10.5; IQR: 8.0-14.5). Results from this survey suggest having ≥2 mentors may be beneficial in fulfilling trainee expectations for mentoring in clinical-translational training. © 2015 Wiley Periodicals, Inc.

Reminder: NCI Requests Cancer Targets for Monoclonal Antibody Production and Characterization | Office of Cancer Clinical Proteomics Research

Cancer.gov

In an effort to improve rigor and reproducibility, the National Cancer Institute (NCI) Antibody Characterization Program requests cancer-related protein targets for monoclonal antibody production and distribution to the scientific community. The program from The Office of Cancer Clinical Proteomics Research provides well-characterized

Clinical Investigator Development Program | Center for Cancer Research

Cancer.gov

The Center for Cancer Research (CCR), a division of the National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), is pleased to announce its annual call for applications for the Clinical Investigator Development Program (CIDP). This is an exciting training opportunity intended for physicians interested in dedicating

77 FR 16248 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

... Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical... Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for....D., Executive Secretary, Director of Scientific and Program Operations, Therapeutics Coordinating...

76 FR 21755 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-18

....14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds... Drive, Bethesda, MD 20892. Contact Person: Sheria Washington, Executive Secretary/Outreach Program...

Scleroderma Research Foundation

MedlinePlus

... with suspected lung hypertension. Scleroderma Patients Needed for Research Study to Evaluate Internet Self-Management Program January-2017 ... year before a standard clinical test could. Clinical Research Study for Scleroderma with Interstitial Lung Disease (lung scarring) ...

The Action Research Program: Experiential Learning in Systems-Based Practice for First-Year Medical Students.

PubMed

Ackerman, Sara L; Boscardin, Christy; Karliner, Leah; Handley, Margaret A; Cheng, Sarah; Gaither, Thomas W; Hagey, Jill; Hennein, Lauren; Malik, Faizan; Shaw, Brian; Trinidad, Norver; Zahner, Greg; Gonzales, Ralph

2016-01-01

Systems-based practice focuses on the organization, financing, and delivery of medical services. The American Association of Medical Colleges has recommended that systems-based practice be incorporated into medical schools' curricula. However, experiential learning in systems-based practice, including practical strategies to improve the quality and efficiency of clinical care, is often absent from or inconsistently included in medical education. A multidisciplinary clinician and nonclinician faculty team partnered with a cardiology outpatient clinic to design a 9-month clerkship for 1st-year medical students focused on systems-based practice, delivery of clinical care, and strategies to improve the quality and efficiency of clinical operations. The clerkship was called the Action Research Program. In 2013-2014, 8 trainees participated in educational seminars, research activities, and 9-week clinic rotations. A qualitative process and outcome evaluation drew on interviews with students, clinic staff, and supervising physicians, as well as students' detailed field notes. The Action Research Program was developed and implemented at the University of California, San Francisco, an academic medical center in the United States. All educational activities took place at the university's medical school and at the medical center's cardiology outpatient clinic. Students reported and demonstrated increased understanding of how care delivery systems work, improved clinical skills, growing confidence in interactions with patients, and appreciation for patients' experiences. Clinicians reported increased efficiency at the clinic level and improved performance and job satisfaction among medical assistants as a result of their unprecedented mentoring role with students. Some clinicians felt burdened when students shadowed them and asked questions during interactions with patients. Most student-led improvement projects were not fully implemented. The Action Research Program is a small pilot project that demonstrates an innovative pairing of experiential and didactic training in systems-based practice. Lessons learned include the need for dedicated time and faculty support for students' improvement projects, which were the least successful aspect of the program. We recommend that future projects aiming to combine clinical training and quality improvement projects designate distinct blocks of time for trainees to pursue each of these activities independently. In 2014-2015, the University of California, San Francisco School of Medicine incorporated key features of the Action Research Program into the standard curriculum, with plans to build upon this foundation in future curricular innovations.

Humanistic psychotherapy research 1990-2015: from methodological innovation to evidence-supported treatment outcomes and beyond.

PubMed

Angus, Lynne; Watson, Jeanne Cherry; Elliott, Robert; Schneider, Kirk; Timulak, Ladislav

2015-01-01

Over the past 25 years, humanistic psychotherapy (HP) researchers have actively contributed to the development and implementation of innovative practice-informed research measures and coding systems. Qualitative and quantitative research findings, including meta-analyses, support the identification of HP approaches as evidence-based treatments for a variety of psychological conditions. Implications for future psychotherapy research, training, and practice are discussed in terms of addressing the persistent disjunction between significant HP research productivity and relatively low support for HP approaches in university-based clinical training programs, funding agencies, and government-supported clinical guidelines. Finally, specific recommendations are provided to further enhance and expand the impact of HP research for clinical training programs and the development of treatment guidelines.

CCL3L1-CCR5 Genotype Improves the Assessment of AIDS Risk in HIV-1-Infected Individuals

DTIC Science & Technology

2008-09-08

J. Dolan3,4,5,6*, Sunil K. Ahuja1,2,9* 1 Veterans Administration Research Center for AIDS and HIV-1 Infection, South Texas Veterans Health Care...States of America, 3 Infectious Disease Clinical Research Program, Uniformed Services University, Bethesda, Maryland, United States of America, 4...in Translational Research . Support for the Wilford Hall Medical Center cohort was provided by the Infectious Disease Clinical Research Program (IDCRP

76 FR 55930 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged...; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate...

Urologic Oncology Branch - Training - NCI/AFUD | Center for Cancer Research

Cancer.gov

Postdoctoral Research Training Program This program is designed to train Ph.D. postdoctoral scientists in the growing field of urologic oncology. This program offers fellows the opportunity to participate in a diverse training experience that includes clinical and laboratory research on several urologic malignancies. The program provides an opportunity for selected individuals to complete a research project under the direction of a Senior Investigator in the Intramural Program of the National Cancer Institute.

The Minneapolis Heart Institute Foundation Summer Research Internship Program: the benefits of preprofessional experience for prospective physicians.

PubMed

Willenbring, Benjamin D; McKee, Katherine C; Wilson, Betsy V; Henry, Timothy D

2008-08-01

There is a distinct shortage of preprofessional opportunities for undergraduate premedical students. During the last 7 summers, the Minneapolis Heart Institute Foundation Summer Research Internship Program has exposed interested students to cardiology and clinical research. The goals of the internship program are threefold: to bring students in contact with the medical profession, to offer experiences in the various disciplines of cardiology, and to introduce students to clinical research. The success of the program can be measured by its influence on participants' academic pursuits and scholarly contributions. Of the 65 internship alumni, 52 are studying to become physicians and most of the others are in health-related fields. Interns have also contributed abstracts and manuscripts to peer-reviewed journals and presented their research at major conferences.

78 FR 68855 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds...

76 FR 70155 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds...

77 FR 61769 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

.... 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds... Programs Special Emphasis Panel; Scientific and Technical Review Board on Biomedical and Behavioral...

Improving clinical and translational research training: a qualitative evaluation of the Atlanta Clinical and Translational Science Institute KL2-mentored research scholars program

PubMed Central

Comeau, Dawn L; Escoffery, Cam; Freedman, Ariela; Ziegler, Thomas R; Blumberg, Henry M

2017-01-01

A major impediment to improving the health of communities is the lack of qualified clinical and translational research (CTR) investigators. To address this workforce shortage, the National Institutes of Health (NIH) developed mechanisms to enhance the career development of CTR physician, PhD, and other doctoral junior faculty scientists including the CTR-focused K12 program and, subsequently, the KL2-mentored CTR career development program supported through the Clinical and Translational Science Awards (CTSAs). Our evaluation explores the impact of the K12/KL2 program embedded within the Atlanta Clinical and Translational Science Institute (ACTSI), a consortium linking Emory University, Morehouse School of Medicine and the Georgia Institute of Technology. We conducted qualitative interviews with program participants to evaluate the impact of the program on career development and collected data on traditional metrics (number of grants, publications). 46 combined K12/KL2 scholars were supported between 2002 and 2016. 30 (65%) of the 46 K12/KL2 scholars are women; 24 (52%) of the trainees are minorities, including 10 (22%) scholars who are members of an underrepresented minority group. Scholars reported increased research skills, strong mentorship experiences, and positive impact on their career trajectory. Among the 43 scholars who have completed the program, 39 (91%) remain engaged in CTR and received over $89 000 000 as principal investigators on federally funded awards. The K12/KL2 funding provided the training and protected time for successful career development of CTR scientists. These data highlight the need for continued support for CTR training programs for junior faculty. PMID:27591319

Predictors of doctoral student success in professional psychology: characteristics of students, programs, and universities.

PubMed

Graham, James M; Kim, Yang-Hyang

2011-04-01

In the face of the rising number of doctoral recipients in professional psychology, many have voiced concerns about the quality of nontraditional training programs. Past research suggests that, on a variety of outcomes, graduates from clinical PhD programs outperform graduates from clinical PsyD and, to a lesser extent, counseling PhD programs. We examine an aggregate archival dataset to determine whether student or university characteristics account for the differences in outcomes among programs. The data show meaningful differences in the outcomes of clinical PhD, PsyD, and counseling PhD programs. Furthermore, graduates from research-intensive universities perform better on the psychology licensure exam and are more likely to become American Board of Professional Psychology diplomates. The available data support the notion that the ability to conduct research is an essential component of graduate education. In this light, PsyD programs represent a unique opportunity to train students in the types of evaluation and outcomes assessments used by practicing psychologists. We discuss implications for graduate-level training in professional psychology. © 2011 Wiley Periodicals, Inc.

Contributions of Academic Emergency Medicine Programs to U.S. Health Care: Summary of the AAAEM-AACEM Benchmarking Data.

PubMed

Reznek, Martin A; Scheulen, James J; Harbertson, Cathi A; Kotkowski, Kevin A; Kelen, Gabor D; Volturo, Gregory A

2018-04-01

The societal contribution of emergency care in the United States has been described. The role and impact of academic emergency departments (EDs) has been less clear. Our report summarizes the results of a benchmarking effort specifically focused on academic emergency medicine (EM) practices. From October through December 2016, the Academy of Academic Administrators of Emergency Medicine (AAAEM) and the Association of Academic Chairs of Emergency Medicine (AACEM) jointly administered a benchmarking survey to allopathic, academic departments and divisions of emergency medicine. Participation was voluntary and nonanonymous. The survey queried various aspects of the three components of the tripartite academic mission: clinical care, education and research, and faculty effort and compensation. Responses reflected a calendar year from July 1, 2015, to June 30, 2016. Of 107 eligible U.S. allopathic, academic departments and divisions of emergency medicine, 79 (74%) responded to the survey overall, although individual questions were not always answered by all responding programs. The 79 responding programs reported 6,876,189 patient visits at 97 primary and affiliated academic clinical sites. A number of clinical operations metrics related to the care of these patients at these sites are reported in this study. All responding programs had active educational programs for EM residents, with a median of 37 residents per program. Nearly half of the overall respondents reported responsibility for teaching medical students in mandatory EM clerkships. Fifty-two programs reported research and publication activity, with a total of $129,494,676 of grant funding and 3,059 publications. Median faculty effort distribution was clinical effort, 66.9%; education effort, 12.7%; administrative effort, 12.0%; and research effort, 6.9%. Median faculty salary was $277,045. Academic EM programs are characterized by significant productivity in clinical operations, education, and research. The survey results reported in this investigation provide appropriate benchmarking for academic EM programs because they allow for comparison of academic programs to each other, rather than nonacademic programs that do not necessarily share the additional missions of research and education and may have dissimilar working environments. © 2017 by the Society for Academic Emergency Medicine.

The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs

PubMed Central

Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

2011-01-01

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs. PMID:21816958

The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs.

PubMed

Kagan, Jonathan M; Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

2011-12-01

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs.

Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

ERIC Educational Resources Information Center

Wilson, Lynda Law; Rice, Marti; Jones, Carolynn T.; Joiner, Cynthia; LaBorde, Jennifer; McCall, Kimberly; Jester, Penelope M.; Carter, Sheree C.; Boone, Chrissy; Onwuzuligbo, Uzoma; Koneru, Alaya

2013-01-01

Introduction: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the…

Online Graduates in Clinical Laboratory Sciences: Are They Prepared for the Workplace?

ERIC Educational Resources Information Center

Perry, Jennifer D.

2014-01-01

Online programs are increasing in the field of clinical laboratory sciences (CLS), however there is limited research regarding how well prepared online CLS program graduates are for the workplace, given that the field is highly hands-on skills based. Prior research suggests that online CLS graduates perform as well as their traditional graduate…

AIDS--Challenges to Basic and Clinical Biomedical Research.

ERIC Educational Resources Information Center

Fauci, Anthony S.

1989-01-01

Clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. (Author/MLW)

A Novel Program Trains Community‐Academic Teams to Build Research and Partnership Capacity

PubMed Central

Brown, Jen; LeBailly, Susan; McGee, Richard; Bayldon, Barbara; Huber, Gail; Kaleba, Erin; Lowry, Kelly Walker; Martens, Joseph; Mason, Maryann; Nuñez, Abel

2013-01-01

Abstract The Community‐Engaged Research Team Support (CERTS) program was developed and tested to build research and partnership capacity for community‐engaged research (CEnR) teams. Led by the Northwestern University Clinical and Translational Sciences Institute (NUCATS), the goals of CERTS were: (1) to help community‐academic teams build capacity for conducting rigorous CEnR and (2) to support teams as they prepare federal grant proposal drafts. The program was guided by an advisory committee of community and clinical partners, and representatives from Chicago's Clinical and Translational Science Institutes. Monthly workshops guided teams to write elements of NIH‐style research proposals. Draft reviewing fostered a collaborative learning environment and helped teams develop equal partnerships. The program culminated in a mock‐proposal review. All teams clarified their research and acquired new knowledge about the preparation of NIH‐style proposals. Trust, partnership collaboration, and a structured writing strategy were assets of the CERTS approach. CERTS also uncovered gaps in resources and preparedness for teams to be competitive for federally funded grants. Areas of need include experience as principal investigators, publications on study results, mentoring, institutional infrastructure, and dedicated time for research. PMID:23751028

78 FR 6124 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-29

... Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program... Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged... Programs Special Emphasis Panel; K01 Applications. Date: February 21, 2013. Time: 8:00 a.m. to 5:00 p.m...

42 CFR 68a.12 - What will happen if an individual does not comply with the terms and conditions of participation...

Code of Federal Regulations, 2010 CFR

2010-10-01

... NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM... approved clinical research. Similarly, the research needs and priorities of the ICA and/or the NIH may... utilized in a non-clinical research assignment. Under these circumstances, the following will apply: (i...

Ongoing clinical trials of PD-1 and PD-L1 inhibitors for lung cancer in China.

PubMed

Liu, Si-Yang; Wu, Yi-Long

2017-07-05

Compared to chemotherapy, promising results have been obtained by blocking the PD-1 pathway using antibodies that inhibit programmed cell death protein 1 (PD-1) or programmed cell death protein ligand 1 (PD-L1). Furthermore, global researchers and doctors are exploring how to optimize this immunotherapy in 270 clinical studies. However, Chinese clinical trials of these agents remain in the early stages. We summarize the ongoing international and domestic clinical trials using PD-1 and PD-L1 inhibitors to treat lung cancer. This information can help researchers better understand the active and approved clinical trials in China, as well as the ongoing research regarding PD-1 and PD-L1 inhibitors.

Training the Translational Research Teams of the Future: UC Davis—HHMI Integrating Medicine into Basic Science Program

PubMed Central

Rainwater, Julie A.; Chiamvimonvat, Nipavan; Bonham, Ann C.; Robbins, John A.; Henderson, Stuart; Meyers, Frederick J.

2013-01-01

Abstract There is a need for successful models of how to recruit, train, and retain bench scientists at the earliest stages of their careers into translational research. One recent, promising model is the University of California Davis Howard Hughes Medical Institute Integrating Medicine into Basic Science (HHMI‐IMBS) program, part of the HHMI Med into Grad initiative. This paper outlines the HHMI‐IMBS program's logic, design, and curriculum that guide the goal of research that moves from bedside to bench. That is, a curriculum that provides graduate students with guided translational training, clinical exposure, team science competencies, and mentors from diverse disciplines that will advance the students careers in clinical translational research and re‐focusing of research to answer clinical dilemmas. The authors have collected data on 55 HHMI‐IMBS students to date. Many of these students are still completing their graduate work. In the current study the authors compare the initial two cohorts (15 students) with a group of 29 control students to examine the program success and outcomes. The data indicate that this training program provides an effective, adaptable model for training future translational researchers. HHMI‐IMBS students showed improved confidence in conducting translational research, greater interest in a future translational career, and higher levels of research productivity and collaborations than a comparable group of predoctoral students. PMID:24127920

Doctoral programs to train future leaders in clinical and translational science.

PubMed

Switzer, Galen E; Robinson, Georgeanna F W B; Rubio, Doris M; Fowler, Nicole R; Kapoor, Wishwa N

2013-09-01

Although the National Institutes of Health (NIH) has made extensive investments in educational programs related to clinical and translational science (CTS), there has been no systematic investigation of the number and characteristics of PhD programs providing training to future leaders in CTS. The authors undertook to determine the number of institutions that, having had received NIH-funded Clinical and Translational Science Awards (CTSAs), currently had or were developing PhD programs in CTS; to examine differences between programs developed before and after CTSA funding; and to provide detailed characteristics of new programs. In 2012, CTS program leaders at the 60 CTSA-funded institutions completed a cross-sectional survey focusing on four key domains related to PhD programs in CTS: program development and oversight; students; curriculum and research; and milestones. Twenty-two institutions had fully developed PhD programs in CTS, and 268 students were earning PhDs in this new field; 13 institutions were planning PhD programs. New programs were more likely to have fully developed PhD competencies and more likely to include students in medical school, students working only on their PhD, students working on a first doctoral degree, and students working in T1 translational research. They were less likely to include physicians and students working in clinical or T2 research. Although CTS PhD programs have similarities, they also vary in their characteristics and management of students. This may be due to diversity in translational science itself or to the relative infancy of CTS as a discipline.

Doctoral Programs to Train Future Leaders in Clinical and Translational Science

PubMed Central

Switzer, Galen E.; Robinson, Georgeanna F.W.B.; Rubio, Doris M.; Fowler, Nicole R.; Kapoor, Wishwa N.

2013-01-01

Purpose Although the National Institutes of Health (NIH) has made extensive investments in educational programs related to clinical and translational science (CTS), there has been no systematic investigation of the number and characteristics of PhD programs providing training to future leaders in CTS. The authors undertook to determine the number of institutions that, having had received NIH-funded Clinical and Translational Science Awards (CTSAs), currently had or were developing PhD programs in CTS; to examine differences between programs developed before and after CTSA funding; and to provide detailed characteristics of new programs. Method In 2012, CTS program leaders at the 60 CTSA-funded institutions completed a cross-sectional survey focusing on four key domains related to PhD programs in CTS: program development and oversight; students; curriculum and research; and milestones. Results Twenty-two institutions had fully developed PhD programs in CTS, and 268 students were earning a PhD in this new field; 13 institutions were planning a PhD program. New programs were more likely to have fully developed PhD competencies and more likely to include students in medical school, students working only on their PhD, students working on a first doctoral degree, and students working in T1 translational research. They were less likely to include physicians and students working in clinical or T2 research. Conclusions Although CTS PhD programs have similarities, they also vary in their characteristics and management of students. This may be due to diversity in translational science itself or to the relative infancy of CTS as a discipline. PMID:23899901

Conflicts of interest in translational research

PubMed Central

Parks, Malcolm R; Disis, Mary L

2004-01-01

Translational research requires a team approach to scientific inquiry and product development. Translational research teams consist of basic and clinical scientists who can be members of both academic and industrial communities. The conception, pre-clinical testing, and clinical evaluation of a diagnostic or therapeutic approach demands an intense interaction between investigators with diverse backgrounds. As the barriers between industry and academia are removed, issues of potential conflict of interest become more complex. Translational researchers must become aware of the situations which constitute conflict of interest and understand how such conflicts can impact their research programs. Finally, the translational research community must participate in the dialogue ongoing in the public and private sectors and help shape the rules that will govern conflicts that arise during the evolution of their research programs. PMID:15301694

Leading North American programs in clinical assessment research: an assessment of productivity and impact.

PubMed

Morey, Leslie C

2010-05-01

To identify doctoral programs with strong concentrations in clinical assessment, I measured productivity and impact of faculty at North American institutions with American Psychological Association accredited clinical programs. Publications, citations, and h-indexes derived from 4 top assessment journals were calculated over a 10-year period (1999-2009). I identified a total of 42 leading programs that collectively accounted for more than half of the publications and citations in these journals. I found a moderate relationship between assessment productivity and both US News & World Report program rankings as well as general productivity rankings of clinical programs reported in an earlier study.

78 FR 9709 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for... Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds... Programs Special Emphasis Panel; NIH Support for Conferences and Scientific Meetings (Parent R13/U13). Date...

The short-term and long-term impact of a brief aging research training program for medical students.

PubMed

Barron, Jeremy S; Bragg, Elizabeth; Cayea, Danelle; Durso, Samuel C; Fedarko, Neal S

2015-01-01

Summer training in aging research for medical students is a strategy for improving the pipeline of medical students into research careers in aging and clinical care of older adults. Johns Hopkins University has been offering medical students a summer experience of mentored research, research training, and clinical shadowing since 1994. Long-term outcomes of this program have not been described. The authors surveyed all 191 participants who had been in the program from 1994-2010 (60% female and 27% underrepresented minorities) and received a 65.8% (N = 125) response rate. The authors also conducted Google and other online searches to supplement study findings. Thirty-seven percent of those who have completed training are now in academic medicine, and program participants have authored or coauthored 582 manuscripts. Among survey respondents, 95.1% reported that participation in the Medical Student Training in Aging Research program increased their sensitivity to the needs of older adults. This program may help to build commitment among medical students to choose careers in aging.

The CAEP Standards and Research on Educator Preparation Programs: Linking Clinical Partnerships with Program Impact

ERIC Educational Resources Information Center

Heafner, Tina; McIntyre, Ellen; Spooner, Melba

2014-01-01

Responding to the challenge of more rigorous and outcome-oriented program evaluation criteria of the Council for the Accreditation of Educator Preparation (CAEP), authors take a critical look at the intersection of two standards: Clinical Partnerships and Practice (Standard 2) and Program Impact (Standard 4). Illustrating one aspect of a secondary…

Application to graduate psychology programs by undergraduate students of color: the impact of a research training program.

PubMed

Hall, Gordon C Nagayama; Allard, Carolyn B

2009-07-01

The top 86 students were selected from a pool of approximately 400 applicants to a summer clinical psychology research training program for undergraduate students of color. Forty-three of the students were randomly assigned to 1 of 2 clinical psychology research training programs, and 43 were randomly assigned to a control condition without training. The multicultural version of the training program emphasized the cultural context of psychology in all areas of training, whereas cultural context was de-emphasized in the monocultural version of the program. Although the cultural content of the 2 training programs was effectively manipulated as indicated by a fidelity check by an outside expert, there were no significant differences between the effects of the 2 programs on the outcomes measured in this study. The primary differences in this study were between students who did versus those who did not participate in a training program. Sixty-five percent of the students who completed the multicultural training program applied to graduate schools in psychology, compared with 47% of those who completed the monocultural training program, and 31% of those in the control group. Participation in summer research training programs also increased self-perceptions of multicultural competence.

Requests Cancer Targets for Monoclonal Antibody Production and Characterization | Office of Cancer Clinical Proteomics Research

Cancer.gov

In an effort to provide well-characterized monoclonal antibodies to the scientific community, the National Cancer Institute (NCI) Antibody Characterization Program requests cancer-related protein targets for affinity production and distribution. The program from The Office of Cancer Clinical Proteomics Research provides reagents and other critical resources that support protein and/or peptide measurements and analysis.

The Evaluation of a Clinical Development Unit Leadership Preparation Program by Focus Group Interviews--Part I: Positive Aspects. Part II: Negative Aspects.

ERIC Educational Resources Information Center

Greenwood, Jennifer; Parsons, Myra

2002-01-01

Focus group evaluations of a training program for nurses leading clinical development units focused on research-based practice found that leadership and strategic skills were developed. However, participants had insufficient time to assimilate knowledge or develop mentoring relationships and needed more help developing research-receptive culture…

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

PubMed Central

Rubio, Doris M.; Thomas, Veronica G.

2013-01-01

Abstract The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality. PMID:23919366

A Master of Science Degree in (Clinical) Pharmacology at the University of the Pacific

ERIC Educational Resources Information Center

Shirachi, Donald Y.; Jones, Judith K.

1976-01-01

A prototype program leading to a clinically-oriented Master of Science degree in pharmacology is described. It differs from a clinical residency program, does not give a wide clinical medicine exposure, and is heavily oriented towards pharmacology and research, thereby developing students with scientific perspectives who can work as consultants.…

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right

PubMed Central

Pandi-Perumal, Seithikurippu R.; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R.; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article. PMID:26042053

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right.

PubMed

Pandi-Perumal, Seithikurippu R; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK(®) of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

Syphilis

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

76 FR 3913 - National Institute on Drug Abuse; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse... individual investigators. Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns... Psychologist, Clinical Pharmacology Branch, Intramural Research Program, National Institute on Drug Abuse...

Raising suspicions with the Food and Drug Administration: detecting misconduct.

PubMed

Hamrell, Michael R

2010-12-01

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified. The inspection of a clinical study sometimes uncovers evidence of research fraud or misconduct and it must be decided how to deal with the investigator and the suspect data. The prevention of [or] decreasing the incidence of fraud and misconduct through monitoring by the sponsor is one way to manage compliance issues and can help prevent misconduct. A training program is another way to manage compliance issues in clinical research. While training does not guarantee quality, it does help to ensure that all individuals involved understand the rules and the consequences of research misconduct.

A Descriptive Study of Nursing Peer-Review Programs in US Magnet® Hospitals.

PubMed

Roberts, Holli; Cronin, Sherill Nones

2017-04-01

The goal of this study was to assess the types of nursing peer review (NPR) programs in US Magnet® organizations. The 2 most predominant models of NPR programs in the literature are performance evaluation and clinical peer review. The literature on clinical peer review is primarily descriptive, outlining structures and anecdotal outcomes. Participants from hospitals holding Magnet recognition were selected using a stratified random-sampling method. A survey developed by the researchers assessed the presence of NPR. If clinical NPR was in place, program design, evaluation measurements, and barriers were explored. Findings suggest wide variability in NPR models. More than one-third of the respondents conduct peer evaluation as the only mechanism of NPR. Most hospitals with a clinical peer-review program reported a case review structure and process measurements not supported by data. The variations noted in this study suggest more research is needed to measure the effectiveness of NPR models and associated outcomes.

The Gene Therapy Resource Program: A Decade of Dedication to Translational Research by the National Heart, Lung, and Blood Institute.

PubMed

Flotte, Terence R; Daniels, Eric; Benson, Janet; Bevett-Rose, Jeneé M; Cornetta, Kenneth; Diggins, Margaret; Johnston, Julie; Sepelak, Susan; van der Loo, Johannes C M; Wilson, James M; McDonald, Cheryl L

2017-12-01

Over a 10-year period, the Gene Therapy Resource Program (GTRP) of the National Heart Lung and Blood Institute has provided a set of core services to investigators to facilitate the clinical translation of gene therapy. These services have included a preclinical (research-grade) vector production core; current Good Manufacturing Practice clinical-grade vector cores for recombinant adeno-associated virus and lentivirus vectors; a pharmacology and toxicology core; and a coordinating center to manage program logistics and to provide regulatory and financial support to early-phase clinical trials. In addition, the GTRP has utilized a Steering Committee and a Scientific Review Board to guide overall progress and effectiveness and to evaluate individual proposals. These resources have been deployed to assist 82 investigators with 172 approved service proposals. These efforts have assisted in clinical trial implementation across a wide range of genetic, cardiac, pulmonary, and blood diseases. Program outcomes and potential future directions of the program are discussed.

An Undergraduate Research Fellowship Program to Prepare Nursing Students for Future Workforce Roles

PubMed Central

Slattery, Mary Jo; Logan, Bridget; Mudge, Bridget; Secore, Karen; Von Reyn, LInda J.; Maue, Robert A.

2016-01-01

It is important for nurses today and for those joining the workforce in the future to have familiarity and training with respect to interprofessional research, evidence-based practice, and quality improvement. In an effort to address this need, we describe a 10-week summer research program that immerses undergraduate nursing students in a broad spectrum of clinical and translational research projects as part of their exposure to advanced nursing roles. In doing so, the program increases the ability of the students to participate in research, effectively interact with academic medical center researchers, and incorporate elements of evidence-based practice into future nursing interventions. Their mentors are nurses practicing in roles as nurse researcher, advanced practice nurses involved in evidence-based practice or quality improvement, and clinical trials research nurses. Each student is matched with 3 of these mentors and involved in 3 different projects. Through this exposure, the students benefit from observing multiple nursing roles, taking an active role in research-related activities participating in interdisciplinary learning experiences. Overall, the program provides benefits to the students, who demonstrate measured improvement with respect to the program objectives, and to their mentors and each of the participating organizations. PMID:27964811

Applying Process Improvement Methods to Clinical and Translational Research: Conceptual Framework and Case Examples.

PubMed

Daudelin, Denise H; Selker, Harry P; Leslie, Laurel K

2015-12-01

There is growing appreciation that process improvement holds promise for improving quality and efficiency across the translational research continuum but frameworks for such programs are not often described. The purpose of this paper is to present a framework and case examples of a Research Process Improvement Program implemented at Tufts CTSI. To promote research process improvement, we developed online training seminars, workshops, and in-person consultation models to describe core process improvement principles and methods, demonstrate the use of improvement tools, and illustrate the application of these methods in case examples. We implemented these methods, as well as relational coordination theory, with junior researchers, pilot funding awardees, our CTRC, and CTSI resource and service providers. The program focuses on capacity building to address common process problems and quality gaps that threaten the efficient, timely and successful completion of clinical and translational studies. © 2015 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc.

Improving patient care through implementation of an antimicrobial stewardship program.

PubMed

Palmer, Hannah R; Weston, Jaye; Gentry, Layne; Salazar, Miguel; Putney, Kimberly; Frost, Craig; Tipton, Joyce A; Cottreau, Jessica; Tam, Vincent H; Garey, Kevin W

2011-11-15

The implementation of an antimicrobial stewardship program at a health system is described. In 2008, the Center for Antimicrobial Stewardship and Epidemiology (CASE) was formed at St. Luke's Episcopal Hospital (SLEH) to improve the quality of care for patients as it related to antimicrobial therapy. The charter of CASE contained specific aims for improving patient care, furthering clinical research, and training the next generation of clinical infectious diseases pharmacists. The CASE team consists of at least two infectious diseases pharmacists and one physician (the medical director) who provide direct oversight for antimicrobial utilization within the hospital. The CASE medical director, an infectious diseases physician, is responsible for overseeing the activities of the center. With the oversight of the CASE advisory board, the medical director develops and implements the antimicrobial stewardship and management policies for SLEH. Another key innovative feature of CASE is its extensive involvement in training new infectious diseases pharmacists and conducting research. CASE uses a model in which a clinical scenario or problem is identified, a research project is undertaken to further elucidate the problem, and policy changes are made to improve patient outcomes. The CASE team is supported by a CASE advisory board, a CASE research collaborative including university faculty, and a dedicated training program for pharmacy fellows, residents, and students. Implementation of an antimicrobial stewardship program at a health system helped decrease the inappropriate use of antibiotics, improve patient care and outcomes, further clinical research, and increase training opportunities for future clinical infectious diseases pharmacists.

Tickborne Diseases

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Tuberculosis (TB)

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Postdoctoral Fellow | Center for Cancer Research

Cancer.gov

The Laboratory of Tumor Immunology and Biology (LTIB) functions as a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of developing novel immunotherapies for cancer. The LTIB strategic plan focuses on the development of novel immunotherapeutics for human cancer, not only as monotherapies, but more importantly, in combination with other immune-mediating modalities, and other conventional or experimental therapies, as part of an immuno-oncology programmatic effort. Within this effort are several research groups, a clinical trials group, and multiple collaborations with intramural and extramural scientific and clinical investigators and with investigators in the private sector. The program takes advantage of the uniqueness of the NCI intramural program in that it spans high-risk basic discovery research in immunology, genomics and tumor biology, through preclinical translational research, to paradigm-shifting clinical trials. Focus is placed on the design and development of novel "off-the-shelf" recombinant immunotherapeutics that can be used in clinical studies at numerous institutions. A major strength of the program is the rapid translation of preclinical studies to hypothesis-generating clinical trials. We are looking for postdoctoral fellows interested in learning immunology and immunotherapy, as well as those postdoctoral fellows with a background and/or interest in experimental pathology.  The position is available immediately. The appointment duration is up to 5 years. Stipends are commensurate with education and experience.

Teaching Statistics in APA-Accredited Doctoral Programs in Clinical and Counseling Psychology: A Syllabi Review

ERIC Educational Resources Information Center

Ord, Anna S.; Ripley, Jennifer S.; Hook, Joshua; Erspamer, Tiffany

2016-01-01

Although statistical methods and research design are crucial areas of competency for psychologists, few studies explore how statistics are taught across doctoral programs in psychology in the United States. The present study examined 153 American Psychological Association-accredited doctoral programs in clinical and counseling psychology and aimed…

Cleveland Clinic's summer research program in reproductive medicine: an inside look at the class of 2014

PubMed Central

Durairajanayagam, Damayanthi; Kashou, Anthony H; Tatagari, Sindhuja; Vitale, Joseph; Cirenza, Caroline; Agarwal, Ashok

2015-01-01

Background The American Center for Reproductive Medicine's summer internship course in reproductive medicine and research at Cleveland Clinic is a rigorous, results-oriented annual program that began in 2008 to train both local and international students in the fundamentals of scientific research and writing. The foremost goal of the program is to encourage premedical and medical students to aspire toward a career as a physician–scientist. The internship provides participants with an opportunity to engage in original bench research and scientific writing while developing theoretical knowledge and soft skills. This study describes selected survey responses from interns who participated in the 2014 internship program. The objective of these surveys was to elicit the interns' perspective on the internship program, its strengths and weaknesses, and to obtain insight into potential areas for improvement. Methods Questionnaires were structured around the five fundamental aspects of the program: 1) theoretical knowledge, 2) bench research, 3) scientific writing, 4) mentorship, and 5) soft skills. In addition, an exit survey gathered information on factors that attracted the interns to the program, communication with mentors, and overall impression of the research program. Results The opportunity to experience hands-on bench research and scientific writing, personalized mentorship, and the reputation of the institution were appreciated and ranked highly among the interns. Nearly 90% of the interns responded that the program was beneficial and well worth the time and effort invested by both interns and faculty. Conclusion The outcomes portrayed in this study will be useful in the implementation of new programs or refinement of existing medical research training programs. PMID:26563960

77 FR 60445 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged...; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate... of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, Building 1...

77 FR 31627 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from..., Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health...

59 MDW/ST OVERVIEW BRIEFING 15 JUNE 2017

DTIC Science & Technology

2017-06-15

your department has told you they cannot fund your publication, the 59th Clinical Research Division may pay for your basic journal publishing charges...Simulation Training • Clinical Rehabilitative Medicine • Clinical Investigations Program • Dental & Nursing Research 5 \\I ••• • Science & Technology... Research and Evaluation • USAF Post Graduate Dental School and Clinics , JBSA-Lackland • Dental Evaluation and Consultation Service, JBSA-Fort Sam

Outcomes From the NIH Clinical Research Training Program: A Mentored Research Experience to Enhance Career Development of Clinician-Scientists.

PubMed

Ognibene, Frederick P; Gallin, John I; Baum, Bruce J; Wyatt, Richard G; Gottesman, Michael M

2016-12-01

Clinician-scientists are considered an endangered species for many reasons, including challenges with establishing and maintaining a career pipeline. Career outcomes from yearlong medical and dental students' research enrichment programs have not been well determined. Therefore, the authors assessed career and research outcome data from a cohort of participants in the National Institutes of Health (NIH) Clinical Research Training Program (CRTP). The CRTP provided a yearlong mentored clinical or translational research opportunity for 340 medical and dental students. Of these, 135 completed their training, including fellowships, from 1997 to January 2014. Data for 130 of 135 were analyzed: time conducting research, types of public funding (NIH grants), and publications from self-reported surveys that were verified via the NIH Research Portfolio Online Reporting Tools Web site and PubMed. Nearly two-thirds (84 of 130) indicated that they were conducting research, and over half of the 84 (approximately one-third of the total cohort) spent more than 25% of time conducting research. Of those 84, over 25% received grant support from the NIH, and those further in their careers published more scholarly manuscripts. Data suggest that the CRTP helped foster the careers of research-oriented medical and dental students as measured by time conducting research, successful competition for federal funding, and the publication of their research. Longer follow-up is warranted to assess the impact of these mentored research experiences. Investments in mentored research programs for health professional students are invaluable to support the dwindling pipeline of biomedical researchers and clinician-scientists.

76 FR 57748 - National Cancer Institute Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... Cancer Institute Special Emphasis Panel; Core Infrastructure and Methodological Research for Cancer... Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer... Panel; Community Clinical Oncology Program Research Bases (U10). Date: November 9, 2011. Time: 8:30 a.m...

Enhancing diversity in the public health research workforce: the research and mentorship program for future HIV vaccine scientists.

PubMed

Sopher, Carrie J; Adamson, Blythe Jane S; Andrasik, Michele P; Flood, Danna M; Wakefield, Steven F; Stoff, David M; Cook, Ryan S; Kublin, James G; Fuchs, Jonathan D

2015-04-01

We developed and evaluated a novel National Institutes of Health-sponsored Research and Mentorship Program for African American and Hispanic medical students embedded within the international, multisite HIV Vaccine Trials Network, and explored its impact on scientific knowledge, acquired skills, and future career plans. Scholars conducted social, behavioral, clinical, or laboratory-based research projects with HIV Vaccine Trials Network investigators over 8 to 16 weeks (track 1) or 9 to 12 months (track 2). We conducted an in-depth, mixed-methods evaluation of the first 2 cohorts (2011-2013) to identify program strengths, areas for improvement, and influence on professional development. A pre-post program assessment demonstrated increases in self-reported knowledge, professional skills, and interest in future HIV vaccine research. During in-depth interviews, scholars reported that a supportive, centrally administered program; available funding; and highly involved mentors and staff were keys to the program's early success. A multicomponent, mentored research experience that engages medical students from underrepresented communities and is organized within a clinical trials network may expand the pool of diverse public health scientists. Efforts to sustain scholar interest over time and track career trajectories are warranted.

Primary Immune Deficiency Diseases

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Wiskott-Aldrich Syndrome (WAS)

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Respiratory Syncytial Virus (RSV): Treatment

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Rocky Mountain Spotted Fever

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Programs | Office of Cancer Genomics

Cancer.gov

OCG facilitates cancer genomics research through a series of highly-focused programs. These programs generate and disseminate genomic data for use by the cancer research community. OCG programs also promote advances in technology-based infrastructure and create valuable experimental reagents and tools. OCG programs encourage collaboration by interconnecting with other genomics and cancer projects in order to accelerate translation of findings into the clinic. Below are OCG’s current, completed, and initiated programs:

Outcomes from the NIH Clinical Research Training Program: A Mentored Research Experience to Enhance Career Development of Clinician–Scientists

PubMed Central

Ognibene, Frederick P.; Gallin, John I.; Baum, Bruce J.; Wyatt, Richard G.; Gottesman, Michael M.

2017-01-01

Purpose Clinician-scientists are considered an endangered species for many reasons, including challenges with establishing and maintaining a career pipeline. Career outcomes from year-long medical and dental students’ research enrichment programs have not been well determined. Therefore, the authors assessed career and research outcome data from a cohort of participants in the National Institutes of Health (NIH) Clinical Research Training Program (CRTP). Method The CRTP provided a year-long mentored clinical or translational research opportunity for 340 medical and dental students. Of these, 135 completed their training, including fellowships, from 1997 to January 2014. Data for 130 of 135 were analyzed, including time conducting research, types of public funding (NIH grants), and publications from self-reported surveys that were verified via NIH RePORT and PUBMED. Results Nearly two-thirds (84 of 130) indicated that they were conducting research, and over half of the 84 (approximately one-third of the total cohort) spent more than 25% of time devoted to research. Of those 84, over 25% received grant support from the NIH, and those further in their careers published more scholarly manuscripts. Conclusions Data suggest that the CRTP helped foster the careers of research-oriented medical and dental students as measured by time conducting research, successful competition for federal funding, and the publication of their research. Longer follow-up is warranted to assess the impact of these mentored research experiences. Investments in mentored research programs for health professional students are invaluable to support the dwindling pipeline of biomedical researchers and clinician-scientists. PMID:27224296

Development of a Student Mentored Research Program between a Complementary and Alternative Medicine University and a Traditional, Research Intensive University

PubMed Central

Sullivan, Barbara M.; Furner, Sylvia E.; Cramer, Gregory D.

2014-01-01

The global need to develop clinician-scientists capable of using research in clinical practice, translating research knowledge into practice, and carrying out research that affects the quality, efficacy, and efficiency of health care is well-documented. The complementary and alternative medicine (CAM) professions embrace the call to develop physician-researchers to carry out translational and applied research for CAM modalities. CAM universities face unique challenges when implementing research training compared to traditional, research intensive (TRI) universities and medical centers where the majority of medical research is carried out. The authors present the development and outcomes of a mentored research program (MRP) between a CAM and a TRI institution, the National University of Health Sciences and the University of Illinois at Chicago School of Public Health, between 2006 and 2012. CAM pre-doctoral students engaged in a full-immersion semester at the TRI, including didactic courses and active research with a TRI faculty research mentor. Half of the participating doctor of chiropractic (DC) students continued on to PhD programs and half established integrative medicine, primary care clinical careers. Establishing rigorous criteria for mentors and mentees, communicating expectations, developing solid relationships between the mentor, mentee, and home school advisor, responding quickly to impediments, and providing adequate support from CAM and TRI investigators were key to the MRP success. To sustain research opportunities, coordinated degree programs for the DC and master of public health (DC/MPH) and master of clinical and translational research (DC/MS CTS) were established. PMID:24988423

Establishment of a Research Pharmacy to Support Ebola Clinical Research in Liberia

PubMed Central

Pierson, Jerome F.; Kirchoff, Matthew Carl; Tyee, Rev Tegli; Rhie, Julie K.; Montello, Michael J

2017-01-01

Objective This paper describes the establishment of a research pharmacy to support the PREVAIL vaccine study for Ebola Virus Disease. Setting This paper describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia in 2014 and 2015. Practice Innovation The need to rapidly establish infrastructure to support the Liberian-US joint clinical research partnership in response to the emerging Ebola Virus Disease provided the opportunity for collaboration among Liberian and US pharmacists. Evaluation and Results Experiences of the Liberian and US pharmacists involved in the program are described. Conclusion The partnership was successful in the conduct of the study, but more importantly, capacity for Liberian pharmacists to support clinical research was established. Additionally, the US team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. PMID:28610940

Using a Quasi-Experimental Research Design to Assess Knowledge in Continuing Medical Education Programs

ERIC Educational Resources Information Center

Markert, Ronald J.; O'Neill, Sally C.; Bhatia, Subhash C.

2003-01-01

Introduction: The objectives of continuing medical education (CME) programs include knowledge acquisition, skill development, clinical reasoning and decision making, and health care outcomes. We conducted a yearlong medical education research study in which knowledge acquisition in our CME programs was assessed. Method: A randomized…

CRC Clinical Trials Management System (CTMS): An Integrated Information Management Solution for Collaborative Clinical Research

PubMed Central

Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.

2003-01-01

The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471

Outcomes of Australian rural clinical schools: a decade of success building the rural medical workforce through the education and training continuum.

PubMed

Greenhill, Jennene A; Walker, Judi; Playford, Denese

2015-01-01

The establishment of the rural clinical schools funded through the Commonwealth Department of Health and Ageing (now Department of Health) Rural Clinical Training and Support program over a decade ago has been a significant policy initiative in Australian rural health. This article explores the impacts of this policy initiative and presents the wide range of educational innovations contextualised to each rural community they serve. This article reviews the achievements of the Australian rural clinical and regional medical schools (RCS/RMS) through semi-structured interviews with the program directors or other key informants. The questions and responses were analysed according to the funding parameters to ascertain the numbers of students, types of student placements and range of activities undertaken by each university program. Sixteen university medical schools have established 18 rural programs, creating an extensive national network of RCS and RMS in every state and territory. The findings reveal extensive positive impacts on rural and regional communities, curriculum innovation in medical education programs and community engagement activities. Teaching facilities, information technology, video-conferencing and student accommodation have brought new infrastructure to small rural towns. Rural clinicians are thriving on new opportunities for education and research. Clinicians continue to deliver clinical services and some have taken on formal academic positions, reducing professional isolation, improving the quality of care and their job satisfaction. This strategy has created many new clinical academics in rural areas, which has retained and expanded the clinical workforce. A total of 1224 students are provided with high-quality learning experiences for long-term clinical placements. These placements consist of a year or more in primary care, community and hospital settings across hundreds of rural and remote areas. Many programs offer longitudinal integrated clerkships; others offer block rotations in general practice and specialist clinics. Nine universities established programs prior to 2004, and these well-established programs are finding graduates who are returning to rural practice. Universities are required to have 25% of the students from a rural background. University admission policies have changed to encourage more applications from rural students. This aspect of the policy implements the extensive research evidence that rural-origin students are more likely to become rural practitioners. Additional capacity for research in RCS has influenced the rural health agenda in fields including epidemiology, population health, Aboriginal health, aged care, mental health and suicide prevention, farming families and climate change. There are strong research partnerships with rural workforce agencies, research centres for early career researchers and PhD students. The RCS policy initiative has vastly increased opportunities for medical students to have long-term clinical placements in rural health services. Over a decade since the policy has been implemented, graduates are being attracted to rural practice because they have positive learning experiences, good infrastructure and support within rural areas. The study shows the RCS initiative sets the stage for a sustainable future Australian rural medical workforce now requiring the development of a seamless rural clinical training pipeline linking undergraduate and postgraduate medical education.

Characteristics of research tracks in dermatology residency programs: a national survey.

PubMed

Narala, Saisindhu; Loh, Tiffany; Shinkai, Kanade; Paravar, Taraneh

2017-12-15

Pursuing research is encouraged in dermatology residency programs. Some programs offer specific research or investigative tracks. Currently, there is little data on the structure or scope of research tracks in dermatology residency programs. An anonymous online survey was distributed to the Association of Professors of Dermatology listserve in 2016. Program directors of dermatology residency programs in the United States were asked to participate and 38 of the 95 program directors responded. The survey results confirmed that a 2+2 research track, which is two years of clinical training followed by two years of research, was the most common investigator trackmodel and may promote an academic career at the resident's home institution. Further studies will help determine the most effective research track models to promote long-term outcomes.

A CTSA Agenda to Advance Methods for Comparative Effectiveness Research

PubMed Central

Helfand, Mark; Tunis, Sean; Whitlock, Evelyn P.; Pauker, Stephen G.; Basu, Anirban; Chilingerian, Jon; Harrell Jr., Frank E.; Meltzer, David O.; Montori, Victor M.; Shepard, Donald S.; Kent, David M.

2011-01-01

Abstract Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient‐centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness research (CER) fundamentally patient‐centered, challenge researchers to adopt or develop methods that improve the timeliness, relevance, and practical application of clinical studies. In this paper, we describe 10 priority areas that address 3 critical needs for research on patient‐centered outcomes (PCOR): (1) developing and testing trustworthy methods to identify and prioritize important questions for research; (2) improving the design, conduct, and analysis of clinical research studies; and (3) linking the process and outcomes of actual practice to priorities for research on patient‐centered outcomes. We argue that the National Institutes of Health, through its clinical and translational research program, should accelerate the development and refinement of methods for CER by linking a program of methods research to the broader portfolio of large, prospective clinical and health system studies it supports. Insights generated by this work should be of enormous value to PCORI and to the broad range of organizations that will be funding and implementing CER. Clin Trans Sci 2011; Volume 4: 188–198 PMID:21707950

Assessing Competencies in a Master of Science in Clinical Research Program: The Comprehensive Competency Review.

PubMed

Robinson, Georgeanna F W B; Moore, Charity G; McTigue, Kathleen M; Rubio, Doris M; Kapoor, Wishwa N

2015-12-01

Competencies in Master of Science Clinical Research programs are becoming increasingly common. However, students and programs can only benefit fully from competency-based education if students' competence is formally assessed. Prior to a summative assessment, students must have at least one formative, formal assessment to be sure they are developing competence appropriate for their stage of training. This paper describes the comprehensive competency review (CCR), a milestone for MS students in Clinical Research at the University of Pittsburgh's Institute for Clinical Research Education. The CCR involves metacognitive reflection of the student's learning as a whole, written evidence of each competency, a narrative explaining the choice of evidence for demonstrating competencies, and a meeting in which two faculty members review the evidence and solicit further oral evidence of competence. CCRs allow for individualized feedback at the midpoint in degree programs, providing students with confidence that they will have the means and strategies to develop competence in all areas by the summative assessment of competence at their thesis defense. CCRs have also provided programmatic insight on the need for curricular revisions and additions. These benefits outweigh the time cost on the part of students and faculty in the CCR process. © 2015 Wiley Periodicals, Inc.

Assessing Competencies in a Master of Science in Clinical Research Program: The Comprehensive Competency Review

PubMed Central

Moore, Charity G.; McTigue, Kathleen M.; Rubio, Doris M.; Kapoor, Wishwa N.

2015-01-01

Abstract Competencies in Master of Science Clinical Research programs are becoming increasingly common. However, students and programs can only benefit fully from competency‐based education if students’ competence is formally assessed. Prior to a summative assessment, students must have at least one formative, formal assessment to be sure they are developing competence appropriate for their stage of training. This paper describes the comprehensive competency review (CCR), a milestone for MS students in Clinical Research at the University of Pittsburgh's Institute for Clinical Research Education. The CCR involves metacognitive reflection of the student's learning as a whole, written evidence of each competency, a narrative explaining the choice of evidence for demonstrating competencies, and a meeting in which two faculty members review the evidence and solicit further oral evidence of competence. CCRs allow for individualized feedback at the midpoint in degree programs, providing students with confidence that they will have the means and strategies to develop competence in all areas by the summative assessment of competence at their thesis defense. CCRs have also provided programmatic insight on the need for curricular revisions and additions. These benefits outweigh the time cost on the part of students and faculty in the CCR process. PMID:26332763

77 FR 62518 - Proposed Collection; Comment Request: Recipient Epidemiology and Donor Evaluation Study-III (REDS...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

..., translational, and clinical research to improve the benefits of transfusion while reducing its risks. The... Institute (NHLBI) REDS programs have proven to be the premier research programs in blood collection and... successes that this research network has realized over the years while being responsive to changing research...

About the Lung and Upper Aerodigestive Cancer Research Group | Division of Cancer Prevention

Cancer.gov

The Lung and Upper Aerodigestive Cancer Research Group conducts and supports research on the prevention and early detection of lung and head and neck cancers, as well as new approaches to clinical prevention studies including cancer immunoprevention.Phase 0/I/II Cancer Prevention Clinical Trials ProgramThe group jointly administers the Phase 0/I/II Cancer Prevention Clinical

Exercise and Fall Prevention: Narrowing the Research-to-Practice Gap and Enhancing Integration of Clinical and Community Practice.

PubMed

Li, Fuzhong; Eckstrom, Elizabeth; Harmer, Peter; Fitzgerald, Kathleen; Voit, Jan; Cameron, Kathleen A

2016-02-01

Falls in older adults are a global public health crisis, but mounting evidence from randomized controlled trials shows that falls can be reduced through exercise. Public health authorities and healthcare professionals endorse the use of evidence-based, exercise-focused fall interventions, but there are major obstacles to translating and disseminating research findings into healthcare practice, including lack of evidence of the transferability of efficacy trial results to clinical and community settings, insufficient local expertise to roll out community exercise programs, and inadequate infrastructure to integrate evidence-based programs into clinical and community practice. The practical solutions highlighted in this article can be used to address these evidence-to-practice challenges. Falls and their associated healthcare costs can be reduced by better integrating research on exercise intervention into clinical practice and community programs. © 2016 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

Analyzing the effectiveness of teaching and factors in clinical decision-making.

PubMed

Hsieh, Ming-Chen; Lee, Ming-Shinn; Chen, Tsung-Ying; Tsai, Tsuen-Chiuan; Pai, Yi-Fong; Sheu, Min-Muh

2017-01-01

The aim of this study is to prepare junior physicians, clinical education should focus on the teaching of clinical decision-making. This research is designed to explore teaching of clinical decision-making and to analyze the benefits of an "Analogy guide clinical decision-making" as a learning intervention for junior doctors. This study had a "quasi-experimental design" and was conducted in a medical center in eastern Taiwan. Participants and Program Description: Thirty junior doctors and three clinical teachers were involved in the study. The experimental group (15) received 1 h of instruction from the "Analogy guide for teaching clinical decision-making" every day for 3 months. Program Evaluation: A "Clinical decision-making self-evaluation form" was used as the assessment tool to evaluate participant learning efficiency before and after the teaching program. Semi-structured qualitative research interviews were also conducted. We found using the analogy guide for teaching clinical decision-making could help enhance junior doctors' self-confidence. Important factors influencing clinical decision-making included workload, decision-making, and past experience. Clinical teaching using the analogy guide for clinical decision-making may be a helpful tool for training and can contribute to a more comprehensive understanding of decision-making.

Sarilumab for the treatment of rheumatoid arthritis.

PubMed

Cooper, Simon

2016-01-01

Simon Cooper has >18 years of global experience in the pharmaceutical industry. He joined Sanofi in July 2014 as the Vice President, Global Project Head. In his current position at Sanofi, Dr Cooper is responsible for the clinical development of sarilumab and the worldwide submission in rheumatoid arthritis. He joined Sanofi after serving as the Global Program Medical Director at Novartis since 2012. In this role, Dr Cooper acted as the clinical lead for secukinumab psoriasis submission. Prior to Novartis, Dr Cooper held various posts at Human Genome Sciences, USA, including Executive Director of Clinical Research, Senior Director of Clinical Research and Director of Clinical Research. During his tenure at Human Genome Sciences, USA, Dr Cooper was involved in the submission of belimumab leading to its approval for SLE, and was responsible for its subsequent clinical development program. Dr Cooper has also previously held positions at MedImmune Ltd, UK, Roche, Napp Pharmaceutical Research Ltd, Wyeth Research and Medeval Ltd. In these roles, his responsibilities ranged from medical oversight of clinical trials to medical support for commercial, medical affairs and business development. He received a Bachelor of Medicine and Bachelor of Surgery from University of Newcastle upon Tyne Medical School.

77 FR 73665 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research. Type of... Information Collection: This study will assess the value of the training programs administered by the Office of Clinical Research Training and Medical Education. The primary objective of the survey is to...

The importance of clinical research skills according to PharmD students, first-year residents, and residency directors.

PubMed

Anderson, Heather D; Saseen, Joseph J

Research has a prominent role within the field of pharmacy practice. However, no studies have assessed the importance of research methods in pharmacy education from the perspective of students, residents, or residency directors. Questionnaires were administered online in spring 2014 to four respondent groups: University of Colorado fourth year PharmD (P4) students, post graduate year 1 (PGY1) residents, and PGY1 and post-graduate year 2 (PGY2) residency directors. Descriptive statistics were used to characterize respondents; t-tests and chi-square tests were used to compare groups of respondents. Respondents included 255 PGY1 residency directors, 155 PGY2 residency directors, 35 PGY1 residents, and 87 P4 students. Response rates ranged from 26% (residency directors) to nearly 60% (P4 students and PGY1 residents). PGY1 residents and PGY1/PGY2 residency directors ranked research experience lowest among ten characteristics with respect to their importance when competing for a residency or being a successful resident. Among six specific clinical research skills, PGY1 residents and PGY1/PGY2 residency directors ranked "identifying and writing a research question" as the most important for successfully completing a residency research project or when selecting a PGY1/PGY2 resident. Perceived importance of clinical research skills by P4 students, current residents, and residency program directors is low. This is in opposition to opinions from several national organizations that proclaim the importance of clinical research skills in doctor of pharmacy curricula. Pharmacy programs must continue to further develop clinical research skills and abilities of future graduates while being cognizant of these perception barriers when developing strategies to enhance research experiences within their curricular programs. Copyright © 2017 Elsevier Inc. All rights reserved.

National Institute of Allergy and Infectious Diseases

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome (WHIMS)

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Types of HIV/AIDS Antiretroviral Drugs

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Mass media approaches to reducing cardiovascular disease risk.

PubMed Central

Bellicha, T; McGrath, J

1990-01-01

A key function of a basic and clinical biomedical research organization is to communicate the findings of clinical investigations so that people may apply the results to improve their health and well-being. To help communicate results from cardiovascular disease research, the National Heart, Lung, and Blood Institute has established a series of national health education programs. The authors describe a model for two of the five programs and discuss the role of communication media in supporting national goals for education programs. The research basis for the programs is reviewed, together with the process by which the Institute develops information materials for mass media, notably public service announcements. A description of two national health education campaigns, hypertension and cholesterol, illustrates how market research is used to identify appropriate target audiences, develop messages, and select channels of communication. Lessons learned about the role of mass media in a national health education campaign are summarized. PMID:2113682

EDUCATIONAL CASE REPORTS

PubMed Central

Ackerman, Sara L.; Boscardin, Christy; Karliner, Leah; Handley, Margaret A.; Cheng, Sarah; Gaither, Tom; Hagey, Jill; Hennein, Lauren; Malik, Faizan; Shaw, Brian; Trinidad, Norver; Zahner, Greg; Gonzales, Ralph

2016-01-01

Problem Systems-based practice focuses on the organization, financing, and delivery of medical services. The American Association of Medical Colleges has recommended that systems-based practice be incorporated into medical schools’ curricula. However, experiential learning in systems-based practice, including practical strategies to improve the quality and efficiency of clinical care, is often absent from or inconsistently included in medical education. Intervention A multidisciplinary clinician and non-clinician faculty team partnered with a cardiology outpatient clinic to design a nine-month clerkship for first-year medical students focused on systems-based practice, delivery of clinical care, and strategies to improve the quality and efficiency of clinical operations. The clerkship was called the Action Research Program. In 2013–2014, eight trainees participated in educational seminars, research activities, and nine-week clinic rotations. A qualitative process and outcome evaluation drew on interviews with students, clinic staff, and supervising physicians, as well as students’ detailed field notes. Context The Action Research Program was developed and implemented at the University of California, San Francisco, an academic medical center in the U.S. All educational activities took place at the university’s medical school and at the medical center’s cardiology outpatient clinic. Outcome Students reported and demonstrated increased understanding of how care delivery systems work, improved clinical skills, growing confidence in interactions with patients, and appreciation for patients’ experiences. Clinicians reported increased efficiency at the clinic level and improved performance and job satisfaction among medical assistants as a result of their unprecedented mentoring role with students. Some clinicians felt burdened when students shadowed them and asked questions during interactions with patients. Most student-led improvement projects were not fully implemented. Lessons Learned The Action Research Program is a small pilot project that demonstrates an innovative pairing of experiential and didactic training in systems-based practice. Lessons learned include the need for dedicated time and faculty support for students’ improvement projects, which were the least successful aspect of the program. We recommend that future projects aiming to combine clinical training and quality improvement projects designate distinct blocks of time for trainees to pursue each of these activities independently. In 2014–2015, the University of California, San Francisco School of Medicine incorporated key features of the Action Research Program into the standard curriculum, with plans to build upon this foundation in future curricular innovations. PMID:27064720

Current status of clinical education in paramedic programs: a descriptive research project.

PubMed

Grubbs, K C

1997-01-01

Development of competence in exercising therapeutic judgment skills represents the goal of clinical education. Time (clock hours) is not a valid predictor of attainment of competence in paramedic clinical education. Quantity of patient contact experiences facilitates development of judgment skills, and offers a valid measure of progress toward competence. This project uses national survey data from accredited programs to describe the availability and accessibility of patient contact experiences within paramedic clinical education. Data from this local program supplements the national survey results. The components of clinical judgment are enumerated, and strategies to teach and evaluate clinical judgment skills are discussed.

Structure of NCI Cooperative Groups Program Prior to NCTN

Cancer.gov

Learn how the National Cancer Institute’s Cooperative Groups Program was structured prior to its being replaced by NCI’s National Clinical Trials Network (NCTN). The NCTN gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Implementation of a new advanced graduate education program in oral implantology.

PubMed

Gallucci, German O; Weber, Hans Peter; Kalenderian, Elsbeth

2012-10-01

The academic program for the Harvard School of Dental Medicine's Advanced Graduate Program in Oral Implantology is based on scientific evidence applied to educational quality, translational research, patient care, and service. The objective of the program is to enable highly motivated individuals with proven scholarship and excellence in patient care to achieve academic leadership in the clinical and scientific fields of implant dentistry and tissue regeneration. A detailed curriculum describing the academic program, as well as a business plan (which included a management plan describing the organizational structure, financial implications, and market forces) and implementation and communication plans, were developed before moving forward. With careful academic and business planning, the result was a vibrant implant program, in which all placements and restorations of implants are coordinated with regard to practice management. The program is integrated into the existing clinical care model and has been financially self-sustaining from its inception. Six students have participated in the last two years. On average, each student performed seventy-nine procedures on twenty-nine patients, generating over $46,000 in production. The curriculum includes didactics, hands-on clinical learning, and research activities. Research is a critical component as well. The results demonstrate that the time taken to develop a detailed curriculum and business plan for a new academic program, which anticipated and resolved potential barriers to success, was instrumental in the successful implementation of an oral implantology residency program.

Combat Wound Initiative program.

PubMed

Stojadinovic, Alexander; Elster, Eric; Potter, Benjamin K; Davis, Thomas A; Tadaki, Doug K; Brown, Trevor S; Ahlers, Stephen; Attinger, Christopher E; Andersen, Romney C; Burris, David; Centeno, Jose; Champion, Hunter; Crumbley, David R; Denobile, John; Duga, Michael; Dunne, James R; Eberhardt, John; Ennis, William J; Forsberg, Jonathan A; Hawksworth, Jason; Helling, Thomas S; Lazarus, Gerald S; Milner, Stephen M; Mullick, Florabel G; Owner, Christopher R; Pasquina, Paul F; Patel, Chirag R; Peoples, George E; Nissan, Aviram; Ring, Michael; Sandberg, Glenn D; Schaden, Wolfgang; Schultz, Gregory S; Scofield, Tom; Shawen, Scott B; Sheppard, Forest R; Stannard, James P; Weina, Peter J; Zenilman, Jonathan M

2010-07-01

The Combat Wound Initiative (CWI) program is a collaborative, multidisciplinary, and interservice public-private partnership that provides personalized, state-of-the-art, and complex wound care via targeted clinical and translational research. The CWI uses a bench-to-bedside approach to translational research, including the rapid development of a human extracorporeal shock wave therapy (ESWT) study in complex wounds after establishing the potential efficacy, biologic mechanisms, and safety of this treatment modality in a murine model. Additional clinical trials include the prospective use of clinical data, serum and wound biomarkers, and wound gene expression profiles to predict wound healing/failure and additional clinical patient outcomes following combat-related trauma. These clinical research data are analyzed using machine-based learning algorithms to develop predictive treatment models to guide clinical decision-making. Future CWI directions include additional clinical trials and study centers and the refinement and deployment of our genetically driven, personalized medicine initiative to provide patient-specific care across multiple medical disciplines, with an emphasis on combat casualty care.

Yoga for Youth in Pain

PubMed Central

Evans, Subhadra; Moieni, Mona; Sternlieb, Beth; Tsao, Jennie C.I; Zeltzer, Lonnie K.

2012-01-01

Children, adolescents, and young adults do not typically feature in clinics, studies, and mainstream notions of chronic pain. Yet many young people experience debilitating pain for extended periods of time. Chronic pain in these formative years may be especially important to treat in order for young patients to maintain life tasks and to prevent protracted disability. The Pediatric Pain Program at the University of California, Los Angeles, is a multidisciplinary treatment program designed for young people with chronic pain and their families. We offer both conventional and complementary medicine to treat the whole individual. This article describes the work undertaken in the clinic and our newly developed Yoga for Youth Research Program. The clinical and research programs fill a critical need to provide service to youth with chronic pain and to scientifically study one of the more popular complementary treatments we offer, Iyengar yoga. PMID:22864296

Data protection in biomaterial banks for Parkinson's disease research: the model of GEPARD (Gene Bank Parkinson's Disease Germany).

PubMed

Eggert, Karla; Wüllner, Ullrich; Antony, Gisela; Gasser, Thomas; Janetzky, Bernd; Klein, Christine; Schöls, Ludger; Oertel, Wolfgang

2007-04-15

Parkinson's disease (PD) is the second most common neurodegenerative disease. Although 10 gene loci have been identified to cause a Parkinsonian syndrome, these loci account only for a minority of PD patients. Large, systematic research programs are required to collect, store, and analyze DNA samples and clinical information to support further discovery of additional genetic components of PD or other movement disorders. Such programs facilitate research into the relationship between genotype and phenotype. The German Competence Network on Parkinson's disease (CNP) initiated the Gene Bank Parkinson's Disease Germany (GEPARD), providing an administrative and scientific infrastructure for the storage of DNA and clinical data that are electronically accessible and protective of patient rights. In this article, we offer guidance on how to establish a framework for a clinical genetic data and DNA bank, and describe GEPARD as a model that may be useful to other local, national, and international research groups developing similar programs.

78 FR 61377 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-03

...; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93... clearly unwarranted invasion of personal privacy. Name of Committee: Office of Research Infrastructure Programs Special Emphasis Panel; Biomedical Research Conference Review. Date: October 22, 2013. Time: 3:00...

Effective Prototype Costing Policies in Research Universities: Are They Possible?

ERIC Educational Resources Information Center

McClure, Maureen W.; Abu-Duhou, Ibtisam

Policy problems of prototype costing at research universities are discussed, based on a case study of a clinical treatment prototype program at a research university hospital. Prototypes programs generate reproducible knowledge with useful applications and are primarily developed in professional schools. The potential of using costing prototypes…

Development of an interprofessional program for cardiovascular prevention in primary care: A participatory research approach

PubMed Central

Goudreau, Johanne; Hudon, Éveline; Lussier, Marie-Thérèse; Bareil, Céline; Duhamel, Fabie; Lévesque, Lise; Turcotte, Alain; Lalonde, Gilles

2014-01-01

Background: The chronic care model provides a framework for improving the management of chronic diseases. Participatory research could be useful in developing a chronic care model–based program of interventions, but no one has as yet offered a description of precisely how to apply the approach. Objectives: An innovative, structured, multi-step participatory process was applied to select and develop (1) chronic care model–based interventions program to improve cardiovascular disease prevention that can be adapted to a particular regional context and (2) a set of indicators to monitor its implementation. Methods: Primary care clinicians (n = 16), administrative staff (n = 2), patients and family members (n = 4), decision makers (n = 5), researchers, and a research coordinator (n = 7) took part in the process. Additional primary care actors (n = 26) validated the program. Results: The program targets multimorbid patients at high or moderate risk of cardiovascular disease with uncontrolled hypertension, dyslipidemia or diabetes. It comprises interprofessional follow-up coordinated by case-management nurses, in which motivated patients are referred in a timely fashion to appropriate clinical and community resources. The program is supported by clinical tools and includes training in motivational interviewing. A set of 89 process and clinical indicators were defined. Conclusion: Through a participatory process, a contextualized interventions program to optimize cardiovascular disease prevention and a set of quality indicators to monitor its implementation were developed. Similar approach might be used to develop other health programs in primary care if program developers are open to building on community strengths and priorities. PMID:26770705

Estimating Return on Investment in Translational Research: Methods and Protocols

PubMed Central

Trochim, William; Dilts, David M.; Kirk, Rosalind

2014-01-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health and its Clinical and Translational Awards (CTSA). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This paper provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities. PMID:23925706

Estimating return on investment in translational research: methods and protocols.

PubMed

Grazier, Kyle L; Trochim, William M; Dilts, David M; Kirk, Rosalind

2013-12-01

Assessing the value of clinical and translational research funding on accelerating the translation of scientific knowledge is a fundamental issue faced by the National Institutes of Health (NIH) and its Clinical and Translational Awards (CTSAs). To address this issue, the authors propose a model for measuring the return on investment (ROI) of one key CTSA program, the clinical research unit (CRU). By estimating the economic and social inputs and outputs of this program, this model produces multiple levels of ROI: investigator, program, and institutional estimates. A methodology, or evaluation protocol, is proposed to assess the value of this CTSA function, with specific objectives, methods, descriptions of the data to be collected, and how data are to be filtered, analyzed, and evaluated. This article provides an approach CTSAs could use to assess the economic and social returns on NIH and institutional investments in these critical activities.

Innovation in organ transplantation: A meeting report.

PubMed

Fishman, Jay A; Greenwald, Melissa

2018-05-09

This workshop targeted opportunities to stimulate transformative innovation in organ transplantation. Participants reached consensus regarding the following: (1) Mechanisms are needed to improve the coordination of policy and oversight activities, given overlapping responsibilities for transplantation and clinical investigation among federal agencies. Innovative clinical trials span traditional administrative boundaries and include stakeholders with diverse interests. Participants identified the need for a governmental interagency working group to coordinate nationwide transplant-related activities. (2) Improvements are required in clinical metrics for transplantation, with alignment of performance goals across transplantation organizations and any development of data requirements being consistent with those goals. Database coordination among clinical centers, organ procurement organizations, regulatory agencies, and payers would facilitate research and better inform policy. New data requirements should provide actionable insights into clinical performance. (3) Innovative research seen as potentially adversely affecting Program-Specific Reports may reduce centers' participation. Cutting-edge research requires mitigation of risk-aversive behaviors created by reporting of clinical outcomes data. Participants proposed a new review process in advance of implementation of clinical trials to guide "carve-outs" of transplant center outcomes data from Program-Specific Reports. Clinical transplantation will be advanced by the development of a shared and comprehensive research agenda to facilitate coordination of research and policy. © 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.

Hyper-Immunoglobulin E Syndrome (HIES) or Job's Syndrome

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Incubating the research independence of a medical scientist training program graduate: a case study.

PubMed

Dzirasa, Kafui; Krishnan, Ranga R; Williams, R Sanders

2015-02-01

Physician-scientists play a critical role in discovering new biological knowledge and translating findings into medical practices that can improve clinical outcomes. Collectively, the National Institutes of Health (NIH) and its affiliated Medical Scientist Training Programs (MSTPs) invest upwards of $500,000 to fully train each of the 900+ MD/PhD students enrolled in these programs. Nevertheless, graduates face the challenges of navigating fragmented intervals of clinical training and research engagement, reinitiating research upon completing their residencies, managing financial pressures, and competing for funding following what is typically four or more years of research inactivity. Together, these barriers contribute to the high attrition rate of MSTP graduates from research careers. The authors designed and implemented (2009-2014), for a single trainee, an alternative postgraduate training model characterized by early research engagement, strategic mentoring, unyoked clinical and research milestones, and dedicated financial support. The pilot training experiment was so successful that the trainee secured an NIH project grant and completed his transition to research independence 3.5 years after starting the experimental training schedule-nearly 9 years earlier (based on age) than is typical for MD/PhDs transitioning from mentored to independent research. This success has demonstrated that unyoking research engagement from conventional calendar-based clinical training milestones is a feasible, effective means of incubating research independence in MSTP graduates. The authors encourage the design and application of similar unconventional approaches that interweave residency training with ongoing research activity for appropriate candidates, especially in subspecialties with increased MSTP graduate enrollment.

Evidence-Based Practices, Attitudes, and Beliefs in Substance Abuse Treatment Programs Serving American Indians and Alaska Natives: A Qualitative Study

PubMed Central

Larios, Sandra E.; Wright, Serena; Jernstrom, Amanda; Lebron, Dorothy; Sorensen, James L.

2012-01-01

Substance abuse disproportionately impacts American Indian/Alaska Native (AI/AN) communities in the United States. For the increasing numbers of AI/AN individuals who enter and receive treatment for their alcohol or other drug problem it is imperative that the service they receive be effective. This study used qualitative methodology to examine attitudes toward evidence-based practices, also known as evidence-based treatments (EBTs) in minority-serving substance abuse treatment programs in the San Francisco Bay area. Twenty-two interviews were conducted in the study, of which seven were with program directors and substance abuse counselors at two urban AI/AN focused sites. These clinics were more likely than other minority-focused programs to have experience with research and knowledge about adapting EBTs. Only in the AI/AN specific sites did an issue arise concerning visibility, that is, undercounting AI/AN people in national and state databases. Similar to other minority-focused programs, these clinics described mistrust, fear of exploitation from the research community, and negative attitudes towards EBTs. The underutilization of EBTs in substance abuse programs is prevalent and detrimental to the health of patients who would benefit from their use. Future research should explore how to use this research involvement and experience with adaptation to increase the adoption of EBTs in AI/AN serving clinics. PMID:22400469

Call for Applications – Clinical Assay Development Program | Office of Cancer Clinical Proteomics Research

Cancer.gov

The NCI Clinical Assay Development Program (CADP) is requesting project applications from investigators seeking clinical assay validation resources.  These resources are designed to assist with the development of assays that may predict therapy response or prognostic behavior of a diagnosed cancer, primarily for use in clinical trials. Approved projects for the NCI CADP will be provided access to the Institute’s assay development and validation resources, including project management support.

Ten years of the Immune Tolerance Network: an integrated clinical research organization.

PubMed

Bluestone, Jeffrey A; Krensky, Alan M; Turka, Laurence A; Rotrosen, Daniel; Matthews, Jeffrey B

2010-02-17

The U.S. National Institutes of Health Roadmap and the U.S. Food and Drug Administration's Critical Path Initiative have endorsed the establishment of large academic clinical research networks as part of the solution to the growing divide between increased R&D spending and the lagging number of new drugs making it to market. Clearly, the role of these networks as translational science incubators that complement industry-sponsored programs is laudable and much-needed. However, the path to success for such organizations is less clear. Here, drawing on the experiences of the Immune Tolerance Network, a multidisciplinary clinical research network founded in 1999, we discuss some of the barriers inherent in developing such consortia and offer firsthand insight into the planning, resources, and organizational infrastructure required for a successful research program.

Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study

PubMed Central

Voepel-Lewis, Terri; McGonegal, Maureen; Levine, Robert

2011-01-01

Standard written methods of presenting research information may be difficult for many parents and children to understand. This pilot study was designed to examine the use of a novel prototype interactive consent program for describing a hypothetical pediatric asthma trial to parents and children. Parents and children were interviewed to examine their baseline understanding of key elements of a clinical trial, eg, randomization, placebo, and blinding. Subjects then reviewed age-appropriate versions of an interactive computer program describing an asthma trial, and their understanding of key research concepts was again tested along with their understanding of the details of the trial. Parents and children also completed surveys to examine their perceptions and satisfaction with the program. Both parents and children demonstrated improved understanding of key research concepts following administration of the consent program. For example, the percentage of parents and children who could correctly define the terms clinical trials and placebo improved from 60% to 80%, and 80% to 100% among parents and 25% to 50% and 0% to 50% among children, respectively, following review of the interactive programs. Parents and children's overall understanding of the details of the asthma trial were 14.2±0.84 and 9.25±4.9 (0–15 scale, where 15 is complete understanding), respectively. Results also suggest that the interactive programs were easy to use and facilitated understanding of the clinical trial among parents and children. Interactive media may offer an effective means of presenting understandable information to parents and children regarding participation in clinical trials. Further work to examine this novel approach appears warranted. PMID:21803924

National Institutes of Health eliminates funding for national architecture linking primary care research.

PubMed

Peterson, Kevin A

2007-01-01

With the ending of the National Electronic Clinical Trial and Research Network (NECTAR) pilot programs and the abridgement of Clinical Research Associate initiative, the National Institutes of Health Roadmap presents a strategic shift for practice-based research networks from direct funding of a harmonized national infrastructure of cooperating research networks to a model of local engagement of primary care clinics performing practice-based research under the aegis of regional academic health centers through Clinical and Translational Science Awards. Although this may present important opportunities for partnering between community practices and large health centers, for primary care researchers, the promise of a transformational change that brings a unified national primary care community into the clinical research enterprise seems likely to remain unfulfilled.

About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

Cancer.gov

The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

MO-DE-BRA-03: The Ottawa Medical Physics Institute (OMPI): A Practical Model for Academic Program Collaboration in a Multi-Centre City

DOE Office of Scientific and Technical Information (OSTI.GOV)

McEwen, M; Rogers, D; Johns, P

Purpose: To build a world-class medical physics educational program that capitalizes on expertise distributed over several clinical, government, and academic centres. Few if any of these centres would have the critical mass to solely resource a program. Methods: In order to enable an academic program, stakeholders from five institutions made a proposal to Carleton University for a) a research network with defined membership requirements and a process for accepting new members, and b) a graduate specialization (MSc and PhD) in medical physics. Both proposals were accepted and the program has grown steadily. Our courses are taught by medical physicists frommore » across the collaboration. Our students have access to physicists in: clinical radiotherapy (the Ottawa Cancer Centre treats 4500 new patients/y), radiology, cardiology and nuclear medicine, Canada’s primary standards dosimetry laboratory, radiobiology, and university-based medical physics research. Our graduate courses emphasize the foundational physics plus applied aspects of imaging, radiotherapy, and radiobiology. Active researchers in the city-wide volunteer-run network are appointed as adjunct professors by Physics, giving them access to national funding competitions and partial student funding through teaching assistantships while opening up facilities in their institutions for student thesis research. Results: The medical physics network has grown to ∼40 members from eight institutions and includes five full-time faculty in Physics and 17 adjunct research professors. The graduate student population is ∼20. Our graduates have proceeded to a spectrum of careers. Our alumni list includes a CCPM Past-President, the current COMP President, many clinical physicists, and the heads of at least three major clinical medical physics departments. Our PhD was Ontario’s first CAMPEP-accredited program. Conclusion: A self-governing volunteer network is the foundational element that enables an MSc/PhD medical physics program in a city with multiple physicist employers. It enriches graduate education with an unusually broad range of expertise.« less

How can we improve clinical research in pneumonia?

PubMed

Ramirez, Julio A

2018-05-01

The primary challenges in the field of clinical research include a lack of support within existing infrastructure, insufficient number of clinical research training programs and a paucity of qualified mentors. Most medical centers offer infrastructure support for investigators working with industry sponsors or government-funded clinical trials, yet there are a significant amount of clinical studies performed in the field of pneumonia which are observational studies. For this type of research, which is frequently unfunded, support is usually lacking. In an attempt to optimize clinical research in pneumonia, at the University of Louisville, we developed a clinical research coordinating center (CRCC). The center manages clinical studies in the field of respiratory infections, with the primary focus being pneumonia. Other activities of the CRCC include the organization of an annual clinical research training course for physicians and other healthcare workers, and the facilitation of international research mentoring by a process of connecting new pneumonia investigators with established clinical investigators. To improve clinical research in pneumonia, institutions need to have the appropriate infrastructure in place to support investigators in all aspects of the clinical research process.

Measuring Perceived Educational Impact of a Resident-Led Research Newsletter.

PubMed

Aftab, Awais; Lackamp, Jeanne; Cerny, Cathleen

2017-06-01

To determine the perceived educational impact of a resident-led psychiatry research newsletter ('Research Watch') on the psychiatry residents at the authors' residency program. An anonymous, voluntary paper questionnaire was distributed to all psychiatry residents at the program. The survey inquired about the degree of exposure (quantified as 'exposure index') and contribution to the newsletter. A set of questions asked residents to estimate how much of the improvement they attributed to the influence of the newsletter, rating the attribution between 0 and 100%, in the areas of interest in scholarly activities/research, knowledge of current psychiatric research, and participation in scholarly activities/research. The survey also inquired if the newsletter had any impact on their clinical practice. Of 29 residents in the program who received the survey, 27 (93%) responded. The percentage of residents reporting perceived non-zero impact of the newsletter on specific areas of improvement was as follows: interest in scholarly activities/research (44%), knowledge of current psychiatric research (48%), participation in scholarly activities/research (40%), and clinical practice (40%). Exposure index significantly and positively correlated with self-reported percentage attribution for knowledge (correlation coefficient 0.422, p value 0.028) and self-reported impact on clinical practice (correlation coefficient 0.660, p value 0.000), and degree of contribution significantly and positively correlated with self-reported percentage attribution for knowledge (correlation coefficient 0.488, p value 0.010). A resident-led research newsletter can have a positive perceived impact on the residents' interest, knowledge, and participation in research, as well as a positive perceived impact on clinical practice.

Improving clinical instruction: comparison of literature.

PubMed

Giordano, Shelley

2008-01-01

Clinical education in radiologic technology and athletic training is similar in that both programs use clinical sites and clinical instructors to instruct and evaluate student competency. The purpose of this paper is to review and compare the literature from radiologic technology and athletic training clinical education. The literature for this review was obtained using ProQuest and PubMed databases, from the years 1998 to 2006. Research is available for both radiologic technology and athletic training and provides a good comparison. Radiologic technology students experience various clinical stressors that can be remedied by properly trained clinical instructors and instructors who spend quality time with students. The opinions regarding the necessary behaviors of clinical instructors vary between program directors, clinical instructors and students. Cooperation and communication between programs and clinical instructors is important for students to achieve clinical success. A comparison of the literature demonstrates that radiologic technology and athletic training programs are similar; thus, ideas from athletic training can be applied to radiologic technology clinical education.

An Opportunity to Bridge the Gap Between Clinical Research and Clinical Practice: Implications for Clinical Training

PubMed Central

Hershenberg, Rachel; Drabick, Deborah A. G.; Vivian, Dina

2013-01-01

Clinical researchers and clinical practitioners share a goal of increasing the integration of research and clinical practice, which is reflected in an evidence-based practice (EBP) approach to psychology. The EBP framework involves the integration of research findings with clinical expertise and client characteristics, values, and preferences, and consequently provides an important foundation for conducting clinically relevant research, as well as empirically based and clinically sensitive practice. Given the critical role that early training can play in the integration of science and practice and in promoting the future of the field, the present article addresses predoctoral training programs as a context for adopting an EBP approach to clinical work. We address training in the three components of EBP and provide suggestions for curriculum development and practicum training that we hope will contribute to bridging the gap between research and practice. PMID:22642520

The Dental Services Research Scholars Program.

ERIC Educational Resources Information Center

Keenan, Terrance

1983-01-01

A foundation program to bring research on health services and policy issues into the domain of clinical scholarship is described. The principal approach is to train young clinicians for academic careers with major responsibilities in health studies at university health sciences centers. (MSE)

Training the next generation of research mentors: the University of California, San Francisco, Clinical & Translational Science Institute Mentor Development Program.

PubMed

Feldman, Mitchell D; Huang, Laurence; Guglielmo, B Joseph; Jordan, Richard; Kahn, James; Creasman, Jennifer M; Wiener-Kronish, Jeanine P; Lee, Kathryn A; Tehrani, Ariane; Yaffe, Kristine; Brown, Jeanette S

2009-06-01

Mentoring is a critical component of career development and success for clinical translational science research faculty. Yet few programs train faculty in mentoring skills. We describe outcomes from the first two faculty cohorts who completed a Mentor Development Program (MDP) at UCSF. Eligibility includes having dedicated research time, expertise in a scientific area and a desire to be a lead research mentor. A post-MDP survey measured the program's impact on enhancement of five key mentoring skills, change in the Mentors-in-Training (MIT) self-rated importance of being a mentor to their career satisfaction, and overall confidence in their mentoring skills. Since 2007, 29 MITs participated in and 26 completed the MDP. Only 15% of the MITs reported any previous mentor training. Overall, 96% of MITs felt that participation in the MDP helped them to become better mentors. A majority reported a significant increase in confidence in mentoring skills and most reported an increased understanding of important mentoring issues at UCSF. MITs reported increased confidence in overall and specific mentoring skills after completion of the MDP. The MDP can serve as a model for other institutions to develop the next generation of clinical-translational research mentors.

Translational leadership: new approaches to team development.

PubMed

Harrigan, Rosanne C; Emery, Lori M

2010-01-01

Little is known about how to develop collaborative multidisciplinary research teams. Following a comprehensive needs assessment, we developed a curriculum-based, multi-disciplinary, didactic and experiential Translational Leadership training program grounded in adult learning theory. In addition, we constructed collaborative clinical/translational research experiences for trainees to enhance clinical/translational research skills. KEY PROGRAMMATIC ELEMENTS AND PRELIMINARY FINDINGS: This 15-week Translational Leadership program was generated based on the following premises. Academic translational leadership teams should partner and collaborate, customize, make the program relevant to the culture, create a common language, use the best resources, and establish measurable goals for success. Development of effective collaborative research teams is essential to the management of successful translational research teams. Development of these skills in addition to cultural humility will provide the best infrastructure and human capital committed to the resolution of health disparities. Effective translational research teams are more comfortable with the component team members and the communities where they implement their protocols. Our participants highly valued the diverse experiences from this program; several have succeeded in leading community-based research teams. Our Translational Leadership program offers essential skills using adult learning theory for translational researchers who become capable of leading and participating in translational research teams. We believe including community members in the training of translational research programs is an important asset. The multidisciplinary approach develops skills that are also of significant use to the community and its acceptance of responsibility for its own health.

77 FR 49865 - Geriatrics and Gerontology Advisory Committee, Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-17

... Clinical Centers. No time will be allocated at this meeting for receiving oral presentations from the... Veterans and evaluates VA programs designated as Geriatric Research, Education, and Clinical Centers. The meeting will feature presentations and discussions on VA's geriatrics and extended care programs, aging...

WE-G-BRB-00: NIH-Funded Research: Instrumental in the Pursuit of Clinical Trials and Technological Innovations

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

Mentoring interdisciplinary research teams for the study of sex and gender differences in health and disease.

PubMed

Miller, Virginia M; Bahn, Rebecca S

2013-09-01

Initiatives to hasten the translation of basic science discoveries to clinical care have necessitated the development of new approaches to interdisciplinary collaboration and training of future investigators. This has been nowhere more important than in the study of sex differences with implications for extension into areas of gender medicine. Clearly, gaining better understanding of the role that sex and gender play in health and disease is essential to the implementation of truly individualized medicine. This case report will describe our experiences in developing the Mayo Clinic Building Interdisciplinary Research Programs in Women's Health (BIRCWH) program, an interdisciplinary research and training program in women's health and sex and gender differences. We identify both our successes and the barriers we have encountered in order that others who are developing similar programs might benefit from our experiences.

Interdisciplinary Models for Research and Clinical Endeavors in Genomic Medicine: A Scientific Statement From the American Heart Association.

PubMed

Musunuru, Kiran; Arora, Pankaj; Cooke, John P; Ferguson, Jane F; Hershberger, Ray E; Hickey, Kathleen T; Lee, Jin-Moo; Lima, João A C; Loscalzo, Joseph; Pereira, Naveen L; Russell, Mark W; Shah, Svati H; Sheikh, Farah; Wang, Thomas J; MacRae, Calum A

2018-06-01

The completion of the Human Genome Project has unleashed a wealth of human genomics information, but it remains unclear how best to implement this information for the benefit of patients. The standard approach of biomedical research, with researchers pursuing advances in knowledge in the laboratory and, separately, clinicians translating research findings into the clinic as much as decades later, will need to give way to new interdisciplinary models for research in genomic medicine. These models should include scientists and clinicians actively working as teams to study patients and populations recruited in clinical settings and communities to make genomics discoveries-through the combined efforts of data scientists, clinical researchers, epidemiologists, and basic scientists-and to rapidly apply these discoveries in the clinic for the prediction, prevention, diagnosis, prognosis, and treatment of cardiovascular diseases and stroke. The highly publicized US Precision Medicine Initiative, also known as All of Us, is a large-scale program funded by the US National Institutes of Health that will energize these efforts, but several ongoing studies such as the UK Biobank Initiative; the Million Veteran Program; the Electronic Medical Records and Genomics Network; the Kaiser Permanente Research Program on Genes, Environment and Health; and the DiscovEHR collaboration are already providing exemplary models of this kind of interdisciplinary work. In this statement, we outline the opportunities and challenges in broadly implementing new interdisciplinary models in academic medical centers and community settings and bringing the promise of genomics to fruition. © 2018 American Heart Association, Inc.

78 FR 64964 - Office of the Director, National Institutes of Health; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment... on Biomedical and Behavioral Research Facilities. Date: November 12-13, 2013. Time: 8:00 a.m. to 5:00...

Postdoctoral pharmacy industry fellowships: a descriptive analysis of programs and postgraduate positions.

PubMed

Melillo, Stephanie; Gangadharan, Amy; Johnson, Hiliary; Schleck, Patrick; Steinberg, Michael; Alexander, James G

2012-01-01

Postdoctoral pharmacy industry fellowship programs and the employment of fellowship graduates are described. A list of postgraduate industry fellowships was gathered from the 2009 ASHP Midyear Clinical Meeting. Data regarding program characteristics were collected using the Personnel Placement Service database and program-specific brochures. After data compilation, a standardized survey was sent in January 2010 via e-mail to the point of contact for all programs to confirm the accuracy of the program's characteristics. Only academically affiliated industry fellowship programs were analyzed. Retrospective data were collected regarding the first position of employment for all fellows who graduated from the program between 2005 and 2009 and the position of those same individuals at the time of survey completion. Surveys were sent to 64 postgraduate industry fellowship programs affiliated with a school of pharmacy, 56 (87.5%) of whom responded. The departmental breakdown for positions offered (n = 75) across all academically affiliated industry fellowship programs (including nonresponders) was as follows: medical affairs (38.7%, n = 29), clinical research (32.0%, n = 24), regulatory affairs (9.3%, n = 7), commercial (8.0%, n = 6), health economics and outcomes research (8.0%, n = 6), and pharmacovigilance (4.0%, n = 3). Data from fellows during years 1-5 after completion of the industry fellowship indicated that 90.5% of former fellows remained in the industry (n = 238). The postgraduate industry fellowship programs surveyed indicated that the majority of fellowship graduates continued to hold positions in industry after program completion. The majority of industry fellowships and subsequent job placements occurred in the areas of medical affairs, clinical research, and regulatory affairs.

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes

PubMed Central

Stanhope, Steven J.; Wilken, Jason M.; Pruziner, Alison L.; Dearth, Christopher L.; Wyatt, Marilynn; Ziemke, CAPT Gregg W.; Strickland, Rachel; Milbourne, Suzanne A.; Kaufman, Kenton R.

2017-01-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators. BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium’s research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER’s Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium’s vital role, stating the research capabilities of the DoD Advanced Rehabilitation Centers are significantly enhanced and facilitated by the BADER Consortium. PMID:27849456

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium: Reaching in Partnership for Optimal Orthopaedic Rehabilitation Outcomes.

PubMed

Stanhope, Steven J; Wilken, Jason M; Pruziner, Alison L; Dearth, Christopher L; Wyatt, Marilynn; Ziemke, Gregg W; Strickland, Rachel; Milbourne, Suzanne A; Kaufman, Kenton R

2016-11-01

The Bridging Advanced Developments for Exceptional Rehabilitation (BADER) Consortium began in September 2011 as a cooperative agreement with the Department of Defense (DoD) Congressionally Directed Medical Research Programs Peer Reviewed Orthopaedic Research Program. A partnership was formed with DoD Military Treatment Facilities (MTFs), U.S. Department of Veterans Affairs (VA) Centers, the National Institutes of Health (NIH), academia, and industry to rapidly conduct innovative, high-impact, and sustainable clinically relevant research. The BADER Consortium has a unique research capacity-building focus that creates infrastructures and strategically connects and supports research teams to conduct multiteam research initiatives primarily led by MTF and VA investigators.BADER relies on strong partnerships with these agencies to strengthen and support orthopaedic rehabilitation research. Its focus is on the rapid forming and execution of projects focused on obtaining optimal functional outcomes for patients with limb loss and limb injuries. The Consortium is based on an NIH research capacity-building model that comprises essential research support components that are anchored by a set of BADER-funded and initiative-launching studies. Through a partnership with the DoD/VA Extremity Trauma and Amputation Center of Excellence, the BADER Consortium's research initiative-launching program has directly supported the identification and establishment of eight BADER-funded clinical studies. BADER's Clinical Research Core (CRC) staff, who are embedded within each of the MTFs, have supported an additional 37 non-BADER Consortium-funded projects. Additional key research support infrastructures that expedite the process for conducting multisite clinical trials include an omnibus Cooperative Research and Development Agreement and the NIH Clinical Trials Database. A 2015 Defense Health Board report highlighted the Consortium's vital role, stating the research capabilities of the DoD Advanced Rehabilitation Centers are significantly enhanced and facilitated by the BADER Consortium. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Methodology and outcomes of a family medicine research fellowship.

PubMed

Cronholm, Peter F; Straton, Joseph B; Bowman, Marjorie A

2009-08-01

There has not been a strong tradition of training researchers to provide the great amount of new evidence needed for the practice of family medicine. Few models for creating successful family medicine researchers have been presented in the literature. The authors report on the methodology and outcomes of a faculty development research fellowship in the University of Pennsylvania's Department of Family Medicine and Community Health. The fellowship focuses on the two domains-intensive research training and academic career development-and frames them with coursework in a content-appropriate master's degree program and clinical practice in an underserved community. Fifteen fellows have completed the program, which began in 1997. Most fellows' research work has been related to primary care and health disparities. Program completers have been the principal investigators on 39 funded studies and coinvestigators on 24 funded studies. They have, at the time this article was written, described their work in 236 publications, 114 of them peer reviewed. All but one program completer hold academic faculty positions, and 12 practice in underserved areas. In a research-intense institution, the fellowship program successfully trained family physicians to be independent clinical researchers and leaders who have substantially contributed to the national effort to mitigate health disparities through practice and research. The authors suggest that the outcomes strongly support the development of similar training opportunities in family medicine departments in other resource- and research-rich institutions.

Applying Process Improvement Methods to Clinical and Translational Research: Conceptual Framework and Case Examples

PubMed Central

Selker, Harry P.; Leslie, Laurel K.

2015-01-01

Abstract There is growing appreciation that process improvement holds promise for improving quality and efficiency across the translational research continuum but frameworks for such programs are not often described. The purpose of this paper is to present a framework and case examples of a Research Process Improvement Program implemented at Tufts CTSI. To promote research process improvement, we developed online training seminars, workshops, and in‐person consultation models to describe core process improvement principles and methods, demonstrate the use of improvement tools, and illustrate the application of these methods in case examples. We implemented these methods, as well as relational coordination theory, with junior researchers, pilot funding awardees, our CTRC, and CTSI resource and service providers. The program focuses on capacity building to address common process problems and quality gaps that threaten the efficient, timely and successful completion of clinical and translational studies. PMID:26332869

42 CFR 62.8 - What does an individual have to do in return for the scholarship program award?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Service or as a Federal civilian in the full-time clinical practice of the participant's profession and (2... National Research Service Award Program. (1) A Scholarship Program participant who demonstrates exceptional promise for medical research may perform the period of obligated service owed under this section by...

New Visiting Scholars Program at Frederick National Laboratory | Office of Cancer Clinical Proteomics Research

Cancer.gov

The Frederick National Laboratory for Cancer Research is now accepting Expressions of Interest to its new Visiting Scholars Program (VSP). VSP is a unique opportunity for researchers to work on important cancer and AIDS projects with teams of scientists at the only federal national laboratory in the United States devoted exclusively to biomedical research.

[The Clinical Investigation Centers in France: Whatzat? What for? How does it work?].

PubMed

Montagne, O; Le Corvoisier, P

2008-01-01

For the last 15 years, French university-affiliated hospitals have dramatically modified how biomedical research is conducted in France. Multidisciplinary and technically complex research projects are increasingly difficult to conduct in clinical units. To ensure quality, good clinical practice, and security, platforms dedicated to clinical research with specific staff have been implanted. These units, called Clinical Investigation Centers (CICs), are open to academic and industrial investigators working in the medical fields involving patients and healthy volunteers. The CICs' activities are always closely related to the university hospital research programs and can also serve as a tool for locally implanted clinical and fundamental research teams (INSERM). Nowadays, clinical research requires specific tools and platforms. To enhance French university hospital research efficiency and provide a more open research environment, all investigators, on-site as well as from other institutions, are invited to use these cohesive research facilities and skills to conduct protocols that are fully adapted to their needs in optimal conditions of professional clinical research.

Evolution of Clinical Proteomics and its Role in Medicine | Office of Cancer Clinical Proteomics Research

Cancer.gov

NCI's Office of Cancer Clinical Proteomics Research authored a review of the current state of clinical proteomics in the peer-reviewed Journal of Proteome Research. The review highlights outcomes from the CPTC program and also provides a thorough overview of the different technologies that have pushed the field forward. Additionally, the review provides a vision for moving the field forward through linking advances in genomic and proteomic analysis to develop new, molecularly targeted interventions.

The Path to a Cure for Hepatitis C in People With HIV

MedlinePlus

... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

Clinical and translational scientist career success: metrics for evaluation.

PubMed

Lee, Linda S; Pusek, Susan N; McCormack, Wayne T; Helitzer, Deborah L; Martina, Camille A; Dozier, Ann M; Ahluwalia, Jasjit S; Schwartz, Lisa S; McManus, Linda M; Reynolds, Brian D; Haynes, Erin N; Rubio, Doris M

2012-10-01

Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. © 2012 Wiley Periodicals, Inc.

Teen Pregnancy and School-Based Health Clinics. A Family Research Report.

ERIC Educational Resources Information Center

Mosbacker, Barrett

To combat the problem of teenage pregnancy, public health clinics have made birth control counseling and free contraceptives available to minors and many public schools have implemented sex education programs. Despite the development and implementation of these programs, teenage sexual activity and pregnancy have increased. The increase in…

DriveWise: An Interdisciplinary Hospital-Based Driving Assessment Program

ERIC Educational Resources Information Center

O'Connor, Margaret G.; Kapust, Lissa R.; Hollis, Ann M.

2008-01-01

Health care professionals working with the elderly have opportunities through research and clinical practice to shape public policy affecting the older driver. This article describes DriveWise, an interdisciplinary hospital-based driving assessment program developed in response to clinical concerns about the driving safety of individuals with…

Teaching Programs in Geriatric Optometry.

ERIC Educational Resources Information Center

Rosenbloom, Albert A.

1985-01-01

Results of a survey of U.S. and Canadian optometry programs concerning curriculum design, clinical and residency training programs, continuing education, and research projects planned or under way in geriatric optometry are presented and discussed. (MSE)

The University of Indianapolis Woodrow Wilson Indiana Teaching Fellowship Program: Reviewing the Policy Implications of University-Based Urban Clinical Residency Programs in STEM Teacher Preparation

ERIC Educational Resources Information Center

Drake, Jennifer; Moran, Kathryn; Sachs, Deb; Angelov, Azure Dee Smiley; Wheeler, Lynn

2011-01-01

Recent research suggests the need for more intensive clinically-based teacher preparation programs. Many institutions of higher education, in partnership with school districts and education reform organizations, are responding to these findings. This article focuses on the experience of administrators and faculty in one urban teacher residency…

The Pharmacogenomics Research Network Translational Pharmacogenetics Program: Outcomes and Metrics of Pharmacogenetic Implementations Across Diverse Healthcare Systems.

PubMed

Luzum, J A; Pakyz, R E; Elsey, A R; Haidar, C E; Peterson, J F; Whirl-Carrillo, M; Handelman, S K; Palmer, K; Pulley, J M; Beller, M; Schildcrout, J S; Field, J R; Weitzel, K W; Cooper-DeHoff, R M; Cavallari, L H; O'Donnell, P H; Altman, R B; Pereira, N; Ratain, M J; Roden, D M; Embi, P J; Sadee, W; Klein, T E; Johnson, J A; Relling, M V; Wang, L; Weinshilboum, R M; Shuldiner, A R; Freimuth, R R

2017-09-01

Numerous pharmacogenetic clinical guidelines and recommendations have been published, but barriers have hindered the clinical implementation of pharmacogenetics. The Translational Pharmacogenetics Program (TPP) of the National Institutes of Health (NIH) Pharmacogenomics Research Network was established in 2011 to catalog and contribute to the development of pharmacogenetic implementations at eight US healthcare systems, with the goal to disseminate real-world solutions for the barriers to clinical pharmacogenetic implementation. The TPP collected and normalized pharmacogenetic implementation metrics through June 2015, including gene-drug pairs implemented, interpretations of alleles and diplotypes, numbers of tests performed and actionable results, and workflow diagrams. TPP participant institutions developed diverse solutions to overcome many barriers, but the use of Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines provided some consistency among the institutions. The TPP also collected some pharmacogenetic implementation outcomes (scientific, educational, financial, and informatics), which may inform healthcare systems seeking to implement their own pharmacogenetic testing programs. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

42 CFR 68a.11 - How does an individual receive loan repayments beyond the initial two-year contract?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS (CR-LRP) § 68a.11... debt remaining to be repaid and the individual is engaged in approved clinical research as an NIH...

77 FR 25486 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-30

... Scientific Review Special Emphasis Panel; RFA-OD-12-001: Lasker Clinical Research Scholars Program (SI2...; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93...

Mentoring by design: integrating medical professional competencies into bioengineering and medical physics graduate training.

PubMed

Woods, Kendra V; Peek, Kathryn E; Richards-Kortum, Rebecca

2014-12-01

Many students in bioengineering and medical physics doctoral programs plan careers in translational research. However, while such students generally have strong quantitative abilities, they often lack experience with the culture, communication norms, and practice of bedside medicine. This may limit students' ability to function as members of multidisciplinary translational research teams. To improve students' preparation for careers in cancer translational research, we developed and implemented a mentoring program that is integrated with students' doctoral studies and aims to promote competencies in communication, biomedical ethics, teamwork, altruism, multiculturalism, and accountability. Throughout the program, patient-centered approaches and professional competencies are presented as foundational to optimal clinical care and integral to translational research. Mentoring is conducted by senior biomedical faculty and administrators and includes didactic teaching, online learning, laboratory mini-courses, clinical practicums, and multidisciplinary patient planning conferences (year 1); student development and facilitation of problem-based patient cases (year 2); and individualized mentoring based on research problems and progress toward degree completion (years 3-5). Each phase includes formative and summative evaluations. Nineteen students entered the program from 2009 through 2011. On periodic anonymous surveys, the most recent in September 2013, students indicated that the program substantially improved their knowledge of cancer biology, cancer medicine, and academic medicine; that the mentors were knowledgeable, good teachers, and dedicated to students; and that the program motivated them to become well-rounded scientists and scholars. We believe this program can be modified and disseminated to other graduate research and professional health care programs.

Establishment of a research pharmacy to support Ebola clinical research in Liberia.

PubMed

Pierson, Jerome F; Kirchoff, Matthew Carl; Tyee, Rev Tijli; Montello, Michael J; Rhie, Julie K

This article describes the establishment of a research pharmacy to support the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) vaccine study for Ebola virus disease. This article describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia, in 2014 and 2015. The need for the rapid establishment of infrastructure to support the Liberia-United States joint clinical research partnership in response to the emerging Ebola virus disease provided the opportunity for collaboration among Liberian and U.S. pharmacists. Resource austere and research naïve. Research pharmacy prepared and randomized 1500 vaccinations in support of PREVAIL. Experiences of the Liberian and U.S. pharmacists involved in the program are described. The partnership was successful in the conduct of the study. More importantly, the capacity for Liberian pharmacists to support clinical research was established. In addition, the U.S. team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. Published by Elsevier Inc.

Building Innovation and Sustainability in Programs of Research.

PubMed

Villarruel, Antonia M

2018-01-01

Innovation and sustainability are two important concepts of impactful programs of research. While at first glance these concepts and approaches may seem at odds, they are synergistic. We examine the social, political, and policy context as it relates to innovation and sustainability. We present an exemplar of a program of research and discuss factors to consider in developing innovative and sustainable programs of research. Innovation is an important component of sustainable programs of research. Understanding the social and political context and addressing relevant policy issues are factors to be considered in both innovation and sustainability. Innovation and sustainability, important components of research, are also central to clinical practice. Open communication between researchers and clinicians can support the acceleration of innovations and the integration of evidence-based findings in practice. © 2017 Sigma Theta Tau International.

Educating nurses about research ethics and practices with a self-directed practice-based learning program.

PubMed

Cibulka, Nancy J

2011-11-01

Learner-driven and practice-based education programs are recommended for integration of learning. A continuing education program on research ethics was introduced to five nurses in an ambulatory care setting at a Magnet® hospital, using a commercially available web-based course followed by a research practicum. The seasoned nurses reported little previous education in this area. Working with a nurse researcher, three nurses participated in a research project for improving clinic care delivery. The success of the continuing education program was determined by knowledge acquisition, satisfaction with learning activities, and perceived confidence in research participation. This continuing education program was effective in providing for knowledge and skill development in research ethics. The integrative learning format was well received. Copyright 2011, SLACK Incorporated.

National Center for Advancing Translational Sciences

MedlinePlus

... Models Core Technologies Clinical Innovation Clinical and Translational Science Awards Program Rare Diseases Clinical Research Network Patient ... to our monthly e-newsletter. About Translation Translational Science Spectrum Explore the full spectrum of translational science, ...

The Community Mentorship Program: Providing Community-Engagement Opportunities for Early-Stage Clinical and Translational Scientists to Facilitate Research Translation.

PubMed

Patino, Cecilia M; Kubicek, Katrina; Robles, Marisela; Kiger, Holly; Dzekov, Jeanne

2017-02-01

A goal of the Southern California Clinical and Translational Science Institute (SC-CTSI) at the University of Southern California and Children's Hospital Los Angeles is to train early-stage clinical and translational scientists (CTSs) to conduct research that improves the health of diverse communities. This goal aligns well with the Institute of Medicine's recommendations emphasizing community engagement in biomedical research that facilitates research translation. The Community Mentorship Program (CMP), created to complement community-engaged research didactics, matches CTSs with community mentors who help them identify and complete community-engaged experiences that inform their research. The CMP was piloted in 2013-2015 by the SC-CTSI Workforce Development and Community Engagement cores. The CMP team matched three CTSs (assistant professors pursuing mentored career development awards) with mentors at community-based organizations (CBOs) aligned with their research interests. Each mentor-mentee pair signed a memorandum of understanding. The CMP team checked in regularly, monitoring progress and addressing challenges in CTSs' completion of their community-engaged experience. Each pair completed at least one community-engaged activity informing the CTS's research. In exit interviews, the CTSs and CBO mentors expressed satisfaction with the program and stated that they would continue to work together. The CTSs reported that the program provided opportunities to develop networks outside academia, build trust within the community, and receive feedback and learn from individuals in communities affected by their research. The CMP will be expanded to include all eligible early-career CTSs and promoted for use in similar settings outside the SC-CTSI.

Treatment Programs in the National Drug Abuse Treatment Clinical Trials Network

PubMed Central

McCarty, Dennis; Fuller, Bret; Kaskutas, Lee Ann; Wendt, William W.; Nunes, Edward V.; Miller, Michael; Forman, Robert; Magruder, Kathryn M.; Arfken, Cynthia; Copersino, Marc; Floyd, Anthony; Sindelar, Jody; Edmundson, Eldon

2008-01-01

Drug abuse treatment programs and university-based research centers collaborate to test emerging therapies for alcohol and drug disorders in the National Drug Abuse Treatment Clinical Trials Network (CTN). Programs participating in the CTN completed organizational (n = 106 of 112; 95% response rate) and treatment unit surveys (n = 348 of 384; 91% response rate) to describe the levels of care, ancillary services, patient demographics, patient drug use and co-occurring conditions. Analyses describe the corporations participating in the CTN and provide an exploratory assessment of variation in treatment philosophies. A diversity of treatment centers participate in the CTN; not for profit organizations with a primary mission of treating alcohol and drug disorders dominate. Compared to N-SSATS (National Survey of Substance Abuse Treatment Services), programs located in medical settings are over-represented and centers that are mental health clinics are under-represented. Outpatient, methadone, long-term residential and inpatient treatment units differed on patients served and services proved. Larger programs with higher counselor caseloads in residential settings reported more social model characteristics. Programs with higher social model scores were more likely to offer self-help meetings, vocational services and specialized services for women. Conversely, programs with accreditation had less social model influence. The CTN is an ambitious effort to engage community-based treatment organizations into research and more fully integrate research and practice. PMID:17875368

The influence of an elective introductory clinical research course on pharmacy student interest in pursuing research-based careers.

PubMed

Overholser, Brian R; Foster, David R; Henry, Joshua R; Plake, Kimberly S; Sowinski, Kevin M

2010-11-10

To assess the impact of an elective clinical research course on second- and third-year pharmacy students' knowledge of clinical research methods, training programs, career options, and interest in pursuing postgraduate training. A 2-credit hour elective course in clinical research was designed that included lectures, discussions, workshops, and in-class presentations related to study design and implementation, protocol synthesis, research evaluation, ethical and legal considerations, data analysis, and professional opportunities involving clinical research. Learner knowledge of these topics was assessed using several methods, including 3 assignments related to research protocol, ethical documentation, and presentation. A survey instrument designed to evaluate the effect the course had on pharmacy students' knowledge of clinical research methods and interest in pursuing postgraduate training in clinical research was administered. Students who completed the elective had a greater level of familiarity with research-related topics, training options, and career opportunities (p < 0.05) and a greater interest in pursuing a career in clinical research (p < 0.05) than did students in a matched control group. Taking a 2-credit hour elective course in clinical research increased pharmacy students' interest in pursuing a career in clinical research.

78 FR 19711 - Center for Devices and Radiological Health: Experiential Learning Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research... medical device establishments, including, research, manufacturing, academia, and health care facilities.... Clinical use of orthopedic bone void Observation of surgical filler devices. procedures (posterolateral...

History and Outcomes of 50 Years of Physician-Scientist Training in Medical Scientist Training Programs.

PubMed

Harding, Clifford V; Akabas, Myles H; Andersen, Olaf S

2017-10-01

Physician-scientists are needed to continue the great pace of recent biomedical research and translate scientific findings to clinical applications. MD-PhD programs represent one approach to train physician-scientists. MD-PhD training started in the 1950s and expanded greatly with the Medical Scientist Training Program (MSTP), launched in 1964 by the National Institute of General Medical Sciences (NIGMS) at the National Institutes of Health. MD-PhD training has been influenced by substantial changes in medical education, science, and clinical fields since its inception. In 2014, NIGMS held a 50th Anniversary MSTP Symposium highlighting the program and assessing its outcomes. In 2016, there were over 90 active MD-PhD programs in the United States, of which 45 were MSTP supported, with a total of 988 trainee slots. Over 10,000 students have received MSTP support since 1964. The authors present data for the demographic characteristics and outcomes for 9,683 MSTP trainees from 1975-2014. The integration of MD and PhD training has allowed trainees to develop a rigorous foundation in research in concert with clinical training. MSTP graduates have had relative success in obtaining research grants and have become prominent leaders in many biomedical research fields. Many challenges remain, however, including the need to maintain rigorous scientific components in evolving medical curricula, to enhance research-oriented residency and fellowship opportunities in a widening scope of fields targeted by MSTP graduates, to achieve greater racial diversity and gender balance in the physician-scientist workforce, and to sustain subsequent research activities of physician-scientists.

Helping Basic Scientists Engage With Community Partners to Enrich and Accelerate Translational Research.

PubMed

Kost, Rhonda G; Leinberger-Jabari, Andrea; Evering, Teresa H; Holt, Peter R; Neville-Williams, Maija; Vasquez, Kimberly S; Coller, Barry S; Tobin, Jonathan N

2017-03-01

Engaging basic scientists in community-based translational research is challenging but has great potential for improving health. In 2009, The Rockefeller University Center for Clinical and Translational Science partnered with Clinical Directors Network, a practice-based research network (PBRN), to create a community-engaged research navigation (CEnR-Nav) program to foster research pairing basic science and community-driven scientific aims. The program is led by an academic navigator and a PBRN navigator. Through meetings and joint activities, the program facilitates basic science-community partnerships and the development and conduct of joint research protocols. From 2009-2014, 39 investigators pursued 44 preliminary projects through the CEnR-Nav program; 25 of those became 23 approved protocols and 2 substudies. They involved clinical scholar trainees, early-career physician-scientists, faculty, students, postdoctoral fellows, and others. Nineteen (of 25; 76%) identified community partners, of which 9 (47%) named them as coinvestigators. Nine (of 25; 36%) included T3-T4 translational aims. Seven (of 25; 28%) secured external funding, 11 (of 25; 44%) disseminated results through presentations or publications, and 5 (71%) of 7 projects publishing results included a community partner as a coauthor. Of projects with long-term navigator participation, 9 (of 19; 47%) incorporated T3-T4 aims and 7 (of 19; 37%) secured external funding. The CEnR-Nav program provides a model for successfully engaging basic scientists with communities to advance and accelerate translational science. This model's durability and generalizability have not been determined, but it achieves valuable short-term goals and facilitates scientifically meaningful community-academic partnerships.

Society of Pediatric Psychology Diversity Award: Training Underrepresented Minority Students in Psychology

PubMed Central

Mitchell, Monica J.; Crosby, Lori E.

2016-01-01

Improving diversity, particularly among trainees and professionals from underrepresented ethnic minority backgrounds, has been a long-stated goal for the field of Psychology. Research has provided strategies and best practices, such as ensuring cultural sensitivity and relevance in coursework, clinical and research training, promoting a supportive and inclusive climate, providing access to cultural and community opportunities, and increasing insight and cultural competence among professionals (Rogers & Molina, 2006). Despite this, the rates of psychologists from ethnically diverse and underrepresented minority (URM) backgrounds remain low and few published studies have described programmatic efforts to increase diversity within the field. This paper describes the INNOVATIONS training model, which provides community and culturally related research experiences, graduate-school related advising, and mentoring to high school and college students. The paper also examines how the model may support enrollment of URM students in doctoral programs in psychology. Findings indicate that INNOVATIONS supported students’ transition from high school and college to graduate programs (with approximately 75% of students enrolling in Master’s and Doctoral programs). INNOVATIONS also supported students, including those from URM backgrounds, enrolling in doctoral programs (41.7%). Students who were trained in the research assistant track were most likely to enroll in psychology doctoral programs, perhaps as a result of the intensive time and training committed to research and clinical experiences. Data support the importance of research training for URM students pursuing psychology graduate study and the need to ensure cultural relevance of the training. Implications for clinical and pediatric psychology are discussed. PMID:28603680

The evolving role of health care organizations in research.

PubMed

Tuttle, W C; Piland, N F; Smith, H L

1988-01-01

Many hospitals and health care organizations are contending with fierce financial and competitive pressures. Consequently, programs that do not make an immediate contribution to master strategy are often overlooked in the strategic management process. Research programs are a case in point. Basic science, clinical, and health services research programs may help to create a comprehensive and fundamentally sound master strategy. This article discusses the evolving role of health care organizations in research relative to strategy formulation. The primary costs and benefits from participating in research programs are examined. An agenda of questions is presented to help health care organizations determine whether they should incorporate health-related research as a key element in their strategy.

Perspective: Integrating research into surgical residency education: lessons learned from orthopaedic surgery.

PubMed

Atesok, Kivanc I; Hurwitz, Shepard R; Egol, Kenneth A; Ahn, Jaimo; Owens, Brett D; Crosby, Lynn A; Pellegrini, Vincent D

2012-05-01

Orthopaedic research has advanced tremendously in parallel with accelerated progress in medical science. Possession of a fundamental understanding of basic and clinical science has become more essential than previously for orthopaedic surgeons to be able to translate advances in research into clinical practice. The number of medical graduates with prior education in scientific research who choose to pursue careers in orthopaedic surgery is small. Therefore, it is important that a core of research education be included during residency training to ensure the continued advancement of the clinical practice of orthopaedics. The authors examine some of the challenges to a comprehensive research experience during residency, including deficient priority, inadequate institutional infrastructure, financial strain on residency budgets, restricted time, and an insufficient number of mentors to encourage and guide residents to become clinician-scientists. They also present some strategies to overcome these challenges, including development and expansion of residency programs with clinician-scientist pathways, promotion of financial sources, and enhancement of opportunities for residents to interact with mentors who can serve as role models. Successful integration of research education into residency programs will stimulate future orthopaedic surgeons to develop the critical skills to lead musculoskeletal research, comprehend related discoveries, and translate them into patient care. Lessons learned from incorporating research training within orthopaedic residency programs will have broad application across medical specialties-in both primary and subspecialty patient care.

Outcomes of a pharmacotherapy/research rotation in a family medicine training program.

PubMed

Murphy, Julie A; Shrader, Sarah R; Montooth, Audrey K

2008-06-01

The effects of a required pharmacotherapy/research rotation in family medicine residency programs, precepted by a clinical pharmacist, have not been documented in the literature. This study evaluated the effects that a focused pharmacotherapy/research rotation had on family medicine residents' knowledge of pharmacotherapy and research topics. During the first year of a family medicine residency, 15 residents were required to complete 1 month in pharmacotherapy and research. They spent time observing a pharmacist-run clinic and discussing pharmacotherapy and research topics. Residents completed a 20-question pretest and a posttest consisting of 15 pharmacotherapy and five research questions while on the rotation. Higher scores on the tests indicated higher levels of knowledge. The differences in mean scores were evaluated using paired t tests. Overall, the mean score on the pretest was 10.13 compared to 14.67 on the posttest. Mean scores on the pharmacotherapy and research components for the pretests and posttests were 7.27 compared to 10.47 and 2.87 compared to 4.20, respectively. A focused pharmacotherapy/research rotation, precepted by a clinical pharmacist, increases family medicine residents' knowledge.

Development and pilot evaluation of Native CREST-a Cancer Research Experience and Student Training program for Navajo undergraduate students.

PubMed

Hughes, Christine A; Bauer, Mark C; Horazdovsky, Bruce F; Garrison, Edward R; Patten, Christi A; Petersen, Wesley O; Bowman, Clarissa N; Vierkant, Robert A

2013-03-01

The Mayo Clinic Cancer Center and Diné College received funding for a 4-year collaborative P20 planning grant from the National Cancer Institute in 2006. The goal of the partnership was to increase Navajo undergraduates' interest in and commitment to biomedical coursework and careers, especially in cancer research. This paper describes the development, pilot testing, and evaluation of Native CREST (Cancer Research Experience and Student Training), a 10-week cancer research training program providing mentorship in a Mayo Clinic basic science or behavioral cancer research lab for Navajo undergraduate students. Seven Native American undergraduate students (five females, two males) were enrolled during the summers of 2008-2011. Students reported the program influenced their career goals and was valuable to their education and development. These efforts may increase the number of Native American career scientists developing and implementing cancer research, which will ultimately benefit the health of Native American people.

Development and Pilot Evaluation of Native CREST – a Cancer Research Experience and Student Training Program for Navajo Undergraduate Students

PubMed Central

Hughes, Christine A.; Bauer, Mark C.; Horazdovsky, Bruce F.; Garrison, Edward R.; Patten, Christi A.; Petersen, Wesley O.; Bowman, Clarissa N.; Vierkant, Robert A.

2012-01-01

The Mayo Clinic Cancer Center and Diné College received funding for a 4-year collaborative P20 planning grant from the National Cancer Institute in 2006. The goal of the partnership was to increase Navajo undergraduates’ interest in and commitment to biomedical coursework and careers, especially in cancer research. This paper describes the development, pilot testing and evaluation of Native CREST (Cancer Research Experience & Student Training), a 10-week cancer research training program providing mentorship in a Mayo Clinic basic science or behavioral cancer research lab for Navajo undergraduate students. Seven Native American undergraduate students (5 females, 2 males) were enrolled during the summers of 2008 - 2011. Students reported the program influenced their career goals and was valuable to their education and development. These efforts may increase the number of Native American career scientists developing and implementing cancer research, which will ultimately benefit the health of Native American people. PMID:23001889

A community translational research pilot grants program to facilitate community--academic partnerships: lessons from Colorado's clinical translational science awards.

PubMed

Main, Deborah S; Felzien, Maret C; Magid, David J; Calonge, B Ned; O'Brien, Ruth A; Kempe, Allison; Nearing, Kathryn

2012-01-01

National growth in translational research has increased the need for practical tools to improve how academic institutions engage communities in research. One used by the Colorado Clinical and Translational Sciences Institute (CCTSI) to target investments in community-based translational research on health disparities is a Community Engagement (CE) Pilot Grants program. Innovative in design, the program accepts proposals from either community or academic applicants, requires that at least half of requested grant funds go to the community partner, and offers two funding tracks: One to develop new community-academic partnerships (up to $10,000), the other to strengthen existing partnerships through community translational research projects (up to $30,000). We have seen early success in both traditional and capacity building metrics: the initial investment of $272,742 in our first cycle led to over $2.8 million dollars in additional grant funding, with grantees reporting strengthening capacity of their community- academic partnerships and the rigor and relevance of their research.

Quality Control Specialist | Center for Cancer Research

Cancer.gov

Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides analytical experience to work on innovative T-cell therapy for cancer treatment, and responsible for development and execution of analytical assays for generation lot release assays and product CoAs in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Collaborates on the development of templates and processes to enhance the performance of the program Provides organizational and document support including preparation of documents (spreadsheets, web pages, written narrative, meeting minutes) and timely communication with committee and working group members through email contact and websites Establishes, implements and maintains standardized processes and assess performance to make recommendations for improvement Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data Monitors all assigned programs for compliance Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer Attends weekly meetings to discuss upcoming events, tasks, special projects and implementation plans Develops and implements procedures/programs to ensure effective and efficient business and operational processes Identifies potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them Analyzes and tracks initiatives and contracts Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations Aids in measuring, monitoring, problem solving, and reporting of research, operational and business issues Reviews operational requirements for development of or changes to staffing Perform all tasks associated with the manufacture of clinical product (vector or cell) Cross-trains on SOPs and procedures required to support both vector and cell production Follows batch records and SOPs Executes GMP runs in close collaboration with Process Development and Quality Assurance and Quality Control groups Assists in the development of SOPs, batch records, deviations and change controls Troubleshoots processing and equipment issues Participates in investigations regarding out of specifications/trend (OOS/OOT) results; addresses and manages deviations to manufacturing procedures

Clinical and cost outcomes of multifactorial, cardiovascular risk management interventions in worksites: a comprehensive review and analysis.

PubMed

Pelletier, K R

1997-12-01

This paper is a critical review of the clinical and cost outcome evaluation studies of multifactorial, comprehensive, cardiovascular risk management programs in worksites. A comprehensive international literature search conducted under the auspices of the National Heart, Lung and Blood Institute identified 17 articles based on 12 studies that examined the clinical outcomes of multifactorial, comprehensive programs. These articles were identified through MEDLINE, manual searches of recent journals, and through direct inquiries to worksite health promotion researchers. All studies were conducted between 1978 and 1995, with 1978 being the date of the first citation of a methodologically rigorous evaluation. Of the 12 research studies, only 8 utilized the worksite as both the unit of assignment and as the unit of analysis. None of the studies analyzed adequately for cost effectiveness. Given this limitation, this review briefly considers the relevant worksite research that has demonstrated cost outcomes. Worksite-based, multifactorial cardiovascular intervention programs reviewed for this article varied widely in the comprehensiveness, intensity, and duration of both the interventions and evaluations. Results from randomized trials suggest that providing opportunities for individualized, cardiovascular risk reduction counseling for high-risk employees within the context of comprehensive programming may be the critical component of an effective worksite intervention. Despite the many limitations of the current methodologies of the 12 studies, the majority of the research to date indicates the following: (1) favorable clinical and cost outcomes; (2) that more recent and more rigorously designed research tends to support rather than refute earlier and less rigorously designed studies; and (3) that rather than interpreting the methodological flaws and diversity as inherently negative, one may consider it as indicative of a robust phenomena evident in many types of worksites, with diverse employees, differing interventions, and varying degrees of methodological sophistication. Results of these studies reviewed provide both cautious optimism about the effectiveness of these worksite programs and insights regarding the essential components and characteristics of successful programs.

The Mentor Apprentice Program--A Modest Proposal for Alleviating the Scarcity of Clinical Researchers in Dentistry.

ERIC Educational Resources Information Center

Neidle, Enid A.

1985-01-01

The acute deficiency in the number of clinical dental faculty who are trained to do high-quality research is discussed. There is a paucity of role models for research in dental schools. Students at dental schools have no opportunity to gain first hand knowledge of how dentist-scientists function. (MLW)

An International Basic Science and Clinical Research Summer Program for Medical Students

ERIC Educational Resources Information Center

Ramjiawan, Bram; Pierce, Grant N.; Anindo, Mohammad Iffat Kabir; AlKukhun, Abedalrazaq; Alshammari, Abdullah; Chamsi, Ahmad Talal; Abousaleh, Mohannad; Alkhani, Anas; Ganguly, Pallab K.

2012-01-01

An important part of training the next generation of physicians is ensuring that they are exposed to the integral role that research plays in improving medical treatment. However, medical students often do not have sufficient time to be trained to carry out any projects in biomedical and clinical research. Many medical students also fail to…

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team.

PubMed

Green, Beverly B; Fuller, Sharon; Anderson, Melissa L; Mahoney, Christine; Mendy, Peter; Powell, Susan L

2017-01-01

Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic's overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it.

Participatory action research: involving students in parent education.

PubMed

Fowler, Cathrine; Wu, Cynthia; Lam, Winsome

2014-01-01

Competition for scarce clinical placements has increased requiring new and innovative models to be developed to meet the growing need. A participatory action research project was used to provide a community nursing clinical experience of involvement in parent education. Nine Hong Kong nursing students self-selected to participate in the project to implement a parenting program called Parenting Young Children in a Digital World. Three project cycles were used: needs identification, skills development and program implementation. Students were fully involved in each cycle's planning, action and reflection phase. Qualitative and quantitative data were collected to inform the project. The overall outcome of the project was the provision of a rich and viable clinical placement experience that created significant learning opportunities for the students and researchers. This paper will explore the student's participation in this PAR project as an innovative clinical practice opportunity. Copyright © 2013 Elsevier Ltd. All rights reserved.

Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

PubMed

Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

2016-07-01

A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information. © The Author(s) 2015.

NCI National Clinical Trials Network Structure

Cancer.gov

Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Clinical Research and Clinical Trials

MedlinePlus

... NICHD News Videos OUTREACH Safe to Sleep® National Child & Maternal Health Education Program RELATED WEBSITES NIH.gov HHS.gov USA.gov ClinicalTrials.gov WEBSITE POLICIES Disclaimer FOIA Privacy Policy Accessibility NIH...Turning Discovery Into Health ®

Clinical Preceptors' Perspectives on Clinical Education in Post-Professional Athletic Training Education Programs

ERIC Educational Resources Information Center

Phan, Kelvin; McCarty, Cailee W.; Mutchler, Jessica M.; Van Lunen, Bonnie

2012-01-01

Context: Clinical education is the interaction between a clinical preceptor and student within the clinical setting to help the student progress as a clinician. Post-professional athletic training clinical education is especially important to improve these students' clinical knowledge and skills. However, little research has been conducted to…

A Community-Engaged Cardiovascular Health Disparities Research Training Curriculum: Implementation and Preliminary Outcomes

PubMed Central

Golden, Sherita Hill; Purnell, Tanjala; Halbert, Jennifer P.; Matens, Richard; Miller, Edgar R. “Pete”; Levine, David M.; Nguyen, Tam H.; Gudzune, Kimberly A.; Crews, Deidra C.; Mahlangu-Ngcobo, Mankekolo; Cooper, Lisa A.

2014-01-01

To overcome cardiovascular disease (CVD) disparities impacting high-risk populations, it is critical to train researchers and leaders in conducting community-engaged CVD disparities research. The authors summarize the key elements, implementation, and preliminary outcomes of the CVD Disparities Fellowship and Summer Internship Programs at the Johns Hopkins University Schools of Medicine, Nursing, and Bloomberg School of Public Health. In 2010, program faculty and coordinators established a trans-disciplinary CVD disparities training and career development fellowship program for scientific investigators who desire to conduct community-engaged clinical and translational disparities research. The program was developed to enhance mentorship support and research training for faculty, post-doctoral fellows, and pre-doctoral students interested in conducting CVD disparities research. A CVD Disparities Summer Internship Program for undergraduate and pre-professional students was also created to provide a broad experience in public health and health disparities in Baltimore, Maryland, with a focus on CVD. Since 2010, 39 pre-doctoral, post-doctoral, and faculty fellows have completed the program. Participating fellows have published disparities-related research and given presentations both nationally and internationally. Five research grant awards have been received by faculty fellows. Eight undergraduates, 1 post-baccalaureate, and 2 medical professional students representing seven universities have participated in the summer undergraduate internship. Over half of the undergraduate students are applying to or have been accepted into medical or graduate school. The tailored CVD health disparities training curriculum has been successful at equipping varying levels of trainees (from undergraduate students to faculty) with clinical research and public health expertise to conducting community-engaged CVD disparities research. PMID:25054421

New clinical program will study metastatic colorectal cancer in viable patient tissue samples | Center for Cancer Research

Cancer.gov

Jonathan Hernandez, M.D., Investigator in the Thoracic and Gastrointestinal Oncology Branch, has established a new clinical program to understand how metastases form, which may yield insights into how to treat or even prevent them. The program will conduct first-of-their-kind studies with tumor-containing liver that is kept alive outside of the body after it is removed from a

Basic science faculty in surgical departments: advantages, disadvantages and opportunities.

PubMed

Chinoy, Mala R; Moskowitz, Jay; Wilmore, Douglas W; Souba, Wiley W

2005-01-01

The number of Ph.D. faculty in clinical departments now exceeds the number of Ph.D. faculty in basic science departments. Given the escalating pressures on academic surgeons to produce in the clinical arena, the recruitment and retention of high-quality Ph.D.s will become critical to the success of an academic surgical department. This success will be as dependent on the surgical faculty understanding the importance of the partnership as the success of the Ph.D. investigator. Tighter alignment among the various clinical and research programs and between surgeons and basic scientists will facilitate the generation of new knowledge that can be translated into useful products and services (thus improving care). To capitalize on what Ph.D.s bring to the table, surgery departments may need to establish a more formal research infrastructure that encourages the ongoing exchange of ideas and resources. Physically removing barriers between the research groups, encouraging the open exchange of techniques and observations and sharing core laboratories is characteristic of successful research teams. These strategies can meaningfully contribute to developing successful training program grants, program projects and bringing greater research recognition to the department of surgery.

Linking academic and clinical missions: UC Davis' integrated AHC.

PubMed

Pomeroy, Claire; Rice, Ann; McGowan, William; Osburn, Nathan

2008-09-01

Academic health centers (AHCs) rely on cross-subsidization of education and research programs by the clinical enterprise, but this is becoming more challenging as clinical reimbursements decline. These new realities provide an important opportunity to reevaluate the relationships between medical schools and academic medical centers. The authors examine the benefits of their ongoing commitment to create a fully integrated AHC at the University of California (UC) Davis, discussing strategies that serve as catalysts for continued growth. They explore how investments of proceeds from the clinical enterprise directly enhance educational and research initiatives, which, in turn, increase the success of patient-care programs. This has created a cycle of excellence that leads to an enhanced reputation for the entire health system. One strategy involves using clinical margins to "prime the pump" in anticipation of major research initiatives, resulting in rapid increases in external research funding and academic recognition. In turn, this facilitates recruitment of high-quality faculty and staff, improving the ability to deliver expert clinical care. The overall enhanced institutional reputation positions both the clinical and academic programs for further success. The authors posit that such approaches require executive-level commitment to a single strategic vision, unified leadership, and collaborative financial and operational decision making. Adopting such changes is not without challenges, which are discussed, but the authors suggest that an integrated AHC fosters optimized operations, enhanced reputation, and stronger performance across all mission areas. They also provide examples of how the UC Davis Health System has thus attracted philanthropists and investments from the private sector.

Of Course: Prerequisite Courses for Admission into APA-Accredited Clinical and Counseling Psychology Programs

ERIC Educational Resources Information Center

Norcross, John C.; Sayette, Michael A.; Stratigis, Katerina Y.; Zimmerman, Barrett E.

2014-01-01

Students often inquire about which psychology courses to complete in preparation for graduate school. This study provides data that enable students and their advisors to make research-informed decisions. We surveyed the directors of the 304 American Psychological Association-accredited doctoral programs in clinical and counseling psychology (97%…

Preparing PhD-Level Clinical Social Work Practitioners for the 21st Century

ERIC Educational Resources Information Center

Berzoff, Joan; Drisko, James

2015-01-01

Social work doctoral programs are not adequately preparing students to educate future clinical practitioners. Social work is predominantly a practice profession. Social work's PhD programs must continue the education of excellent researchers while also educating for excellence in practice, teaching, field liaison, and the supervision of practice.…

Exploring international clinical education in US-based programs: identifying common practices and modifying an existing conceptual model of international service-learning.

PubMed

Pechak, Celia M; Black, Jill D

2014-02-01

Increasingly physical therapist students complete part of their clinical training outside of their home country. This trend is understudied. The purposes of this study were to: (1) explore, in depth, various international clinical education (ICE) programs; and (2) determine whether the Conceptual Model of Optimal International Service-Learning (ISL) could be applied or adapted to represent ICE. Qualitative content analysis was used to analyze ICE programs and consider modification of an existing ISL conceptual model for ICE. Fifteen faculty in the United States currently involved in ICE were interviewed. The interview transcriptions were systematically analyzed by two researchers. Three models of ICE practices emerged: (1) a traditional clinical education model where local clinical instructors (CIs) focus on the development of clinical skills; (2) a global health model where US-based CIs provide the supervision in the international setting, and learning outcomes emphasized global health and cultural competency; and (3) an ICE/ISL hybrid where US-based CIs supervise the students, and the foci includes community service. Additionally the data supported revising the ISL model's essential core conditions, components and consequence for ICE. The ICE conceptual model may provide a useful framework for future ICE program development and research.

Multidisciplinary acute care research organization (MACRO): if you build it, they will come.

PubMed

Early, Barbara J; Huang, David T; Callaway, Clifton W; Zenati, Mazen; Angus, Derek C; Gunn, Scott R; Yealy, Donald M; Unikel, Daniel; Billiar, Timothy R; Peitzman, Andrew B; Sperry, Jason L

2013-07-01

Clinical research will increasingly play a core role in the evolution and growth of acute care surgery program development across the country. What constitutes an efficient and effective clinical research infrastructure in the current fiscal and academic environment remains obscure. We sought to characterize the effects of implementation of a multidisciplinary acute care research organization (MACRO) at a busy tertiary referral university setting. In 2008, to minimize redundancy and cost as well as to maximize existing resources promoting acute care research, MACRO was created, unifying clinical research infrastructure among the Departments of Critical Care Medicine, Emergency Medicine, and Surgery. During the periods 2008 to 2012, we performed a retrospective analysis and determined volume of clinical studies, patient enrollment for both observational and interventional trials, and staff growth since MACRO's origination and characterized changes over time. From 2008 to 2011, the volume of patients enrolled in clinical studies, which MACRO facilitates has significantly increased more than 300%. The percentage of interventional/observational trials has remained stable during the same period (50-60%). Staff has increased from 6 coordinators to 10, with an additional 15 research associates allowing 24/7 service. With this significant growth, MACRO has become financially self-sufficient, and additional outside departments now seek MACRO's services. Appropriate organization of acute care clinical research infrastructure minimizes redundancy and can promote sustainable, efficient growth in the current academic environment. Further studies are required to determine if similar models can be successful at other acute care surgery programs.

Fluoridation Basics

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Dental Fluorosis

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Clinician–Investigator Training and the Need to Pilot New Approaches to Recruiting and Retaining This Workforce

PubMed Central

Hall, Alison K.; Lund, P. Kay

2017-01-01

Clinician–investigators, also called physician–scientists, offer critical knowledge and perspectives that benefit research on basic science mechanisms, improved diagnostic and therapeutic approaches, population and outcomes medicine, health policy, and health services, yet few clinically trained health professionals pursue a research career. Sustaining this workforce requires attention to the unique challenges faced by investigators who must achieve clinical and research competence during training and their careers. These challenges include the duration of required clinical training, limited or discontinuous research opportunities, high levels of educational debt, balancing the dual obligations and rewards of clinical care and research, competition for research funding, and the need for leadership development after training. Women and individuals from underrepresented racial and ethnic groups comprise a small percentage of this workforce. The authors summarize the recent literature on training for clinician–investigators, emphasizing approaches with encouraging outcomes that warrant broader implementation. Using this overview as background, they convened three workshops at the National Institutes of Health in 2016 to identify and refine key priorities for potential new pilot programs to recruit and retain the clinician–investigator workforce. From these workshops emerged three priorities for future pilot programs: (1) support for research in residency, (2) new research on-ramps for health professionals at multiple career stages, and (3) national networks to diversify and sustain clinician–investigator faculty. Implementation of any pilot program will require coordinated commitment from academic health centers, medical licensing/certification boards, professional societies, and clinician–investigators themselves, in addition to support from the National Institutes of Health. PMID:28767499

Clinician-Investigator Training and the Need to Pilot New Approaches to Recruiting and Retaining This Workforce.

PubMed

Hall, Alison K; Mills, Sherry L; Lund, P Kay

2017-10-01

Clinician-investigators, also called physician-scientists, offer critical knowledge and perspectives that benefit research on basic science mechanisms, improved diagnostic and therapeutic approaches, population and outcomes medicine, health policy, and health services, yet few clinically trained health professionals pursue a research career. Sustaining this workforce requires attention to the unique challenges faced by investigators who must achieve clinical and research competence during training and their careers. These challenges include the duration of required clinical training, limited or discontinuous research opportunities, high levels of educational debt, balancing the dual obligations and rewards of clinical care and research, competition for research funding, and the need for leadership development after training. Women and individuals from underrepresented racial and ethnic groups comprise a small percentage of this workforce.The authors summarize the recent literature on training for clinician-investigators, emphasizing approaches with encouraging outcomes that warrant broader implementation. Using this overview as background, they convened three workshops at the National Institutes of Health in 2016 to identify and refine key priorities for potential new pilot programs to recruit and retain the clinician-investigator workforce. From these workshops emerged three priorities for future pilot programs: (1) support for research in residency, (2) new research on-ramps for health professionals at multiple career stages, and (3) national networks to diversify and sustain clinician-investigator faculty. Implementation of any pilot program will require coordinated commitment from academic health centers, medical licensing/certification boards, professional societies, and clinician-investigators themselves, in addition to support from the National Institutes of Health.

Analysis of professional competencies for the clinical research data management profession: implications for training and professional certification.

PubMed

Zozus, Meredith N; Lazarov, Angel; Smith, Leigh R; Breen, Tim E; Krikorian, Susan L; Zbyszewski, Patrick S; Knoll, Shelly K; Jendrasek, Debra A; Perrin, Derek C; Zambas, Demetris N; Williams, Tremaine B; Pieper, Carl F

2017-07-01

To assess and refine competencies for the clinical research data management profession. Based on prior work developing and maintaining a practice standard and professional certification exam, a survey was administered to a captive group of clinical research data managers to assess professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. Respondents confirmed a set of 91 professional competencies. As expected, differences were seen in job tasks between early- to mid-career and mid- to late-career practitioners. Respondents indicated growing variability in types of studies for which they managed data and types of data managed. Respondents adapted favorably to the separate articulation of professional competencies vs foundational knowledge. The increases in the types of data managed and variety of research settings in which data are managed indicate a need for formal education in principles and methods that can be applied to different research contexts (ie, formal degree programs supporting the profession), and stronger links with the informatics scientific discipline, clinical research informatics in particular. The results document the scope of the profession and will serve as a foundation for the next revision of the Certified Clinical Data Manager TM exam. A clear articulation of professional competencies and necessary foundational knowledge could inform the content of graduate degree programs or tracks in areas such as clinical research informatics that will develop the current and future clinical research data management workforce. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

SHAPING A NEW GENERATION OF HISPANIC CLINICAL AND TRANSLATIONAL RESEARCHERS ADDRESSING MINORITY HEALTH AND HEALTH DISPARITIES

PubMed Central

Estape, Estela S.; Segarra, Barbara; Baez, Adriana; Huertas, Aracelis; Diaz, Clemente; Frontera, Walter

2012-01-01

In 2011, research educators face significant challenges. Training programs in Clinical and Translational Research need to develop or enhance their curriculum to comply with new scientific trends and government policies. Curricula must impart the skills and competencies needed to help facilitate the dissemination and transfer of scientific advances at a faster pace than current health policy and practice. Clinical and translational researchers are facing also the need of new paradigms for effective collaboration, and resource sharing while using the best educational models. Both government and public policy makers emphasize addressing the goals of improving health quality and elimination of health disparities. To help achieve this goal, our academic institution is taking an active role and striving to develop an environment that fosters the career development of clinical and translational researchers. Consonant with this vision, in 2002 the University of Puerto Rico, Medical Sciences Campus School of Health Professions and School of Medicine initiated a multidisciplinary post-doctoral Master of Science in Clinical Research focused in training Hispanics who will address minority health and health disparities research. Recently, we proposed a curriculum revision to enhance this commitment in promoting competency-based curricula for clinician-scientists in clinical and translational sciences. The revised program will be a post-doctoral Master of Science in Clinical and Translational Research (MCTR), expanding its outreach by actively engaging in establishing new collaborations and partnerships that will increase our capability to diversify our educational efforts and make significant contributions to help reduce and eliminate the gap in health disparities. PMID:22263296

Synergies and Distinctions between Computational Disciplines in Biomedical Research: Perspective from the Clinical and Translational Science Award Programs

PubMed Central

Bernstam, Elmer V.; Hersh, William R.; Johnson, Stephen B.; Chute, Christopher G.; Nguyen, Hien; Sim, Ida; Nahm, Meredith; Weiner, Mark; Miller, Perry; DiLaura, Robert P.; Overcash, Marc; Lehmann, Harold P.; Eichmann, David; Athey, Brian D.; Scheuermann, Richard H.; Anderson, Nick; Starren, Justin B.; Harris, Paul A.; Smith, Jack W.; Barbour, Ed; Silverstein, Jonathan C.; Krusch, David A.; Nagarajan, Rakesh; Becich, Michael J.

2010-01-01

Clinical and translational research increasingly requires computation. Projects may involve multiple computationally-oriented groups including information technology (IT) professionals, computer scientists and biomedical informaticians. However, many biomedical researchers are not aware of the distinctions among these complementary groups, leading to confusion, delays and sub-optimal results. Although written from the perspective of clinical and translational science award (CTSA) programs within academic medical centers, the paper addresses issues that extend beyond clinical and translational research. The authors describe the complementary but distinct roles of operational IT, research IT, computer science and biomedical informatics using a clinical data warehouse as a running example. In general, IT professionals focus on technology. The authors distinguish between two types of IT groups within academic medical centers: central or administrative IT (supporting the administrative computing needs of large organizations) and research IT (supporting the computing needs of researchers). Computer scientists focus on general issues of computation such as designing faster computers or more efficient algorithms, rather than specific applications. In contrast, informaticians are concerned with data, information and knowledge. Biomedical informaticians draw on a variety of tools, including but not limited to computers, to solve information problems in health care and biomedicine. The paper concludes with recommendations regarding administrative structures that can help to maximize the benefit of computation to biomedical research within academic health centers. PMID:19550198

Implementation Research Workshop in Argentina: Moving Research into Practice

Cancer.gov

Research on implementation science addresses the level to which health interventions can fit within real-world public health and clinical service systems. The overall goal of the Introduction to Cancer Program Planning and Implementation Research Workshop was to train a critical mass of researchers, program managers, practitioners, and policy makers that can apply the knowledge gained on implementation and dissemination research to promote evidence-based interventions to reduce the cancer burden in the country and globally.

Dissemination research: the University of Wisconsin Population Health Institute.

PubMed

Remington, Patrick L; Moberg, D Paul; Booske, Bridget C; Ceraso, Marion; Friedsam, Donna; Kindig, David A

2009-08-01

Despite significant accomplishments in basic, clinical, and population health research, a wide gap persists between research discoveries (ie, what we know) and actual practice (ie, what we do). The University of Wisconsin Population Health Institute (Institute) researchers study the process and outcomes of disseminating evidence-based public health programs and policies into practice. This paper briefly describes the approach and experience of the Institute's programs in population health assessment, health policy, program evaluation, and education and training. An essential component of this dissemination research program is the active engagement of the practitioners and policymakers. Each of the Institute's programs conducts data collection, analysis, education, and dialogue with practitioners that is closely tied to the planning, implementation, and evaluation of programs and policies. Our approach involves a reciprocal exchange of knowledge with non-academic partners, such that research informs practice and practice informs research. Dissemination research serves an important role along the continuum of research and is increasingly recognized as an important way to improve population health by accelerating the translation of research into practice.

Adapting a Program to Inform African American and Hispanic American Women About Cancer Clinical Trials

PubMed Central

Gonzalez, Jenny; Mumman, Manpreet; Cullen, Lisa; LaHousse, Sheila F.; Malcarne, Vanessa; Conde, Viridiana; Riley, Natasha

2010-01-01

The dearth of evidence-based clinical trial education programs may contribute to the underrepresentation of African American and Hispanic American women in cancer research studies. This study used focus group-derived data from 80 women distributed among eight Spanish- and English-language focus groups. These data guided the researchers’ adaptation and refinement of the National Cancer Institute’s various clinical trials education programs into a program that was specifically focused on meeting the information needs of minority women and addressing the barriers to study participation that they perceived. A “sisterhood” theme was adopted and woven throughout the presentation. PMID:20146043

Clinical and Translational Scientist Career Success: Metrics for Evaluation

PubMed Central

Lee, Linda S.; Pusek, Susan N.; McCormack, Wayne T.; Helitzer, Deborah L.; Martina, Camille A.; Dozier, Ann M.; Ahluwalia, Jasjit S.; Schwartz, Lisa S.; McManus, Linda M.; Reynolds, Brian D.; Haynes, Erin N.; Rubio, Doris M.

2012-01-01

Abstract Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. Clin Trans Sci 2012; Volume 5: 400–407 PMID:23067352

Use of a Relational Database to Support Clinical Research: Application in a Diabetes Program

PubMed Central

Lomatch, Diane; Truax, Terry; Savage, Peter

1981-01-01

A database has been established to support conduct of clinical research and monitor delivery of medical care for 1200 diabetic patients as part of the Michigan Diabetes Research and Training Center (MDRTC). Use of an intelligent microcomputer to enter and retrieve the data and use of a relational database management system (DBMS) to store and manage data have provided a flexible, efficient method of achieving both support of small projects and monitoring overall activity of the Diabetes Center Unit (DCU). Simplicity of access to data, efficiency in providing data for unanticipated requests, ease of manipulations of relations, security and “logical data independence” were important factors in choosing a relational DBMS. The ability to interface with an interactive statistical program and a graphics program is a major advantage of this system. Out database currently provides support for the operation and analysis of several ongoing research projects.

NCTN Budget

Cancer.gov

Learn about the budget for the National Clinical Trials Network (NCTN), a National Cancer Institute program that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

Relationship Between the Number of Clinical Sites in Radiography Programs and Job Placement Rates of Graduates.

PubMed

Harrell, Angela; Matthews, Eric

2016-07-01

To determine whether a relationship exists between the number of clinical sites available in radiography programs accredited by the Joint Review Committee on Education in Radiologic Technology and the job placement rates of graduates. We performed a secondary analysis of data on job placement rates and the number of clinical sites available in 438 degree-granting radiography programs from January 2015 to March 2015. A weak, negative, nonsignificant correlation existed between the number of clinical sites and the job placement rate (Spearman's rho = -.113, n = 438, P = .018). The coefficient of determination was 1.28%.Discussion Research evaluating factors contributing to graduate employability is limited but indicates no need for radiography program administrators to adjust clinical site numbers solely on the basis of improving graduate employability. The number of clinical sites available in a radiography program is not related to the job placement rate of its graduates. ©2016 American Society of Radiologic Technologists.

Increasing Nursing Faculty Research: The Iowa Gerontological Nursing Research and Regional Research Consortium Strategies

PubMed Central

Maas, Meridean L.; Conn, Vicki; Buckwalter, Kathleen C.; Herr, Keela; Tripp-Reimer, Toni

2012-01-01

Purpose Research development and regional consortium strategies are described to assist schools in all countries extend their gerontological nursing research productivity. The strategies, collaboration and mentoring experiences, and outcomes are also shared to illustrate a highly successful approach in increasing faculty programs of nursing research in a focused area of inquiry. Design A case description of gerontological nursing research development and regional consortium strategies in schools of nursing is used. The regional consortium included 17 schools of nursing that are working to increase faculty programs of gerontological nursing research. Survey responses describing publications, presentations, and research funding awards from 65 of 114 total faculty participants in consortium opportunities (pilot and mentoring grant participants, participants in summer scholars’ grantsmanship seminars) were collected annually from 1995 through 2008 to describe outcomes. Findings From 1994 through 2008, faculty participants from the consortium schools who responded to the annual surveys reported a total of 597 gerontological nursing publications, 527 presentations at research conferences, funding of 221 small and internal grants, and 130 external grant awards, including 47R-series grants and 4 K awards. Conclusions There is an urgent need for more nurse faculty with programs of research to inform the health care of persons and support the preparation of nurse clinicians and faculty. The shortage of nurse scientists with active programs of gerontological research is especially serious and limits the number of faculty who are needed to prepare future gerontological nurses, particularly those with doctoral degrees who will assume faculty positions. Further, junior faculty with a gerontological nursing research foci often lack the colleagues, mentors, and environments needed to develop successful research careers. The outcomes of the development and regional consortium strategies suggest that the principles of extending collaboration, mentoring, and resource sharing are useful to augment faculty research opportunities, networking and support, and to increase productivity in individual schools. Clinical Relevance Clinical relevance includes: (a) implications for preparing nurse scientists and academicians who are and will be needed to train nurses for clinical practice, and (b) development of more faculty programs of research to provide systematic evidence to inform nursing practice. PMID:19941587

Other Fluoride Products

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Facts and Statistics

MedlinePlus

... Drug Listings Blood Cancer Conferences Researchers & Healthcare Professionals Academic Grants Academic Grant Programs Apply for a Grant Grant Finder Therapy Acceleration Program Academic Concierge Biotechnology Accelerator Clinical Trials Division Resources for ...

New ideas in asthma and allergy research: creating a multidisciplinary graduate school

PubMed Central

Björkstén, Bengt; Graninger, Göran; Ekman, Gunilla Jacobsson

2003-01-01

The spring term of 2001 saw the start of a new, unique graduate research training program at the Centre for Allergy Research at the Karolinska Institutet in Stockholm, Sweden. The program was created to bridge the gaps between basic, clinical, social, and behavioral sciences and to establish a global approach to the study of asthma and allergy. A reflection, two years on, discusses the strategies that are key to this model’s success and the challenges in introducing a multidisciplinary research program. PMID:12975463

[Integration of clinical and biological data in clinical practice using bioinformatics].

PubMed

Coltell, Oscar; Arregui, María; Fabregat, Antonio; Portolés, Olga

2008-05-01

The aim of our work is to describe essential aspects of Medical Informatics, Bioinformatics and Biomedical Informatics, that are used in biomedical research and clinical practice. These disciplines have emerged from the need to find new scientific and technical approaches to manage, store, analyze and report data generated in clinical practice and molecular biology and other medical specialties. It can be also useful to integrate research information generated in different areas of health care. Moreover, these disciplines are interdisciplinary and integrative, two key features not shared by other areas of medical knowledge. Finally, when Bioinformatics and Biomedical Informatics approach to medical investigation and practice are applied, a new discipline, called Clinical Bioinformatics, emerges. The latter requires a specific training program to create a new professional profile. We have not been able to find a specific training program in Clinical Bioinformatics in Spain.

Models of interinstitutional partnerships between research intensive universities and minority serving institutions (MSI) across the Clinical Translational Science Award (CTSA) consortium.

PubMed

Ofili, Elizabeth O; Fair, Alecia; Norris, Keith; Verbalis, Joseph G; Poland, Russell; Bernard, Gordon; Stephens, David S; Dubinett, Steven M; Imperato-McGinley, Julianne; Dottin, Robert P; Pulley, Jill; West, Andrew; Brown, Arleen; Mellman, Thomas A

2013-12-01

Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium-level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities. © 2013 Wiley Periodicals, Inc.

Models of Interinstitutional Partnerships between Research Intensive Universities and Minority Serving Institutions (MSI) across the Clinical Translational Science Award (CTSA) Consortium

PubMed Central

Fair, Alecia; Norris, Keith; Verbalis, Joseph G.; Poland, Russell; Bernard, Gordon; Stephens, David S.; Dubinett, Steven M.; Imperato‐McGinley, Julianne; Dottin, Robert P.; Pulley, Jill; West, Andrew; Brown, Arleen; Mellman, Thomas A.

2013-01-01

Abstract Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium‐level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities. PMID:24119157

Research Challenges and Opportunities for Clinically Oriented Academic Radiology Departments.

PubMed

Decker, Summer J; Grajo, Joseph R; Hazelton, Todd R; Hoang, Kimberly N; McDonald, Jennifer S; Otero, Hansel J; Patel, Midhir J; Prober, Allen S; Retrouvey, Michele; Rosenkrantz, Andrew B; Roth, Christopher G; Ward, Robert J

2016-01-01

Between 2004 and 2012, US funding for the biomedical sciences decreased to historic lows. Health-related research was crippled by receiving only 1/20th of overall federal scientific funding. Despite the current funding climate, there is increased pressure on academic radiology programs to establish productive research programs. Whereas larger programs have resources that can be utilized at their institutions, small to medium-sized programs often struggle with lack of infrastructure and support. To address these concerns, the Association of University Radiologists' Radiology Research Alliance developed a task force to explore any untapped research productivity potential in these smaller radiology departments. We conducted an online survey of faculty at smaller clinically funded programs and found that while they were interested in doing research and felt it was important to the success of the field, barriers such as lack of resources and time were proving difficult to overcome. One potential solution proposed by this task force is a collaborative structured research model in which multiple participants from multiple institutions come together in well-defined roles that allow for an equitable distribution of research tasks and pooling of resources and expertise. Under this model, smaller programs will have an opportunity to share their unique perspective on how to address research topics and make a measureable impact on the field of radiology as a whole. Through a health services focus, projects are more likely to succeed in the context of limited funding and infrastructure while simultaneously providing value to the field. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Key factors of clinical research network capacity building.

PubMed

Li, Guowei; Wu, Qianyu; Jin, Yanling; Vanniyasingam, Thuva; Thabane, Lehana

2018-01-01

In general, clinical research network capacity building refers to programs aimed at enhancing networks of researchers to conduct clinical research. Although in the literature there is a large body of research on how to develop and build capacity in clinical research networks, the conceptualizations and implementations remain controversial and challenging. Moreover, the experiences learnt from the past accomplishments and failures can assist in the future capacity building efforts to be more practical, effective and efficient. In this paper, we aim to provide an overview of capacity building in clinical research network by (1) identifying the key barriers to clinical research network capacity building, (2) providing insights into how to overcome those obstacles, and (3) sharing our experiences in collaborating with national and international partners to build capacity in clinical research networks. In conclusion, we have provided some insight into how to address the key factors of clinical research network capacity building and shared some empirical experiences. A successful capacity building practice requires a joint endeavor to procure sufficient resources and support from the relevant stakeholders, to ensure its efficiency, cost-effectiveness, and sustainability.

75 FR 28262 - Office of the Director, National Institutes of Health; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... discussion are: (1) NIH Director's Report; (2) Work Group for Human Embryonic Stem Cell Review; (3) Work... available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93...

Client Narratives about Experiences with a Multicouple Treatment Program for Intimate Partner Violence

ERIC Educational Resources Information Center

Todahl, Jeff; Linville, Deanna; Tuttle Shamblin, Abby F.; Ball, David

2012-01-01

A handful of clinical trials have concluded that conjoint couples treatment for intimate partner violence is safe and at least as effective as conventional batterer intervention programs, yet very few researchers have explored couples' perspectives on conjoint treatment. Using qualitative narrative analysis methodology, the researchers conducted…

Review of HIV Pre exposure prophylaxis (PrEP) and example of HIV PrEP Toolkit

DTIC Science & Technology

2017-08-28

Research Division may pay for your basic journal publishing charges (to include costs for tables and black and white photos). We cannot pay for...USAF, BSC Director, Clinical Investigations & Research Support Warrior Medics - Mission Ready Patient Focused PROCESSING OF PROFESSIONAL MEDICAL...SGS O&M); SGS R&D: Tri-Service Nursing Research Program (TSNRP); Defense Medical Research & Development Program (DMRDP); NIH; Congressionally

The experience of Australian project leaders in encouraging practitioners to adopt research evidence in their clinical practice.

PubMed

Henderson, Amanda J; Davies, Jan; Willet, Michaela R

2006-11-01

This paper describes a qualitative program evaluation which sought to identify factors that either assist or impede the adoption of clinical evidence in everyday practice. Thirteen Australian projects were funded in a competitive grant program to adopt innovative strategies to improve the uptake of research evidence in everyday clinical practice. Project leaders' reports were analysed to collate common themes related to 1) critical elements in successful application of research knowledge, 2) barriers to implementing evidence, and 3) lessons for other organisations that might implement a similar project. Despite the diversity of the methods used to establish projects and the range of topics and clinical settings, many similarities were identified in the perceived critical success elements, barriers, and lessons for adopting clinical evidence. Eighteen themes emerged across the data including: leadership support; key stakeholder involvement; practice changes; communication; resources; education of staff; evaluation of outcomes; consumers; knowledge gaps; adoption/implementing staff; access to knowledge; risk assessment; collaboration; effectiveness of clinical research evidence; structure/organisation; cultural barriers; previous experiences; and information technology. Leaders of projects to adopt evidence in clinical practice identified barriers, critical success elements and lessons that impacted on their projects. A range of influences on the adoption of evidence were identified, and this knowledge can be used to assist others undertaking similar projects.

National survey of psychotherapy training in psychiatry, psychology, and social work.

PubMed

Weissman, Myrna M; Verdeli, Helen; Gameroff, Marc J; Bledsoe, Sarah E; Betts, Kathryn; Mufson, Laura; Fitterling, Heidi; Wickramaratne, Priya

2006-08-01

Approximately 3% of the US population receives psychotherapy each year from psychiatrists, psychologists, or social workers. A modest number of psychotherapies are evidence-based therapy (EBT) in that they have been defined in manuals and found efficacious in at least 2 controlled clinical trials with random assignment that include a control condition of psychotherapy, placebo, pill, or other treatment and samples of sufficient power with well-characterized patients. Few practitioners use EBT. To determine the amount of EBT taught in accredited training programs in psychiatry, psychology (PhD and PsyD), and social work and to note whether the training was elective or required and presented as a didactic (coursework) or clinical supervision. A cross-sectional survey of a probability sample of all accredited training programs in psychiatry, psychology, and social work in the United States. Responders included training directors (or their designates) from 221 programs (73 in psychiatry, 63 in PhD clinical psychology, 21 in PsyD psychology, and 64 in master's-level social work). The overall response rate was 73.7%. Main Outcome Measure Requiring both a didactic and clinical supervision in an EBT. Although programs offered electives in EBT and non-EBT, few required both a didactic and clinical supervision in EBT, and most required training was non-EBT. Psychiatry required coursework and clinical supervision in the largest percentage of EBT (28.1%). Cognitive behavioral therapy was the EBT most frequently offered and required as a didactic in all 3 disciplines. More than 90% of the psychiatry training programs were complying with the new cognitive behavior therapy requirement. The 2 disciplines with the largest number of students and emphasis on clinical training-professional clinical psychology (PsyD) and social work-had the largest percentage of programs (67.3% and 61.7%, respectively) not requiring a didactic and clinical supervision in any EBT. There is a considerable gap between research evidence for psychotherapy and clinical training. Until the training programs in the major disciplines providing psychotherapy increase training in EBT, the gap between research evidence and clinical practice will remain.

DHEW Research, Service, and Training Programs in Hearing, Speech, and Language: A Summary of Areas of Interest, Funding Mechanisms, Review Processes, and Information Sources.

ERIC Educational Resources Information Center

Kaplan, Harriet, Comp.; Lloyd, Lyle L., Comp.

Programs of agencies within the Department of Health, Education, and Welfare that support research, training, and clinical service projects in hearing, speech, and language development are reviewed. Information on each program usually includes areas of communication development and disorders specific to each agency; the funding mechanism used by…

42 CFR 68a.10 - What does an individual have to do in return for loan repayments received under the CR-LRP?

Code of Federal Regulations, 2010 CFR

2010-10-01

...) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS (CR-LRP) § 68a.10... must agree to be engaged in approved clinical research, as employees of the NIH, for a minimum initial...

A Mixed Methods Study Exploring Strengths-Based Mentoring in Clinical Practice and Student Teacher Development

ERIC Educational Resources Information Center

Moehle, Matthew R.

2011-01-01

As teacher education programs further emphasize clinical experiences, the role of university student teaching supervisor becomes increasingly important, as does research on supervision practices. Practitioners and researchers in the fields of positive psychology, management, and teacher education have argued that mentors who employ characteristics…

Disparities in Oral Health

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Bottled Water and Fluoride

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Infant Formula and Fluorosis

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

New clinical program will study metastatic colorectal cancer in viable patient tissue samples | Center for Cancer Research

Cancer.gov

Jonathan Hernandez, M.D., Investigator in the Thoracic and Gastrointestinal Oncology Branch, has established a new clinical program to understand how metastases form, which may yield insights into how to treat or even prevent them. The program will conduct first-of-their-kind studies with tumor-containing liver that is kept alive outside of the body after it is removed from a patient. Read more…

The Community Mentorship Program: Providing Community-Engagement Opportunities for Early-Stage Clinical and Translational Scientists to Facilitate Research Translation

PubMed Central

Patino, Cecilia M.; Kubicek, Katrina; Robles, Marisela; Kiger, Holly; Dzekov, Jeanne

2016-01-01

Problem A goal of the Southern California Clinical and Translational Science Institute (SC-CTSI) at the University of Southern California (USC) and Children's Hospital Los Angeles is to train early-stage clinical translational scientists (CTSs) to conduct research that improves the health of diverse communities. This goal aligns well with the Institute of Medicine's recommendations emphasizing community engagement in biomedical research that facilitates research translation. The Community Mentorship Program (CMP), created to complement community-engaged research (CER) didactics, matches CTSs with community mentors who help CTSs identify and complete community-engaged experiences that inform their research. Approach The CMP was piloted in 2013-2015 by the SC-CTSI Workforce Development and Community-Engagement cores. The CMP team matched three CTSs (assistant professors pursuing mentored career development awards, two with CER experience) with mentors at community-based organizations (CBOs) aligned with their research interests. Each mentor–mentee pair signed a memorandum of understanding. The CMP team checked in regularly, monitoring progress and addressing challenges in CTSs’ completion of their community-engaged experience. Outcomes All pairs completed at least one community-engaged activity informing the CTS's research. In exit interviews, the CTSs and CBO mentors expressed satisfaction with the program and stated they would continue to work together. The CTSs reported the program provided opportunities to develop networks outside academia, build trust within the community, and receive feedback and learn from individuals in communities affected by their research. Next Steps The CMP will be expanded to include all eligible early-career CTSs and promoted for use in similar settings outside the SC-CTSI. PMID:27508342

Impact of Global Health Research Training on Scholarly Productivity: The Fogarty International Clinical Research Scholars and Fellows Program.

PubMed

Heimburger, Douglas C; Carothers, Catherine Lem; Blevins, Meridith; Warner, Tokesha L; Vermund, Sten H

2015-12-01

In the Fogarty International Clinical Research Scholars and Fellows (FICRS-F) Program, 536 U.S. and international doctoral and postdoctoral health profession students and trainees completed 1-year research training at research centers in low- and middle-income countries. To evaluate the Program's impact, we analyzed data gathered prospectively during the Program, from PubMed, and from a representative survey of alumni. Of 100 randomly selected respondents, 94 returned the survey. Reflecting the sources of funding, human immunodeficiency virus/acquired immunodeficiency syndrome was the focus of 47% of the projects, but research in noncommunicable diseases (NCDs) and dual infection/NCD-related topics increased over time. Among the first 1,617 alumni publications, output was associated positively with being an international versus U.S. trainee, a postdoctoral Fellow versus predoctoral Scholar, and accumulation of more years post-training (all P < 0.001). Fellows were first author on a higher proportion of their articles than were Scholars (P < 0.001), and U.S. trainees were more often first author than international trainees (P = 0.04). Survey respondents had submitted 117 grant applications, and 79 (67.5%) had been funded. The FICRS-F Program yielded substantial research productivity in the early post-training years. Research outputs and impact will increase over time as alumni careers mature and they gain research independence and assume leadership positions. © The American Society of Tropical Medicine and Hygiene.

Developing an understanding of research-based nursing pedagogy among clinical instructors: a qualitative study.

PubMed

Zakari, Nazik M A; Hamadi, Hanadi Y; Salem, Olfat

2014-11-01

Effective instruction is imperative to the learning process of clinical nursing instructors. Faculty members are required to provide high-quality teaching and training by using new ways of teaching pedagogical methods to clinical instructors, which have transformed pedagogies from an exclusive clinical model to a holistic model. The purpose of this study was to explore clinical instructors' use of planning, implementation, feedback loops, and reflection frameworks to apply research-based teaching and to examine the pedagogy used during field experience. Data for the qualitative study were obtained from twenty purposefully sampled clinical teachers (n=20) via lists of questioned instructional practices and discussions, semi-structured interviews, observational notes, field notes, and written reflections. Data were analyzed by using a triangulation method to ensure trustworthiness, credibility, and reliability. Three main themes emerged regarding the use of research-based teaching strategies: the need for learning about research-based pedagogy, support mechanisms to implement innovative teaching strategies, and transitioning from nursing student to nursing clinical instructors. It has been well documented that the nursing profession faces a serious shortage of nursing faculty, impacting the quality of clinical teaching. Developing clinical instructor programs to give students opportunities to select instructor pathways, focusing on knowledge promoting critical thinking and life-long professional development, is essential. Nursing colleges must collaborate by using a partnership model to achieve competency in planning, implementation, feedback loops, and reflection. Applying research-based clinical teaching requires the development of programs that integrate low-fidelity simulation and assisted instruction through the use of computers in Nursing Colleges. Copyright © 2014 Elsevier Ltd. All rights reserved.

Tenure Eligible/Tenure Track Investigator | Center for Cancer Research

Cancer.gov

The HIV and AIDS Malignancy Branch (HAMB), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), is a national leader in research in the cancers associated with HIV/AIDS, in the development of therapies for HIV infection, and in oncogenic viruses.  We are seeking a tenure-eligible or tenure-track investigator in the field of HIV–related malignancies or viral oncogenesis.  It is anticipated that the investigator will establish an independent translational research program targeted to the study of the treatment, pathogenesis, and/or prevention of viral-induced or other HIV-associated tumors. The program can be primarily clinical, laboratory-based, or a combination of the two, and can also include animal model studies.  There is the potential to interface with a strong existing clinical research program. Potential areas of focus may include, but are not limited to, therapies for HIV malignancies, including novel immunologic approaches; viral oncogenesis; pathogenesis of HIV-associated malignancies; and virus host interactions, including immunologic interactions. 

Improving performance in golf: current research and implications from a clinical perspective.

PubMed

Evans, Kerrie; Tuttle, Neil

2015-01-01

Golf, a global sport enjoyed by people of all ages and abilities, involves relatively long periods of low intensity exercise interspersed with short bursts of high intensity activity. To meet the physical demands of full swing shots and the mental and physical demands of putting and walking the course, it is frequently recommended that golfers undertake golf-specific exercise programs. Biomechanics, motor learning, and motor control research has increased the understanding of the physical requirements of the game, and using this knowledge, exercise programs aimed at improving golf performance have been developed. However, while it is generally accepted that an exercise program can improve a golfer's physical measurements and some golf performance variables, translating the findings from research into clinical practice to optimise an individual golfer's performance remains challenging. This paper discusses how biomechanical and motor control research has informed current practice and discusses how emerging sophisticated tools and research designs may better assist golfers improve their performance.

Improving performance in golf: current research and implications from a clinical perspective

PubMed Central

Evans, Kerrie; Tuttle, Neil

2015-01-01

Golf, a global sport enjoyed by people of all ages and abilities, involves relatively long periods of low intensity exercise interspersed with short bursts of high intensity activity. To meet the physical demands of full swing shots and the mental and physical demands of putting and walking the course, it is frequently recommended that golfers undertake golf-specific exercise programs. Biomechanics, motor learning, and motor control research has increased the understanding of the physical requirements of the game, and using this knowledge, exercise programs aimed at improving golf performance have been developed. However, while it is generally accepted that an exercise program can improve a golfer's physical measurements and some golf performance variables, translating the findings from research into clinical practice to optimise an individual golfer's performance remains challenging. This paper discusses how biomechanical and motor control research has informed current practice and discusses how emerging sophisticated tools and research designs may better assist golfers improve their performance. PMID:26537808

Postdoctoral Fellows | Center for Cancer Research

Cancer.gov

The Oncogenomics section of the Genetics Branch is a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of utilizing genomics to develop novel immunotherapies for cancer. Our group is applying high throughput applied genomics methods including single cell RNAseq, single cell TCR sequencing, DNA sequencing, CRISPR/Cas9, bioinformatics combined with T cell based therapeutics to identify and develop novel immunotherapeutics for human cancer. We work with other investigators within the intramural program as well as industrial and pharmaceutical partners to rapidly translate our findings to the clinic. The program takes advantage of the uniqueness of the National Cancer Institute, (NCI), Center for Cancer Research (CCR) intramural program in that it spans high-risk basic discovery research in immunology, genomics and tumor biology, through preclinical translational research, to paradigm-shifting clinical trials. The position is available immediately. The appointment duration is up to 5 years. Stipends are commensurate with education and experience. Additional information can be found on Dr. Khan’s profile page: https://ccr.cancer.gov/Genetics-Branch/javed-khan

[Development and effects of emotional intelligence program for undergraduate nursing students: mixed methods research].

PubMed

Lee, Oi Sun; Gu, Mee Ock

2014-12-01

This study was conducted to develop and test the effects of an emotional intelligence program for undergraduate nursing students. The study design was a mixed method research. Participants were 36 nursing students (intervention group: 17, control group: 19). The emotional intelligence program was provided for 4 weeks (8 sessions, 20 hours). Data were collected between August 6 and October 4, 2013. Quantitative data were analyzed using Chi-square, Fisher's exact test, t-test, repeated measure ANOVA, and paired t-test with SPSS/WIN 18.0. Qualitative data were analyzed using content analysis. Quantitative results showed that emotional intelligence, communication skills, resilience, stress coping strategy, and clinical competence were significantly better in the experimental group compared to the control group. According to the qualitative results, the nursing students experienced improvement in emotional intelligence, interpersonal relationships, and empowerment, as well as a reduction in clinical practice stress after participation in the emotional intelligence program. Study findings indicate that the emotional intelligence program for undergraduate nursing students is effective and can be recommended as an intervention for improving the clinical competence of undergraduate students in a nursing curriculum.

The value of biomedical research training for veterinary anatomic and clinical pathologists.

PubMed

Sharkey, L C; Simpson, R M; Wellman, M L; Craig, L E; Birkebak, T A; Kock, N D; Miller, M A; Harris, R K; Munson, L

2012-07-01

Veterinary pathologists traditionally have been actively engaged in research as principal investigators and as collaborators. Pathologists frequently obtain advanced training in research; however, it appears that in the last 10 years there has been a reversal of a previous trend toward increasing numbers of pathologists obtaining PhD degrees. This has arisen despite an established shortage of veterinarians engaged in research. This article evaluates the benefits of research training for individual pathologists, including a wide spectrum of professional opportunities and additional skill development beyond that usually provided by diagnostic pathology training alone. Various training models are discussed, including combined and sequential diagnostic residency and research degree training as well as the nondegree research fellowship programs more commonly pursued in human medicine. Best-practice recommendations for program infrastructure, mentorship, time management, and a team approach to research and research training are advocated to facilitate the development of successful programs and to encourage a continued emphasis on integrated training for pathologists as both clinical diagnosticians and experimentalists. This article is intended to help prospective and active pathology trainees, their mentors, and educational administrators optimize opportunities to ensure the future vitality of veterinary pathologists, and their contributions, in basic and applied research.

Patient Care Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive, dedicated clinical research, study coordination, and administrative support to the National Cancer Institute’s (NCI’s), Office of the Clinical Director/Medical Oncology Service, Hematology Oncology Fellowship located at the National Institutes of Health (NIH) in Bethesda, Maryland. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Patient Care Coordinator III (PCC III) provides administrative services, as well as patient care coordination. Responsibilities will include: Acts as a liaison between fellows and fellowship director, research nurses and teams, clinic staff and other departments. Communicates with various clinical administrative support offices/clinics/diagnostic centers concerning scheduling of patient appointments, new and existing work scopes and clinical protocols (Surgery, X-ray, etc.). Consults with the fellow and patient, chooses the appropriate appointment, and enters ID and demographic data supplied by patient to secure an appointment in order to update clinic and physician schedules. Composes correspondence on various administrative issues including patient letters and notices to the patient’s home and physicians. Provides patients with information about their appointments, including medical materials the patient will need to bring, dates and times, clinic information, hospital maps and appropriate travel and hotel information. Arranges Admission Travel Voucher (ATV) travel, including lodging, meals and direct bill requests and enters data in the ATV system daily. Obtains up-to-date patient records and other pertinent information prior to patient appointments or admission. Maintains a roster of all patients and tracks their appointments. Attends weekly meetings and schedules surgeries and all clinic visits. Helps coordinate new patient screening appointments between protocol investigators and the outpatient clinic scheduling staff. Enters/updates clinic and/or physician appointment schedule availability into the central appointment computer. Maintains the patient database, patient education folders and status board for clinic patients. Answers incoming calls and routes to appropriate staff. Designs and sets up filing systems and office procedures. Files routine patient information, tests, reports, etc. into patient research records. Maintains relevant documents and e-documents that are easily accessible for reference. This position will be located in Bethesda, Maryland.

An Outline of a Proposed Five- plus Three-Year Combined Undergraduate-Master's Degree for Clinical Medicine Majors at Nanjing Medical University

ERIC Educational Resources Information Center

Gao, Xing-Ya; Yu, Rong-Bin; Shen, Hong-Bing; Chen, Qi

2014-01-01

To build an effective model to train excellent doctors, Nanjing Medical University has proposed a five- plus three-year combined undergraduate-master's clinical medicine degree program. The program integrates undergraduate education, the education of research students, and standardized doctor residency training into a single system, allowing…

Private Well Water and Fluoride

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Bench to Bedside: The Effectiveness of a Professional Development Program Focused on Biomedical Sciences and Action Research

PubMed Central

Barnes, Marianne B.; Barnes, Lehman W.; Cooper, Lou Ann; Bokor, Julie R.; Koroly, Mary Jo

2017-01-01

A three-year, National Institutes of Health-funded residential project at a southeastern research university immersed 83 secondary science teachers in a summer institute called “Bench to Bedside.” Teachers were provided with knowledge, skills, experiences, and incentives to improve their science teaching and increase their awareness of scientific processes, technologies, and careers by examining the translational medicine continuum of basic to clinical research. This was done with the help of medical school researchers, clinical personnel, biotechnology entrepreneurs, program mentors, and prior year participants. A critical component of the institute was the preparation and implementation of an action research project that reflected teachers’ newly acquired knowledge and skills. Action research proposals were critiqued by project team members and feedback provided prior to action research implementation in schools during the following year. Teachers shared their action research with colleagues and project team at a symposium and online as a critical step in networking the teachers. Results of a mixed methods program evaluation strategy indicate that the program produced significant gains in teachers’ confidence to explain advanced biosciences topics, development of action research skills, and formation of a statewide biosciences network of key stakeholders. Constraints of time, variation in teacher content and action research background, technology availability, and school-related variables, among others, are discussed. PMID:29733086

WE-G-BRB-04: Leveraging Innovation to Design Future Clinical Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Michalski, J.

Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

The Munroe-Meyer Approach: Continuous Integration of Didactic Instruction, Research, and Clinical Practice.

PubMed

Zangrillo, Amanda N; Warzak, William J; Volkert, Valerie M; Valleley, Rachel J; Shriver, Mark D; Rodriguez, Nicole M; Roberts, Holly J; Piazza, Cathleen C; Peterson, Kathryn M; Milnes, Suzanne M; Menousek, Kathryn M; Mathews, Terri L; Luczynski, Kevin C; Kupzyk, Sara S; Kuhn, Brett R; Higgins, William J; Grennan, Allison O; Greer, Brian D; Fisher, Wayne W; Evans, Joseph H; Allen, Keith D

2016-05-01

Increased demand for applied behavior analysis (ABA) services has increased the need for additional masters-level practitioners and doctoral-level academicians and clinical directors. Based on these needs, the University of Nebraska Medical Center's (UNMC) Munroe-Meyer Institute has developed a PhD program. The academic structure at UNMC allowed us to create our PhD program in a relatively quick and efficient manner. Our PhD program has many unique features, including (a) close integration of didactic instruction with clinical and research training provided by leading experts in ABA in which students immediately apply concepts introduced in the classroom during coordinated clinical and research practica; (b) structured grant writing training in which students learn to write and submit an NIH-level grant; (c) financial support in the form of a stipend of $23,400 per year, free health benefits, and a full-tuition waiver for up to 12 credits per semester for UNMC courses (a benefits package worth approximately $50,000 per year for an out-of-state student); and (d) encouragement and financial support to present papers at local, regional, and national behavior analysis conferences.

Culturally Competent Practice: A Mixed Methods Study Among Students, Academics and Alumni of Clinical Psychology Master’s Programs in the Netherlands

PubMed Central

Geerlings, Lennie R. C.; Thompson, Claire L.; Kraaij, Vivian; Keijsers, Ger P. J.

2018-01-01

This is the first research into preparation for multicultural clinical psychology practice in Europe. It applies the theory of multicultural counselling competency (MCC) to a case study in the Netherlands. It was hypothesized that cross-cultural practice experience, identification as a cultural minority, and satisfaction with cultural training was associated with MCC. The Multicultural Awareness Knowledge and Skills Survey was completed by 106 participants (22 students, 10 academics, 74 alumni) from clinical psychology masters’ programs. MANOVA detected a main effect of cross-cultural experience on MCC for all groups and universities. The data were enriched with exploratory qualitative data from 14 interviews (5 students, 5 academics, 4 alumni). Interpretative Phenomenological Analysis revealed three themes: limitations of clinical psychology, strategies for culturally competent practice, and strategies for cultural competency development. These outcomes suggest that cultural competency continues to require attention in master’s programs. The paper makes recommendations for further research enquiry related to training clinical psychologists to practice in Europe’s multicultural societies. PMID:29899800

Challenges With Research Contract Negotiations in Community-Based Cancer Research.

PubMed

Thompson, Michael A; Hurley, Patricia A; Faller, Bryan; Longinette, Jean; Richter, Katie; Stewart, Teresa L; Robert, Nicholas

2016-06-01

Community-based research programs face many barriers to participation in clinical trials. Although the majority of people with cancer are diagnosed and treated in the community setting, only roughly 3% are enrolled onto clinical trials. Research contract and budget negotiations have been consistently identified as time consuming and a barrier to participation in clinical trials. ASCO's Community Research Forum conducted a survey about specific challenges of research contract and budget negotiation processes in community-based research settings. The goal was to ultimately identify potential solutions to these barriers. A survey was distributed to 780 community-based physician investigators and research staff. The survey included questions to provide insight into contract and budget negotiation processes and perceptions about related barriers. A total of 77% of the 150 respondents acknowledged barriers in the process. Respondents most frequently identified budget-related issues (n = 133), inefficiencies in the process (n = 80), or legal review and negotiation issues (n = 70). Of the respondents, 44.1% indicated that contract research organizations made the contract negotiations process harder for their research program, and only 5% believed contract research organizations made the process easier. The contract negotiations process is perceived to be impeded by sponsors through underestimation of costs, lack of flexibility with the contract language, and excessive delays. Improving clinical trial activation processes and reducing inefficiencies would be beneficial to all interested stakeholders, including patients who may ultimately stand to benefit from participation in clinical trials. The following key recommendations were made: standardization of contracts and negotiation processes to promulgate transparency and efficiencies, improve sponsor processes to minimize burden on sites, create and promote use of contract templates and best practices, and provide education and consultation. Copyright © 2016 by American Society of Clinical Oncology.

Interactive Voice/Web Response System in clinical research

PubMed Central

Ruikar, Vrishabhsagar

2016-01-01

Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc. PMID:26952178

Interactive Voice/Web Response System in clinical research.

PubMed

Ruikar, Vrishabhsagar

2016-01-01

Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc.

Early Experience with a Brief, Multimodal, Multidisciplinary Treatment Program for Fibromyalgia

PubMed Central

Vincent, Ann; Whipple, Mary O.; Oh, Terry H.; Guderian, Janet A.; Barton, Debra L.; Luedtke, Connie A.

2014-01-01

Fibromyalgia is a complex, heterogeneous disorder for which a multidisciplinary individualized approach is currently advocated. We executed a 1 week multidisciplinary fibromyalgia clinical program with 7 patients, based on our previous experience with our existing 1.5 day multidisciplinary fibromyalgia program that has demonstrated both short- and long-term benefits. The current expanded program was not designed as a clinical study, but rather as a clinical feasibility assessment and was multidisciplinary in nature, with cognitive behavioral therapy, activity pacing and graded exercise therapy as major components. We assessed changes in individual patients at 1 week and 3 months following the program utilizing validated self-report measures of pain, fatigue, and self-efficacy. All patients indicated at least small improvements in pain and physical symptoms both at 1 week and 3 months and all but one patient showed improvement in self-efficacy at 1 week and 3 months. Similar trends were observed for fatigue. Based on our early clinical experience, we conclude that the 1 week multidisciplinary fibromyalgia program is logistically feasible and has potential for clinical efficacy. Further research is needed and is planned to test the clinical efficacy of this program and compare it with other interventions. PMID:24315246

Care of the elderly program at the University of Alberta

PubMed Central

Charles, Lesley; Dobbs, Bonnie; Triscott, Jean; McKay, Rhianne

2014-01-01

Abstract Problem addressed The population is aging rapidly and there are implications for health care delivery in the face of few physicians specializing in care of the elderly (COE). Objective of program To train physicians wishing to provide COE services. Program description The COE program at the University of Alberta in Edmonton is an enhanced skills diploma program lasting 6 months to 1 year, with core program requirements including geriatric inpatient care, geriatric psychiatry, ambulatory care, continuing care, and outreach. There is a longitudinal clinic component and a research project requirement. The program is designed to cover the 85 core competencies in the CanMEDS– Family Medicine roles. Conclusion There is a need for COE physicians to provide clinical care as well as fill educational, administrative, and research roles to meet the health care needs of medically complex seniors. These physicians require alternative funding and a departmental home within a university if they are to provide an academic service. PMID:25551143

Cancer Therapy Evaluation Program | Office of Cancer Genomics

Cancer.gov

The Cancer Therapy Evaluation Program (CTEP) seeks to improve the lives of cancer patients by finding better treatments, control mechanisms, and cures for cancer. CTEP funds a national program of cancer research, sponsoring clinical trials to evaluate new anti-cancer agents.

42 CFR 68a.9 - What loans qualify for repayment?

Code of Federal Regulations, 2012 CFR

2012-10-01

..., INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR... Service Award Program, Public Health and National Health Service Corps Scholarship Training Program... and commercial educational loans obtained by participants for the following: (1) Undergraduate...

42 CFR 68a.9 - What loans qualify for repayment?

Code of Federal Regulations, 2011 CFR

2011-10-01

..., INTERNSHIPS, TRAINING NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR... Service Award Program, Public Health and National Health Service Corps Scholarship Training Program... and commercial educational loans obtained by participants for the following: (1) Undergraduate...

An innovative portfolio of research training programs for medical students.

PubMed

Zier, Karen; Wyatt, Christina; Muller, David

2012-12-01

Medical student education continues to evolve, with an increasing emphasis on evidence-based decision making in clinical settings. Many schools are introducing scholarly programs to their curriculum in order to foster the development of critical thinking and analytic skills, encourage self-directed learning, and develop more individualized learning experiences. In addition, participation in rigorous scholarly projects teaches students that clinical care and research should inform each other, with the goal of providing more benefit to patients and society. Physician-scientists, and physicians who have a better appreciation of science, have the potential to be leaders in the field who will deliver outstanding clinical care, contribute new knowledge, and educate their patients.

76 FR 55074 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-06

... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA Related Construction...

Use of clinical movement screening tests to predict injury in sport

PubMed Central

Chimera, Nicole J; Warren, Meghan

2016-01-01

Clinical movement screening tests are gaining popularity as a means to determine injury risk and to implement training programs to prevent sport injury. While these screens are being used readily in the clinical field, it is only recently that some of these have started to gain attention from a research perspective. This limits applicability and poses questions to the validity, and in some cases the reliability, of the clinical movement tests as they relate to injury prediction, intervention, and prevention. This editorial will review the following clinical movement screening tests: Functional Movement Screen™, Star Excursion Balance Test, Y Balance Test, Drop Jump Screening Test, Landing Error Scoring System, and the Tuck Jump Analysis in regards to test administration, reliability, validity, factors that affect test performance, intervention programs, and usefulness for injury prediction. It is important to review the aforementioned factors for each of these clinical screening tests as this may help clinicians interpret the current body of literature. While each of these screening tests were developed by clinicians based on what appears to be clinical practice, this paper brings to light that this is a need for collaboration between clinicians and researchers to ensure validity of clinically meaningful tests so that they are used appropriately in future clinical practice. Further, this editorial may help to identify where the research is lacking and, thus, drive future research questions in regards to applicability and appropriateness of clinical movement screening tools. PMID:27114928

A clinical refresher course for medical scientist trainees.

PubMed

Swartz, Talia H; Lin, Jenny J

2014-06-01

MD-PhD students experience a prolonged hiatus away from clinical medicine during their laboratory research phase and some have experienced difficulty transitioning back to clinical medicine during clerkship years. We developed a clinical refresher program that serves to rebuild clinical skills prior to re-entering the clinical clerkship years. A nine-week program includes a combination of didactic and practical review in history, physical exam, presentation and clinical reasoning skills. The program uses multiple modalities from classroom-based activities to patient care encounters and includes a final assessment using standardized patients. After seven years of experience, we have made modifications that result in our students scoring comparably well on a standardized patient exam to their second-year medical student colleagues. By the end of the course, all students reported feeling more comfortable completing a history and physical examination and some improvement in preclinical knowledge base. Review of clerkship scores showed a higher percentage of MD-PhD students scoring Honors in a clerkship in years after course implementation as compared to years prior to course implementation. We describe a clinical refresher course for successfully retraining MD-PhD students to re-enter clinical medical training. It is effective at restoring clinical skills to a level comparable to their medical student contemporaries and prepares them to rejoin the medical student class at the conclusion of their research phase.

Motivating medical students to do research: a mixed methods study using Self-Determination Theory.

PubMed

Rosenkranz, Sara K; Wang, Shaoyu; Hu, Wendy

2015-06-02

It is widely accepted that all medical graduates should understand the uses and methods of rigorous research, with a need to promote research to graduates who will pursue an academic career. This study aimed to explore, identify and explain what motivates and demotivates medical students to do research. A convergent parallel mixed methods study was conducted. Cross-sectional quantitative survey data (n = 579) and qualitative semi-structured interview findings (n = 23) data were separately collected and analysed. Informed by Self-Determination Theory (SDT), quantitative and qualitative findings were integrated to develop a model for the factors associated with medical students' expressed motivation to do research, and related to clinical and research learning activities at different stages in an undergraduate medical program. Only 7.5% of students had research experience prior to entering the program. Survey results revealed that students who had experienced exposure to the uncertainties of clinical practice through clerkships (Pre-Clinical (48%) vs Clinical Years (64%), p < 0.001), and a sense of achievement through supported compulsory research activities which were conducted as a team (Pre- Community Research (51%) vs Post-Community Research (66%), p < 0.001), were more likely to view future research activities positively. When integrated with qualitative findings using the three SDT domains of autonomy, competence and relatedness, eight major themes were identified: Self & Time, Career, Bureaucracy, Financial, Confidence, Clinical Relevance, Research as a Social Activity, and Personal Relevance. The findings suggest that motivation to do research is associated with increasing internalization of intrinsic motivators; in particular those associated with competence (Confidence) and relatedness (Clinical Relevance, Research as a Social Activity). SDT is useful for understanding the motivation of individuals and how curriculum can be designed to optimise motivation. Study findings suggest that well supported compulsory research activities that incorporate group learning and elements of choice may promote motivation to do research, and potentially, careers in research, even in a research naive student body.

NCI Community Oncology Research Program (NCORP) | Division of Cancer Prevention

Cancer.gov

The NCI Community Oncology Research Program (NCORP) is a national network of cancer care investigators, providers, academia, and other organizations that care for diverse populations in health systems. View the list of publications from NCORP. | Clinical Trials network of cancer care professionals who care for diverse populations across the U.S.

Training Partnership Dyads for Community-Based Participatory Research: Strategies and Lessons Learned From the Community Engaged Scholars Program

PubMed Central

Andrews, Jeannette O.; Cox, Melissa J.; Newman, Susan D.; Gillenwater, Gwen; Warner, Gloria; Winkler, Joyce A.; White, Brandi; Wolf, Sharon; Leite, Renata; Ford, Marvella E.; Slaughter, Sabra

2014-01-01

This article describes the development, implementation, evaluation framework, and initial outcomes of a unique campus–community training initiative for community-based participatory research (CBPR). The South Carolina Clinical & Translational Research Center for Community Health Partnerships, which functions as the institution’s Clinical Translational and Science Award Community Engagement Program, leads the training initiative known as the Community Engaged Scholars Program (CES-P). The CES-P provides simultaneous training to CBPR teams, with each team consisting of at least one community partner and one academic partner. Program elements include 12 months of monthly interactive group sessions, mentorship with apprenticeship opportunities, and funding for a CBPR pilot project. A modified RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework guides the process, impact, and outcome evaluation plan. Lessons learned include challenges of group instruction with varying levels of readiness among the CBPR partners, navigating the institutional review board process with community co-investigators, and finding appropriate academic investigators to match community research interests. Future directions are recommended for this promising and unique dyadic training of academic and community partners. PMID:23091303

Mentoring Early-Career Faculty Researchers Is Important-But First "Train the Trainer".

PubMed

Sood, Akshay; Tigges, Beth; Helitzer, Deborah

2016-12-01

It has long been known that mentoring is critical to the success of junior faculty researchers. The controlled intervention study by Libby et al published in this issue of Academic Medicine demonstrates that institutional investment in a mentored research career development program for early-career faculty investigators provided significant long-term gains in grant productivity. Academic institutions hoping to replicate this program's success by launching similar mentoring programs for their junior faculty investigators will, however, find that the Achilles' heel lies in the scarcity of skilled research mentors and the relative lack of attention to and recognition of the importance of a supportive institutional climate for mentoring. It is essential, therefore, to begin by developing programs to "train the trainer" as well as programs and policies to support mentors. As a recent trial at 16 Clinical and Translational Science Award institutions demonstrated, competency-based, structured research mentor training can improve mentors' skills.In this Commentary, the authors offer a comprehensive two-pronged framework for mentor development with elements that address both individual mentoring competencies and the institutional climate for mentoring. The framework depicts the gaps, activities, and outcomes that a mentor development program can address. Activities directed at changing the institutional climate related to mentor development should complement training activities for individual mentors. The authors propose that employing this framework's approach to mentor development will lead to the desired impact: to increase the competence, productivity, and retention of a diverse clinical and translational research workforce.

Preventing Obesity in the Military Community (POMC): The Development of a Clinical Trials Research Network

PubMed Central

Spieker, Elena A.; Sbrocco, Tracy; Theim, Kelly R.; Maurer, Douglas; Johnson, Dawn; Bryant, Edny; Bakalar, Jennifer L.; Schvey, Natasha A.; Ress, Rachel; Seehusen, Dean; Klein, David A.; Stice, Eric; Yanovski, Jack A.; Chan, Linda; Gentry, Shari; Ellsworth, Carol; Hill, Joanne W.; Tanofsky-Kraff, Marian; Stephens, Mark B.

2015-01-01

Obesity impacts the U.S. military by affecting the health and readiness of active duty service members and their families. Preventing Obesity in Military Communities (POMC) is a comprehensive research program within Patient Centered Medical Homes (PCMHs) in three Military Training Facilities. This paper describes three pilot randomized controlled trials that target critical high risk periods for unhealthy weight gain from birth to young adulthood: (1) pregnancy and early infancy (POMC-Mother-Baby), (2) adolescence (POMC-Adolescent), and (3) the first tour of duty after boot camp (POMC-Early Career). Each study employs a two-group randomized treatment or prevention program with follow up. POMC offers a unique opportunity to bring together research and clinical expertise in obesity prevention to develop state-of-the-art programs within PCMHs in Military Training Facilities. This research builds on existing infrastructure that is expected to have immediate clinical benefits to DoD and far-reaching potential for ongoing collaborative work. POMC may offer an economical approach for widespread obesity prevention, from conception to young adulthood, in the U.S. military as well as in civilian communities. PMID:25648176

Patient Care Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive, dedicated clinical research, study coordination, and administrative support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Urologic Oncology Branch (UOB) located at the National Institutes of Health (NIH) in Bethesda, Maryland. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Patient Care Coordinator III (PCC III) provides administrative services, as well as patient care coordination. Responsibilities will include: Communicates with various clinical administrative support offices/clinics/diagnostic centers concerning scheduling of patient appointments, new and existing work scopes and clinical protocols (Surgery, X-ray, etc.). Consults with the patient, chooses the appropriate appointment, and enters ID and demographic data supplied by patient to secure an appointment in order to update clinic and physician schedules. Composes correspondence on various administrative issues including patient letters and notices to the patient’s home and physicians. Provides patients with information about their appointments, including medical materials the patient will need to bring, dates and times, clinic information, hospital maps and appropriate travel and hotel information. Arranges Admission Travel Voucher (ATV) travel, including lodging, meals and direct bill requests and enters data in the ATV system daily. Obtains up-to-date patient records and other pertinent information prior to patient appointments or admission. Maintains a roster of all patients and tracks their appointments. Attends weekly meetings and schedules surgeries and all clinic visits. Helps coordinate new patient screening appointments between protocol investigators and the outpatient clinic scheduling staff. Enters/updates clinic and/or physician appointment schedule availability into the central appointment computer. Maintains the patient database, patient education folders and status board for clinic patients. Answers incoming calls and routes to appropriate staff. Acts as a liaison between physicians, nursing staff and other departments. Collects outside CT scans and pathology slides, records arrival times, and completes appropriate requests to be read by NIH personnel. Delivers slides/blocks to pathology for review and films to the film library. Designs and sets up filing systems and office procedures. Files routine patient information, tests, reports, etc. into patient research records. Maintains relevant documents and e-documents that are easily accessible for reference. This position will be located in Bethesda, Maryland.

The Importance of Research during Pharmacy Residency Training

PubMed Central

Stranges, Paul M.; Burke, John M.; Micek, Scott; Pitlick, Matthew K.; Wenger, Philip

2015-01-01

Practice-related projects and pharmacy practice research are requirements to complete postgraduate pharmacy residency programs. Many residents will complete residencies without fully developing the skills needed to perform research required for new clinical and academic positions. Many studies have quantified successes and identified characteristics that may be associated with successful resident publication. There are many benefits to gaining research and publication skills during residency training for the resident, preceptor/mentors, and the residency program. Published works have also suggested approaches than can be taken to improve research within a residency program. The aims of this article are to discuss the publication rates of resident research projects, suggest ways to improve residency research, review benefits of residency research, and briefly review research training alternatives. PMID:26594260

Factors That Help and Hinder Scientific Training in Counseling and Clinical Psychology Students

ERIC Educational Resources Information Center

Marks, Margaret M.

2011-01-01

The purpose of this dissertation is to better understand scientific training within clinical and counseling psychology doctoral programs. A primary goal is to extend previous research by expanding the scientific training outcome variables from research interest and productivity to include additional characteristics of scientific mindedness such as…

Male Oncology Research and Education program for men at high risk for prostate cancer.

PubMed

Lorentz, J; Liu, S K; Vesprini, D

2018-04-01

Three groups of men are at high risk of developing prostate cancer: men with a strong family history of prostate cancer, men of West African or Caribbean ancestry, and men with a germline pathogenic variant in a prostate cancer-associated gene. Despite the fact that those men constitute a significant portion of the male population in North America, few recommendations for prostate cancer screening specific to them have been developed. For men at general population risk for prostate cancer, screening based on prostate-specific antigen (psa) has remained controversial despite the abundance of literature on the topic. As a result, recommendations made by major screening authorities are inconsistent (ranging from no psa screening to baseline psa screening at age 45), allowing physicians to pick and choose how to screen their patients. The Male Oncology Research and Education (more) program is an observational research program that serves as an academic platform for multiple research foci. For its participants, serum and dna are biobanked, medical information is collected, and contact for relevant research-related opportunities is maintained. This research program is paired with a specialized clinic called the more clinic, where men at high risk are regularly screened for prostate cancer in a standard approach that includes physical examination and serum psa measurement. In this article, we describe the goals, participant accrual to date, and projects specific to this unique program.

Highly effective cystic fibrosis clinical research teams: critical success factors.

PubMed

Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

2014-08-01

Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

Descriptive survey of Summer Genetics Institute nurse graduates in the USA.

PubMed

Hickey, Kathleen T; Sciacca, Robert R; McCarthy, Mary S

2013-03-01

The purpose of this study was to describe the clinical, research, educational, and professional activities that nurses are engaged in following participation in a 2 month intramural genetics training program. An online survey was administered in 2010 to graduates of the program sponsored by the US National Institute of Nursing Research from 2000 to 2009, in Bethesda, Maryland, USA. The electronic, voluntary survey was sent to 189 graduates via email. The survey included demographic characteristics, educational preparation, professional roles and responsibilities, and attitudes about genetic testing and privacy issues. Of the 95 graduates responding to the survey, 74% had doctorates and 70% were advanced practice nurses. All respondents reported incorporating genetics knowledge into daily clinical, academic, or research practices since completing the program, with 72% reporting being involved in genetically-focused research (52% with research funding), 32% incorporating genetics into patient care, and 79% providing genetics education. Respondents working in a hospital setting or academic institution were more likely to desire additional training in genetics. National Institute of Nursing Research graduates have successfully integrated genomics into a variety of nursing practices. © 2012 Wiley Publishing Asia Pty Ltd.

A case study of engaging hard-to-reach participants in the research process: Community Advisors on Research Design and Strategies (CARDS)®

PubMed Central

Kaiser, Betty L.; Thomas, Gay R.; Bowers, Barbara J.

2016-01-01

Lack of diversity among study participants in clinical research limits progress in eliminating health disparities. The engagement of lay stakeholders, such as patient or community advisory boards (CABs), has the potential to increase recruitment and retention of underrepresented groups by providing a structure for gathering feedback on research plans and materials from this target population. However, many CABs intentionally recruit prominent stakeholders who are connected to or comfortable with research and academia and thus may not accurately represent the perspectives of underrepresented groups who have been labeled hard-to-reach, including racial minorities and low-income or low-literacy populations. We developed a partnership between the University of Wisconsin-Madison School of Nursing and two community centers to deliberately engage hard-to-reach people in two lay advisory groups, the Community Advisors on Research Design and Strategies (CARDS)®. Community center staff recruited the CARDS® from center programs, including parenting and childcare programs, women’s support groups, food pantries, and senior meal programs. The CARDS® model differs from other CABs in its participants, processes, and outcomes. Since 2010, the CARDS® have met monthly with nurses and other researchers, helping them understand how research processes and the language, tone, appearance, and organization of research materials can discourage people from enrolling in clinical studies. We have successfully used the CARDS® model to bring hard-to-reach populations into the research process and have sustained their participation. The model represents a promising strategy for increasing the diversity of participants in clinical research. PMID:27686421

Building a bridge for nursing education and clinical care in Taiwan--using action research and Confucian tradition to close the gap.

PubMed

Yang, Wan-Ping; Chao, Co-Shi Chantal; Lai, Wei-Shu; Chen, Ching-Huey; Shih, Ya Lan; Chiu, Ge-Lin

2013-03-01

Nursing workplaces in Taiwan are unable to retain talent. An examination of this problem has revealed that the causes of this phenomenon are that nursing education fails to cultivate the skills that meet workplace requirements and that there are gap between nursing education and clinical practice. This paper is an action research that aims is to design educational programs that can close the gap between nursing education and clinical practice in Taiwan. In this action research project, 4 action cycles were used to design educational programs including concept mapping and focused discussion strategies. Participants were invited to join the research in three teaching hospitals and one university. Two groups of participants, student nurses (SN) and nursing staff personnel (NS), were sampled and invited to participate in the research. Participant observation, focus groups, and qualitative interviews were used to collect data. Qualitative data were not only profiled by content analysis, but they were also compared continuously between the two groups as well as between the 4 cycles. The qualitative data collected for the 135 participants were analysed. The themes of an effective nursing program were summarized. Many fundamental values of traditional Chinese education have gradually faded due to the Westernization of education. In this study, we discovered that Western educational models may play a critical role in improving traditionally taught nursing education programs. Copyright © 2012 Elsevier Ltd. All rights reserved.

Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial

DTIC Science & Technology

2017-03-21

FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...Center ATTN: DTIC-OA 8725 John J. Kingman Rd Fort Belvoir, VA 22060-6218 Submitted by: Jill M. Clark, MBA/HCM, CCRP, CCRC Senior Research ...Associate/ Research Manager Clinical Investigation Program Mike O’Callaghan Federal Medical Center (MOFMC) 4700 Las Vegas Blvd North, Bldg 1300, Room

Integration and Evaluation of Substance Abuse Research Education Training (SARET) into a Master of Social Work program.

PubMed

Tuchman, Ellen; Hanley, Kathleen; Naegle, Madeline; More, Frederick; Bereket, Sewit; Gourevitch, Marc N

2017-01-01

The Substance Abuse Research and Education Training (SARET) program is funded by the National Institutes of Drug Abuse in 2006 as a novel approach to spark interest in substance abuse research among medical, dental, nursing, and social work graduate students through a Web-based curriculum and research mentorships. This report presents the initial integration of the intervention in a Master of Social Work (MSW) program, the components of the program, and the mixed-methods evaluation of its effect on students' attitudes towards substance abuse research and treatment. SARET comprises 2 main components: stipend-supported research mentorships and a Web-based module series, consisting of 6 interactive, multimedia modules addressing core SA research topics, delivered via course curricula and in the research mentorships. An initial evaluation was designed to assess SARET's acceptability and short-term impact on participants' interest in SA research. The components of this Web-based curriculum evaluation include focus group feedback on the relevance of the modules to SW students, number of courses into which the modules were integrated with number of module completions, changes in interest in SA research associated with module completion. The full series of Web-based modules has been integrated across several courses in the social work curriculum, and social work students have become integral participants in the summer mentored research experience. One hundred eighteen students completed at least 1 module and 42 students completed all 6 modules. Neurobiology, Screening, and Epidemiology were the most widely viewed modules. Students reported positive impact on their vision of SA-related clinical care, more positive attitudes about conducting research, and in some cases, change in career. The SARET program's modules and summer mentored research increased clinical and research interest related to SUDs, as well as interprofessional attitudes among social work students. Participants have shown some early research success. Longer-term follow-up will enable us to continue to assess the effectiveness of the program.

76 FR 24890 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

....nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702...

75 FR 70934 - National Center For Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333; 93.702, ARRA...

76 FR 24500 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

[email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333...

75 FR 16816 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure; 93.306, 93.333; 93.702, ARRA Related Construction...

Partnership between CTSI and Business Schools Can Promote Best Practices for Core Facilities and Resources

PubMed Central

Reeves, Lilith; Dunn‐Jensen, Linda M.; Baldwin, Timothy T.; Tatikonda, Mohan V.

2013-01-01

Abstract Biomedical research enterprises require a large number of core facilities and resources to supply the infrastructure necessary for translational research. Maintaining the financial viability and promoting efficiency in an academic environment can be particularly challenging for medical schools and universities. The Indiana Clinical and Translational Sciences Institute sought to improve core and service programs through a partnership with the Indiana University Kelley School of Business. The program paired teams of Masters of Business Administration students with cores and programs that self‐identified the need for assistance in project management, financial management, marketing, or resource efficiency. The projects were developed by CTSI project managers and business school faculty using service‐learning principles to ensure learning for students who also received course credit for their participation. With three years of experience, the program demonstrates a successful partnership that improves clinical research infrastructure by promoting business best practices and providing a valued learning experience for business students. PMID:23919365

Partnership between CTSI and business schools can promote best practices for core facilities and resources.

PubMed

Reeves, Lilith; Dunn-Jensen, Linda M; Baldwin, Timothy T; Tatikonda, Mohan V; Cornetta, Kenneth

2013-08-01

Biomedical research enterprises require a large number of core facilities and resources to supply the infrastructure necessary for translational research. Maintaining the financial viability and promoting efficiency in an academic environment can be particularly challenging for medical schools and universities. The Indiana Clinical and Translational Sciences Institute sought to improve core and service programs through a partnership with the Indiana University Kelley School of Business. The program paired teams of Masters of Business Administration students with cores and programs that self-identified the need for assistance in project management, financial management, marketing, or resource efficiency. The projects were developed by CTSI project managers and business school faculty using service-learning principles to ensure learning for students who also received course credit for their participation. With three years of experience, the program demonstrates a successful partnership that improves clinical research infrastructure by promoting business best practices and providing a valued learning experience for business students. © 2013 Wiley Periodicals, Inc.

CAEP 2014 Academic Symposium: "How to make research succeed in your emergency department: How to develop and train career researchers in emergency medicine".

PubMed

Perry, Jeffrey J; Snider, Carolyn E; Artz, Jennifer D; Stiell, Ian G; Shaeri, Sedigheh; McLeod, Shelley; Le Sage, Natalie; Hohl, Corinne; Calder, Lisa A; Vaillancourt, Christian; Holroyd, Brian; Hollander, Judd E; Morrison, Laurie J

2015-05-01

We sought to 1) identify best practices for training and mentoring clinician researchers, 2) characterize facilitators and barriers for Canadian emergency medicine researchers, and 3) develop pragmatic recommendations to improve and standardize emergency medicine postgraduate research training programs to build research capacity. We performed a systematic review of MEDLINE and Embase using search terms relevant to emergency medicine research fellowship/graduate training. We conducted an email survey of all Canadian emergency physician researchers. The Society for Academic Emergency Medicine (SAEM) research fellowship program was analysed, and other similar international programs were sought. An expert panel reviewed these data and presented recommendations at the Canadian Association of Emergency Physicians (CAEP) 2014 Academic Symposium. We refined our recommendations based on feedback received. Of 1,246 potentially relevant citations, we included 10 articles. We identified five key themes: 1) creating training opportunities; 2) ensuring adequate protected time; 3) salary support; 4) infrastructure; and 5) mentorship. Our survey achieved a 72% (67/93) response rate. From these responses, 42 (63%) consider themselves clinical researchers (i.e., spend a significant proportion of their career conducting research). The single largest constraint to conducting research was funding. Factors felt to be positive contributors to a clinical research career included salary support, research training (including an advanced graduate degree), mentorship, and infrastructure. The SAEM research fellowship was the only emergency medicine research fellowship program identified. This 2-year program requires approval of both the teaching centre and each applying fellow. This program requires training in 15 core competencies, manuscript preparation, and submission of a large grant to a national peer-review funding organization. We recommend that the CAEP Academic Section create a process to endorse research fellowship/graduate training programs. These programs should include two phases: Phase I: Research fellowship/graduate training would include an advanced research university degree and 15 core learning areas. Phase II: research consolidation involves a further 1-3 years with an emphasis on mentorship and scholarship production. It is anticipated that clinician scientists completing Phase I and Phase II training at a CAEP Academic Section-endorsed site(s) will be independent researchers with a higher likelihood of securing external peer-reviewed funding and be able to have a meaningful external impact in emergency medicine research.

Association of research self-efficacy with medical student career interests, specialization, and scholarship: a case study.

PubMed

Bierer, S Beth; Prayson, Richard A; Dannefer, Elaine F

2015-05-01

This study used variables proposed in social cognitive career theory (SCCT) to focus the evaluation of a research curriculum at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (CCLCM). Eight cohorts of CCLCM medical students completed a web-based version of the six-scale Clinical Research Appraisal Inventory-Short Form (CRAI-SF) items at matriculation (n = 128) or graduation (n = 111) during 2009-2013. Parametric statistics were used to compare CRAI-SF scales to domains proposed in SCCT: trainees' characteristics (gender, training level, advanced degree), career interests, career intentions (medical specialty), and performance (peer-reviewed publications and required thesis topic). A number of lessons emerged in using theory to frame the evaluation of a complex educational program. Graduates rated their research self-efficacy significantly higher on all six CRAI-SF scales with large effect sizes (>.90) on five scales (Conceptualizing a Study, Study Design and Analysis, Responsible Research Conduct, Collaborating with Others, and Reporting a Study). Women and men did not have significantly different scores on CRAI-SF scales (p > .05), suggesting that the research program provides adequate supports for women students. Most thesis projects addressed clinical (36.9 %, n = 41) or translational (34.2 %, n = 38) research topics. The CRAI-SF discriminated between medical school matriculates and graduates, suggesting that research self-efficacy increases with mastery experiences. No significant relationships occurred between CRAI-SF scores and graduates' thesis topics or chosen clinical specialty. Correlations demonstrated significant relationships between graduates' perceptions of research self-efficacy and their interest in clinical research careers.

Reengineering the national clinical and translational research enterprise: the strategic plan of the National Clinical and Translational Science Awards Consortium.

PubMed

Reis, Steven E; Berglund, Lars; Bernard, Gordon R; Califf, Robert M; Fitzgerald, Garret A; Johnson, Peter C

2010-03-01

Advances in human health require the efficient and rapid translation of scientific discoveries into effective clinical treatments; this process, in turn, depends on observational data gathered from patients, communities, and public health research that can be used to guide basic scientific investigation. Such bidirectional translational science, however, faces unprecedented challenges due to the rapid pace of scientific and technological development, as well as the difficulties of negotiating increasingly complex regulatory and commercial environments that overlap the research domain. Further, numerous barriers to translational science have emerged among the nation's academic research centers, including basic structural and cultural impediments to innovation and collaboration, shortages of trained investigators, and inadequate funding.To address these serious and systemic problems, in 2006 the National Institutes of Health created the Clinical and Translational Science Awards (CTSA) program, which aims to catalyze the transformation of biomedical research at a national level, speeding the discovery and development of therapies, fostering collaboration, engaging communities, and training succeeding generations of clinical and translational researchers. The authors report in detail on the planning process, begun in 2008, that was used to engage stakeholders and to identify, refine, and ultimately implement the CTSA program's overarching strategic goals. They also discuss the implications and likely impact of this strategic planning process as it is applied among the nation's academic health centers.

Clinical and translational research in global health and emergency care: a research agenda.

PubMed

Runyon, Michael S; Sawe, Hendry R; Levine, Adam C; Pousson, Amelia; House, Darlene R; Agrawal, Pooja; Osei-Ampofo, Maxwell; Weiner, Scott G; Douglass, Katherine

2013-12-01

As policy-makers increasingly recognize emergency care to be a global health priority, the need for high-quality clinical and translational research in this area continues to grow. As part of the proceedings of the 2013 Academic Emergency Medicine consensus conference, this article discusses the importance of: 1) including clinical and translational research in the initial emergency care development plan, 2) defining the burden of acute disease and the barriers to conducting research in resource-limited settings, 3) assessing the appropriateness and effectiveness of local and global acute care guidelines within the local context, 4) studying the local research infrastructure needs to understand the best methods to build a sustainable research infrastructure, and 5) studying the long-term effects of clinical research programs on health care systems. © 2013 by the Society for Academic Emergency Medicine.

An Open Letter to the Cancer Community Regarding Community Clinical Trials

Cancer.gov

The National Cancer Institute (NCI) is in the process of combining its two community-based research networks to create a single network that builds on the strengths of the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Prog

Evidence-based practice in speech-language pathology curricula: a scoping study.

PubMed

Togher, Leanne; Yiannoukas, Corina; Lincoln, Michelle; Power, Emma; Munro, Natalie; Mccabe, Patricia; Ghosh, Pratiti; Worrall, Linda; Ward, Elizabeth; Ferguson, Alison; Harrison, Elisabeth; Douglas, Jacinta

2011-12-01

This scoping study investigated how evidence-based practice (EBP) principles are taught in Australian speech-language pathology (SLP) teaching and learning contexts. It explored how Australian SLP university programs: (1) facilitate student learning about the principles of EBP in academic and clinical settings, and (2) self-evaluate their curricula in relation to EBP. The research involved two surveys. Survey 1 respondents were 131 academic staff, program coordinators, and on-campus and off-campus clinical educators. This survey gathered information about EBP teaching and learning in SLP programs as well as future EBP curriculum plans. Survey 2 investigated how clinical educators incorporated EBP into the way they taught clinical decision-making to students. Surveys responses from 85 clinical educators were analysed using descriptive and non-parametric statistics and thematic grouping of open-ended qualitative responses. Both surveys revealed strengths and gaps in integrating EBP into Australian SLP curricula. Perceived strengths were that respondents were positive about EBP, most had EBP training and access to EBP resources. The perceived gaps included the academic staff's perceptions of students' understanding and application of EBP, respondents' understanding of research methodologies, communication and collaboration between academic staff and clinical educators, and a lack of explicit discussion by clinical educators and students of EBP in relation to clients.

Current state of high-risk infant follow-up care in the United States: results of a national survey of academic follow-up programs.

PubMed

Kuppala, V S; Tabangin, M; Haberman, B; Steichen, J; Yolton, K

2012-04-01

High-risk infant follow-up programs have the potential to act as multipurpose clinics by providing continuity of clinical care, education of health care trainees and facilitating outcome data research. Currently there are no nationally representative data on high-risk infant follow-up practices in the United States. The objective of this study is to collect information about the composition of high-risk infant follow-up programs associated with academic centers in the United States, with respect to their structure, function, funding resources and developmental assessment practices, and to identify the barriers to establishment of such programs. Staff neonatologists, follow-up program directors and division directors of 170 Neonatal Intensive Care Units (NICU) associated with pediatric residency programs were invited to participate in an anonymous online survey from October 2009 to January 2010. The overall response rate was 84%. Ninety three percent of the respondents have a follow-up program associated with their NICU. Birth weight, gestational age and critical illness in the NICU were the major criteria for follow-up care. Management of nutrition and neurodevelopmental assessments was the most common service provided. Over 70% have health care trainees in the clinic. About 75% of the respondents have the neurodevelopmental outcome data available. Most of the respondents reported multiple funding sources. Lack of personnel and funding were the most common causes for not having a follow-up program. High-risk infant follow-up programs associated with academic centers in the United States are functioning as multidisciplinary programs providing clinical care, trainee education and facilitating outcomes research.

Implementation of Motivational Interviewing in Substance Use Disorder Treatment: Research Network Participation and Organizational Compatibility.

PubMed

Rieckmann, Traci R; Abraham, Amanda J; Bride, Brian E

Despite considerable empirical evidence that psychosocial interventions improve addiction treatment outcomes across populations, implementation remains problematic. A small body of research points to the importance of research network participation as a facilitator of implementation; however, studies examined limited numbers of evidence-based practices. To address this gap, the present study examined factors impacting implementation of motivational interviewing (MI). This study used data from a national sample of privately funded treatment programs (n = 345) and programs participating in the National Drug Abuse Treatment Clinical Trials Network (CTN) (n = 156). Data were collected via face-to-face interviews with program administrators and clinical directors (2007-2009). Analysis included bivariate t tests and chi-square tests to compare private and CTN programs, and multivariable logistic regression of MI implementation. A majority (68.0%) of treatment programs reported use of MI. Treatment programs participating in the CTN (88.9%) were significantly more likely to report use of MI compared with non-CTN programs (58.5%; P < 0.01). CTN programs (82.1%) also were more likely to use trainers from the Motivational Interviewing Network of Trainers as compared with private programs (56.1%; P < 0.05). Multivariable logistic regression models reveal that CTN-affiliated programs and programs with a psychiatrist on staff were more likely to use MI. Programs that used the Stages of Change Readiness and Treatment Eagerness Scale assessment tool were more likely to use MI, whereas programs placing greater emphasis on confrontational group therapy were less likely to use MI. Findings suggest the critical role of research network participation, access to psychiatrists, and organizational compatibility in adoption and sustained use of MI.

Effect of short-term research training programs on medical students' attitudes toward aging.

PubMed

Jeste, Dilip V; Avanzino, Julie; Depp, Colin A; Gawronska, Maja; Tu, Xin; Sewell, Daniel D; Huege, Steven F

2018-01-01

Strategies to build a larger workforce of physicians dedicated to research on aging are needed. One method to address this shortage of physician scientists in geriatrics is short-term training in aging research for early-stage medical students. The authors examined the effects of two summer research training programs, funded by the National Institutes of Health, on medical students' attitudes toward aging, using the Carolina Opinions on Care of Older Adults (COCOA). The programs combined mentored research, didactics, and some clinical exposure. In a sample of 134 participants, COCOA scores improved significantly after completion of the research training program. There was a significant interaction of gender, such that female students had higher baseline scores than males, but this gender difference in COCOA scores was attenuated following the program. Four of the six COCOA subscales showed significant improvement from baseline: early interest in geriatrics, empathy/compassion, attitudes toward geriatrics careers, and ageism.

Information warehouse - a comprehensive informatics platform for business, clinical, and research applications.

PubMed

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S

2010-11-13

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC's Clinical and Translational Science Award (CTSA) informatics program.

A call for change: clinical evaluation of student registered nurse anesthetists.

PubMed

Collins, Shawn; Callahan, Margaret Faut

2014-02-01

The ability to integrate theory with practice is integral to a student's success. A common reason for attrition from a nurse anesthesia program is clinical issues. To document clinical competence, students are evaluated using various tools. For use of a clinical evaluation tool as possible evidence for a student's dismissal, an important psychometric property to ensure is instrument validity. Clinical evaluation instruments of nurse anesthesia programs are not standardized among programs, which suggests a lack of instrument validity. The lack of established validity of the instruments used to evaluate students' clinical progress brings into question their ability to detect a student who is truly in jeopardy of attrition. Given this possibility, clinical instrument validity warrants research to be fair to students and improve attrition rates based on valid data. This ex post facto study evaluated a 17-item clinical instrument tool to demonstrate the need for validity of clinical evaluation tools. It also compared clinical scores with scores on the National Certification Examination.

A Quality Improvement Initiative to Increase Colorectal Cancer (CRC) Screening: Collaboration between a Primary Care Clinic and Research Team

PubMed Central

Green, Beverly B.; Fuller, Sharon; Anderson, Melissa L.; Mahoney, Christine; Mendy, Peter; Powell, Susan L.

2017-01-01

Background Multiple randomized controlled trials have demonstrated that mailed fecal testing programs are effective in increasing colorectal cancer screening participation. However, few healthcare organization in the US have Implemented such programs. Methods Stakeholders from one clinic in an integrated healthcare system in Washington State initiated collaboration with researchers with expertise in CRC screening, aiming to increase screening rates at their clinic. Age-eligible individuals who were overdue for CRC screening and had previously completed a fecal test were randomized to receive mailed fecal immunochemical test kits (FIT) at the start of the project (Early) or 6 months later (Late). Outcomes included comparing FIT completion at 6 months by randomization group, and overall CRC screening rates at 12 months. We also assessed implementation facilitators and challenges. Results Overall 2,421 FIT tests were mailed at a cost of $10,739. At 6 months, FIT completion was significantly higher among the Early compared to the Late group (62% vs.47%, p <0.001). By 12 months, after both groups had received mailings, 71% in each group had completed a FIT. The clinic’s overall CRC screening rate was 75.1% at baseline and 78.0% 12 months later. Key constructs associated with successful program implementation included strong stakeholder involvement, use of evidence-based strategies, simplicity, and low cost. Challenges included lack of a plan for maintaining the program. Discussion Collaboration between clinic stakeholders and researchers led to a successful project that rapidly increased CRC screening rates. However, institutional normalization of the program would be required to maintain it. PMID:29399669

Intercultural Competency in Public Health: A Call for Action to Incorporate Training into Public Health Education

PubMed Central

Fleckman, Julia M.; Dal Corso, Mark; Ramirez, Shokufeh; Begalieva, Maya; Johnson, Carolyn C.

2015-01-01

Due to increasing national diversity, programs addressing cultural competence have multiplied in U.S. medical training institutions. Although these programs share common goals for improving clinical care for patients and reducing health disparities, there is little standardization across programs. Furthermore, little progress has been made to translate cultural competency training from the clinical setting into the public health setting where the focus is on population-based health, preventative programming, and epidemiological and behavioral research. The need for culturally relevant public health programming and culturally sensitive public health research is more critical than ever. Awareness of differing cultures needs to be included in all processes of planning, implementation and evaluation. By focusing on community-based health program planning and research, cultural competence implies that it is possible for public health professionals to completely know another culture, whereas intercultural competence implies it is a dual-sided process. Public health professionals need a commitment toward intercultural competence and skills that demonstrate flexibility, openness, and self-reflection so that cultural learning is possible. In this article, the authors recommend a number of elements to develop, adapt, and strengthen intercultural competence education in public health educational institutions. PMID:26389109

Intercultural Competency in Public Health: A Call for Action to Incorporate Training into Public Health Education.

PubMed

Fleckman, Julia M; Dal Corso, Mark; Ramirez, Shokufeh; Begalieva, Maya; Johnson, Carolyn C

2015-01-01

Due to increasing national diversity, programs addressing cultural competence have multiplied in U.S. medical training institutions. Although these programs share common goals for improving clinical care for patients and reducing health disparities, there is little standardization across programs. Furthermore, little progress has been made to translate cultural competency training from the clinical setting into the public health setting where the focus is on population-based health, preventative programming, and epidemiological and behavioral research. The need for culturally relevant public health programming and culturally sensitive public health research is more critical than ever. Awareness of differing cultures needs to be included in all processes of planning, implementation and evaluation. By focusing on community-based health program planning and research, cultural competence implies that it is possible for public health professionals to completely know another culture, whereas intercultural competence implies it is a dual-sided process. Public health professionals need a commitment toward intercultural competence and skills that demonstrate flexibility, openness, and self-reflection so that cultural learning is possible. In this article, the authors recommend a number of elements to develop, adapt, and strengthen intercultural competence education in public health educational institutions.

Clinical Data Warehouse: An Effective Tool to Create Intelligence in Disease Management.

PubMed

Karami, Mahtab; Rahimi, Azin; Shahmirzadi, Ali Hosseini

Clinical business intelligence tools such as clinical data warehouse enable health care organizations to objectively assess the disease management programs that affect the quality of patients' life and well-being in public. The purpose of these programs is to reduce disease occurrence, improve patient care, and decrease health care costs. Therefore, applying clinical data warehouse can be effective in generating useful information about aspects of patient care to facilitate budgeting, planning, research, process improvement, external reporting, benchmarking, and trend analysis, as well as to enable the decisions needed to prevent the progression or appearance of the illness aligning with maintaining the health of the population. The aim of this review article is to describe the benefits of clinical data warehouse applications in creating intelligence for disease management programs.

Developmental Programming of Adult Disease: Reprogramming by Melatonin?

PubMed

Tain, You-Lin; Huang, Li-Tung; Hsu, Chien-Ning

2017-02-16

Adult-onset chronic non-communicable diseases (NCDs) can originate from early life through so-called the "developmental origins of health and disease" (DOHaD) or "developmental programming". The DOHaD concept offers the "reprogramming" strategy to shift the treatment from adulthood to early life, before clinical disease is apparent. Melatonin, an endogenous indoleamine produced by the pineal gland, has pleiotropic bioactivities those are beneficial in a variety of human diseases. Emerging evidence support that melatonin is closely inter-related to other proposed mechanisms contributing to the developmental programming of a variety of chronic NCDs. Recent animal studies have begun to unravel the multifunctional roles of melatonin in many experimental models of developmental programming. Even though some progress has been made in research on melatonin as a reprogramming strategy to prevent DOHaD-related NCDs, future human studies should aim at filling the translational gap between animal models and clinical trials. Here, we review several key themes on the reprogramming effects of melatonin in DOHaD research. We have particularly focused on the following areas: mechanisms of developmental programming; the interrelationship between melatonin and mechanisms underlying developmental programming; pathophysiological roles of melatonin in pregnancy and fetal development; and insight provided by animal models to support melatonin as a reprogramming therapy. Rates of NCDs are increasing faster than anticipated all over the world. Hence, there is an urgent need to understand reprogramming mechanisms of melatonin and to translate experimental research into clinical practice for halting a growing list of DOHaD-related NCDs.

Air Force Personalized Medicine Program Panel: Representative Research at the 59th Medical Wing San Antonio Military Medical Center

DTIC Science & Technology

2016-05-18

and treatment strategies at the San Antonio Military Health System. Panel members will describe studies in Disease Management providing evidence for...Application in a Clinical CBA: AFMSand MAJCOM Needs (Research Knowledge) Setti g Optimization of Pharmacologic Cardiovascular Personalized Care...Medicine Research Program Development of Human Mesenchymal Stem Cells for Treatment of Immune System Dysregulation in Neurological & other Diseases

Transporting Clinical Research to Community Settings: Designing and Conducting a Multisite Trial of Brief Strategic Family Therapy

PubMed Central

Robbins, Michael S.; Alonso, Elizabeth; Horigian, Viviana E.; Bachrach, Ken; Burlew, Kathy; Carrión, Ibis S.; Hodgkins, Candace C.; Miller, Michael; Schindler, Eric; VanDeMark, Nancy; Henderson, Craig; Szapocznik, José

2010-01-01

This paper describes the development and implementation of a trial of Brief Strategic Family Therapy (BSFT), an evidence-based drug intervention for adolescents, in eight community substance abuse treatment programs. Researchers and treatment programs collaborated closely to identify and overcome challenges, many of them related to achieving results that were both scientifically rigorous and applicable to the widest possible variety of adolescent substance abuse treatment programs. To meet these challenges, the collaborative team drew on lessons and practices from efficacy, effectiveness, and implementation research. PMID:22002455

fastPACE Train-the-Trainer: A scalable new educational program to accelerate training in biomedical innovation, entrepreneurship, and commercialization.

PubMed

Servoss, Jonathan; Chang, Connie; Fay, Jonathan; Lota, Kanchan Sehgal; Mashour, George A; Ward, Kevin R

2017-10-01

The Institute of Medicine recommended the advance of innovation and entrepreneurship training programs within the Clinical & Translational Science Award (CTSA) program; however, there remains a gap in adoption by CTSA institutes. The University of Michigan's Michigan Institute for Clinical & Health Research and Fast Forward Medical Innovation (FFMI) partnered to develop a pilot program designed to teach CTSA hubs how to implement innovation and entrepreneurship programs at their home institutions. The program provided a 2-day onsite training experience combined with observation of an ongoing course focused on providing biomedical innovation, commercialization and entrepreneurial training to a medical academician audience (FFMI fast PACE). All 9 participating CTSA institutes reported a greater connection to biomedical research commercialization resources. Six launched their own version of the FFMI fast PACE course or modified existing programs. Two reported greater collaboration with their technology transfer offices. The FFMI fast PACE course and training program may be suitable for CTSA hubs looking to enhance innovation and entrepreneurship within their institutions and across their innovation ecosystems.

Clinical and Translational Science Awards: can they increase the efficiency and speed of clinical and translational research?

PubMed

Heller, Caren; de Melo-Martín, Inmaculada

2009-04-01

Most agree that the recent decades-long boom in biomedical research discoveries has not had a sufficient effect on the public's health. To overcome some of the barriers to speeding clinical and translational (C/T) research, the National Institutes of Health has established the Institutional Clinical and Translational Science Award (CTSA). To explore whether the CTSA proposal addresses major C/T barriers and whether funded institutions offer adequate solutions, the authors reviewed the obstacles to C/T research described in the literature and examined the completeness of the solutions offered by the 12 initial CTSA awardees. Through an analysis of the literature, the authors categorized C/T barriers into three categories (research workforce, research operations, and organizational silos). They then analyzed each CTSA proposal regarding the types of programs offered to address these barriers. They found that, in general, institutions developed detailed programs to address research workforce and research operations barriers but had limited to no solutions for organizational silos. The authors suggest that differences in how barriers are addressed are consistent with the degree of control that CTSA centers have over these obstacles and solutions. They argue that although CTSA centers might have an important role in successfully addressing some of the barriers to C/T research, CTSA centers might ultimately have difficulties achieving their purported goal of facilitating and increasing the efficiency and speed of C/T research because of a lack of control over solutions to some important obstacles facing such research.

Physician Assistant/Sr. Nurse Practitioner | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides quality Physician Assistant and/or Nurse Practitioner clinical research services in support of the Urologic Oncology Branch (UOB), National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR). KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Physician Extender: Provides clinical care in collaboration with physicians and health care professionals. Performs a comprehensive physical assessment and documents findings in the appropriate format following institutional and protocol standards. Assesses the patient's general health status through observation and the use of appropriate screening procedures. Acquires patient data through health history taking that includes family history and significant social information. Explains the care management/discharge plan to all members of the covering team (inpatient NPs, attendings) at sign-out. Provides teaching and guidance related to the patient's current state of health and understanding of his/her disease to promote optimal performance. Coordinates study enrollment, collaborates with nursing staff to provide protocol treatment, and provides follow-up care for patients participating in clinical trials. Assists the Principal Investigator (PI) in assuring informed consent forms have been signed, obtaining written consent for treatment, pharmacokinetics, and assessing patients on the study for complications. Calculates the dose of and prescribes chemotherapy, investigational agents, medications, intravenous fluids and blood products according to established protocol, institutional, and practice guidelines. Provides guidance in the management of specific problems for the patient resulting from chemotherapy, immunotherapy or other treatments. Manages appropriate referrals to other specialists as indicated. Screens new patient calls and provides phone triage for active patients. Orders radiological studies, following protocols and patient care guidelines. Orders and interprets lab studies. Attends new patient consultations with the patient and family for the purpose of explaining the diagnosis, protocol, and treatment program, and establishing a rapport. Completes initial and follow-up assessment(s), progress notes and written correspondence to multidisciplinary personnel. Serves as a clinical liaison to area hospices and/or home care agencies as needed or as appropriate. Acts as a clinical liaison between inpatient and outpatient nurses in order to provide continuity of care to the hospitalized patient. Maintains documented evidence of weekly case review with the collaborating physician. Attends and participates in multidisciplinary meetings. Practices within boundaries established by the Nurse Practice Act, State of Maryland and Medical Board of the Clinical Center. Liaises with Leidos Biomed and various NCI staff to initiate and complete tasks relating to medicine and clinical protocols, and all activities related to nursing. Performs clinical data recording and medical chart entries. Dictates admission and discharge summaries. This position is located in Bethesda, Maryland.

Neurogenetics in Child Neurology: Redefining a Discipline in the Twenty-first Century.

PubMed

Kaufmann, Walter E

2016-12-01

Increasing knowledge on genetic etiology of pediatric neurologic disorders is affecting the practice of the specialty. I reviewed here the history of pediatric neurologic disorder classification and the role of genetics in the process. I also discussed the concept of clinical neurogenetics, with its role in clinical practice, education, and research. Finally, I propose a flexible model for clinical neurogenetics in child neurology in the twenty-first century. In combination with disorder-specific clinical programs, clinical neurogenetics can become a home for complex clinical issues, repository of genetic diagnostic advances, educational resource, and research engine in child neurology.

Family medicine research capacity building: five-weekend programs in Ontario.

PubMed

Rosser, Walter; Godwin, Marshall; Seguin, Rachelle

2010-03-01

Research is not perceived as an integral part of family practice by most family physicians working in community practices. OBJECTIVE OF THE PROGRAM To assist community-based practitioners in answering research questions that emerge from their practices in order for them to gain a better understanding of research and its value. The Ontario College of Family Physicians developed a program consisting of 5 sets of weekend workshops, each 2 months apart. Two pilots of the 5-weekend program occurred between 2000 and 2003. After the pilots, thirteen 5-weekend programs were held in 2 waves by 20 facilitators, who were trained in one of two 1-day seminars. This 5-weekend program, developed and tested in Ontario, stimulates community practitioners to learn how to answer research questions emerging from their practices. A 1-day seminar is adequate to train facilitators to successfully run these programs. Evaluations by both facilitators and program participants were very positive, with many participants stating that their clinical practices were improved as a result of the program. The program has been adapted for residency training, and it has already been used internationally.

Cancer Pharmacogenomics: Integrating Discoveries in Basic, Clinical and Population Sciences to Advance Predictive Cancer Care

Cancer.gov

Cancer Pharmacogenomics: Integrating Discoveries in Basic, Clinical and Population Sciences to Advance Predictive Cancer Care, a 2010 workshop sponsored by the Epidemiology and Genomics Research Program.

[Development of clinical trial education program for pharmaceutical science students through small group discussion and role-playing using protocol].

PubMed

Imakyure, Osamu; Shuto, Hideki; Nishikawa, Fumi; Hagiwara, Yoshifuka; Inoue, Sachiko; Koyanagi, Taeko; Hirakawa, Masaaki; Kataoka, Yasufumi

2010-08-01

The acquirement of basic knowledge of clinical trials and professional attitude in their practices is a general instructional objective in the Model Core Curriculum for Pharmaceutical Education. Unfortunately, the previous program of clinical trial education was not effective in the acquirement of a professional attitude in their practices. Then, we developed the new clinical trial education program using protocol through small group discussion (SGD) and roll-playing. Our program consists of 7 steps of practical training. In step 1, the students find some problems after presentation of the protocol including case and prescription. In step 2, they analyse the extracted problems and share the information obtained in SGD. In steps 3 and 5, five clinical case scenarios are presented to the students and they discuss which case is suitable for entry to the clinical trial or which case corresponds to the discontinuance criteria in the present designed protocol. In steps 4 and 6, the roll-playing is performed by teachers and students as doctors and clinical research coordinators (CRC) respectively. Further, we conducted a trial practice based on this program for the students. In the student's self-evaluation into five grades, the average score of the skill acquisition level in each step was 3.8-4.7 grade. Our clinical trial education program could be effective in educating the candidates for CRC or clinical pharmacists.

Crossing the Chasm: Information Technology to Biomedical Informatics

PubMed Central

Fahy, Brenda G.; Balke, C. William; Umberger, Gloria H.; Talbert, Jeffery; Canales, Denise Niles; Steltenkamp, Carol L.; Conigliaro, Joseph

2011-01-01

Accelerating the translation of new scientific discoveries to improve human health and disease management is the overall goal of a series of initiatives integrated in the National Institutes of Health (NIH) “Roadmap for Medical Research.” The Clinical and Translational Research Award (CTSA) program is, arguably, the most visible component of the NIH Roadmap providing resources to institutions to transform their clinical and translational research enterprises along the goals of the Roadmap. The CTSA program emphasizes biomedical informatics as a critical component for the accomplishment of the NIH’s translational objectives. To be optimally effective, emerging biomedical informatics programs must link with the information technology (IT) platforms of the enterprise clinical operations within academic health centers. This report details one academic health center’s transdisciplinary initiative to create an integrated academic discipline of biomedical informatics through the development of its infrastructure for clinical and translational science infrastructure and response to the CTSA mechanism. This approach required a detailed informatics strategy to accomplish these goals. This transdisciplinary initiative was the impetus for creation of a specialized biomedical informatics core, the Center for Biomedical Informatics (CBI). Development of the CBI codified the need to incorporate medical informatics including quality and safety informatics and enterprise clinical information systems within the CBI. This paper describes the steps taken to develop the biomedical informatics infrastructure, its integration with clinical systems at one academic health center, successes achieved, and barriers encountered during these efforts. PMID:21383632

Establishment of an effective acute stroke telemedicine program for Australia: protocol for the Victorian Stroke Telemedicine project.

PubMed

Cadilhac, Dominique A; Moloczij, Natasha; Denisenko, Sonia; Dewey, Helen; Disler, Peter; Winzar, Bruce; Mosley, Ian; Donnan, Geoffrey A; Bladin, Christopher

2014-02-01

Urgent treatment of acute stroke in rural Australia is problematic partly because of limited access to medical specialists. Utilization of telemedicine could improve delivery of acute stroke treatments in rural communities. The study aims to demonstrate enhanced clinical decision making for use of thrombolysis within 4·5 h of ischemic stroke symptom onset in a rural setting using a telemedicine specialist support model. A formative program evaluation research design was used. The Victorian Stroke Telemedicine program was developed and will be evaluated over five stages to ensure successful implementation. The phases include: (a) preimplementation phase to establish the Victorian Stroke Telemedicine program including the clinical pathway, data collection tools, and technology processes; (b) pilot clinical application phase to test the pathway in up to 10 patients; (c) modification phase to refine the program; (d) full clinical implementation phase where the program is maintained for one-year; and (e) a sustainability phase to assess project outcomes over five-years. Qualitative (clinician interviews) and quantitative data (patient, clinician, costs, and technology processes) are collected in each phase. The primary outcome is to achieve a minimum 10% absolute increase in eligible patients treated with thrombolysis. Secondary outcomes are utilization of the telestroke pathway and improvements in processes of stroke care (e.g., time to brain scan). We will report door to telemedicine consultation time, length of telemedicine consultation, clinical utility and acceptability from the perspective of clinicians, and 90-day patient outcomes. This research will provide evidence for an effective telestroke program for use in regional Australian hospitals. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

DNA Vaccination Against Metastatic Breast Cancer

DTIC Science & Technology

2001-07-01

cells. Although DNA vaccines have shown effectiveness in clinical trials , it is essential to demonstrate pre- clinical effectiveness for anti-tumor... clinical trials for infectious diseases (4), it is essential to (5-7)demonstrate pre- clinical effectiveness for anti-tumor vaccines before clinical testing...Program Clinical Translational Research (CTR) award to perform a Phase I clinical trial of ELVIS2-neu. Our preliminary application was selected for

NIDA’s Clinical Trials Network: An Opportunity for HIV Research in Community Substance Abuse Treatment Programs

PubMed Central

Tross, Susan; Campbell, Aimee N. C.; Calsyn, Donald A.; Metsch, Lisa R.; Sorensen, James L.; Shoptaw, Steven; Haynes, Louise; Woody, George E.; Malow, Robert M.; Brown, Lawrence S.; Feaster, Daniel J.; Booth, Robert E.; Mandler, Raul N.; Masson, Carmen; Holmes, Beverly W.; Colfax, Grant; Brooks, Audrey J.; Hien, Denise A.; Schackman, Bruce R.; Korthuis, P. Todd; Miele, Gloria M.

2012-01-01

Background/Objectives HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years. Results While emphasizing CTN HIV protocols, this article reviews the (1) HIV context for this work; (2) the collaborative process among providers, researchers, and National Institute on Drug Abuse CTN staff, on which CTN HIV work was based; (3) results of CTN HIV protocols and HIV secondary analyses in CTN non-HIV protocols; and (4) implications for future HIV intervention effectiveness research in community substance abuse treatment programs. Conclusion/Significance While the feasibility of engaging frontline providers in this research is highlighted, the limitations of small to medium effect sizes and weak adoption and sustainability in everyday practice are also discussed. PMID:21854270

NIDA's Clinical Trials Network: an opportunity for HIV research in community substance abuse treatment programs.

PubMed

Tross, Susan; Campbell, Aimee N C; Calsyn, Donald A; Metsch, Lisa R; Sorensen, James L; Shoptaw, Steven; Haynes, Louise; Woody, George E; Malow, Robert M; Brown, Lawrence S; Feaster, Daniel J; Booth, Robert E; Mandler, Raul N; Masson, Carmen; Holmes, Beverly W; Colfax, Grant; Brooks, Audrey J; Hien, Denise A; Schackman, Bruce R; Korthuis, P Todd; Miele, Gloria M

2011-09-01

HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years. While emphasizing CTN HIV protocols, this article reviews the (1) HIV context for this work; (2) the collaborative process among providers, researchers, and National Institute on Drug Abuse CTN staff, on which CTN HIV work was based; (3) results of CTN HIV protocols and HIV secondary analyses in CTN non-HIV protocols; and (4) implications for future HIV intervention effectiveness research in community substance abuse treatment programs. While the feasibility of engaging frontline providers in this research is highlighted, the limitations of small to medium effect sizes and weak adoption and sustainability in everyday practice are also discussed.

Psychiatry chief resident opinions toward basic and clinical neuroscience training and practice.

PubMed

Bennett, Jeffrey I; Handa, Kamna; Mahajan, Aman; Deotale, Pravesh

2014-04-01

The authors queried attendees to a chief resident conference on whether program education and training in neuroscience or in translating neuroscience research into practice is sufficient and what changes are needed. The authors developed and administered a 26-item voluntary questionnaire to each attendee at the Chief Residents' Leadership Conference at the American Psychiatric Association 2013 annual meeting in San Francisco, CA. Out of 94 attendees, 55 completed and returned questionnaires (58.5%). A majority of respondents stated that their program provided adequate training in neuroscience (61.8%); opportunities for neuroscience research existed for them (78.2%), but that their program did not prepare them for translating future neuroscience research findings into clinical practice (78.9%) or educate them on the NIMH Research Domain Criteria (83.3%). A majority of respondents stated that the ACGME should require a specific neuroscience curriculum (79.6%). Chief residents believe that curricular and cultural change is needed in psychiatry residency neuroscience education.

New Funding Opportunity: Tissue Purchase Order Acquisitions | Office of Cancer Clinical Proteomics Research

Cancer.gov

The National Cancer Institute (NCI) is expanding its basic and translational research programs that rely heavily on sufficient availability of high quality, well annotated biospecimens suitable for use in genomic and proteomic studies.  The NCI’s overarching goal with such programs is to improve the ability to diagnose, treat, and prevent cancer.

78 FR 48437 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-08

...: Application for waiver of the two year foreign residence requirement of the Exchange Visitor Program. OMB No.: 0990-0001 Abstract: The HHS program deals with both research and clinical care waivers. Applicant institutions apply to this Department to request a waiver on behalf of research scientists or foreign medical...

Translating an Evidence-Based Behavioral Intervention for Women Living with HIV into Clinical Practice: The SMART/EST Women's Program.

PubMed

Weiss, Stephen M; Tobin, Jonathan N; Lopez, Maria; Simons, Hannah; Cook, Ryan; Jones, Deborah L

2015-06-01

The process of translating scientific findings into clinical and public health settings has only recently received priority attention within the scientific community. Fueled by "Funding Opportunity Announcements" from the National Institutes of Health and Centers for Disease Control and Prevention, scientists have begun to explore the pathways to effectively "transfer" promising research accomplishments into effective and sustainable service programs within the health care delivery system. Using Glasgow's RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) model as a guide, this research team enrolled 428 socially disadvantaged, culturally diverse women living with HIV/AIDS to test the dissemination and implementation of an evidence-based behavioral intervention designed to improve and sustain the physical and emotional health of participants into the Community Health Center (CHC) setting when conducted by trained CHC staff. Findings demonstrate the ability of trained CHC staff group leaders to attain results equivalent or superior to those achieved when conducted by research staff on the three principal study outcomes: depression, medication adherence and HIV viral load. Four of five CHCs involved in the study also identified and successfully obtained funding to continue to run intervention groups, supporting the adoption and sustainability components of the translation model. This study confirmed (a) the "translatability" of the Stress Management And Relaxation Training/Emotional Supportive Therapy (SMART/EST) Women's Program, from academic to CHC settings in two geographic regions with high HIV prevalence among women, (b) the ability of local staff (using the "train the trainer" model) to successfully achieve program fidelity and clinical outcomes, and (c) the sustainability the program beyond the auspices of research support, through supportive CHC leadership securing continued program funding.

[Training of institutional research networks as a strategy of improvement].

PubMed

Galván-Plata, María Eugenia; Almeida-Gutiérrez, Eduardo; Salamanca-Gómez, Fabio Abdel

2017-01-01

The Instituto Mexicano del Seguro Social (IMSS) through the Coordinación de Investigación en Salud (Health Research Council) has promoted a strong link between the generation of scientific knowledge and the clinical care through the program Redes Institucionales de Investigación (Institutional Research Network Program), whose main aim is to promote and generate collaborative research between clinical, basic, epidemiologic, educational, economic and health services researchers, seeking direct benefits for patients, as well as to generate a positive impact on institutional processes. All of these research lines have focused on high-priority health issues in Mexico. The IMSS internal structure, as well as the sufficient health services coverage, allows the integration of researchers at the three levels of health care into these networks. A few years after their creation, these networks have already generated significant results, and these are currently applied in the institutional regulations in diseases that represent a high burden to health care. Two examples are the National Health Care Program for Patients with Acute Myocardial Infarction "Código Infarto", and the Early Detection Program on Chronic Kidney Disease; another result is the generation of multiple scientific publications, and the promotion of training of human resources in research from the same members of our Research Networks. There is no doubt that the Coordinación de Investigación en Salud advances steadily implementing the translational research, which will keep being fruitful to the benefit of our patients, and of our own institution.

Implementation and Effectiveness of a Mailed FIT Outreach Program in Safety Net Clinics

Cancer.gov

Gloria Coronado, PhD, is an epidemiologist and the Mitch Greenlick Endowed Senior Investigator in Health Disparities Research at Kaiser Permanente Center for Health Research in Portland, OR. Her research focuses on understanding and addressing disparities in the occurrence and burden of disease in underserved populations, with a special emphasis on testing cancer prevention intervention in underserved and Medicaid-enrolled populations. She has developed several innovative and cost-effective interventions to improve rates of participation in cancer screening among patients served by community health centers. Her work has led to partnerships with large health plans, state institutions, and clinics who serve migrants and the uninsured. Dr. Coronado received her PhD in epidemiology from the University of Washington and became a research associate professor in the university’s Department of Epidemiology, in addition to receiving training at Stanford. She currently directs or co-directs three programs that use systems-based approaches to raise the rates of colorectal cancer screening in health plans and clinics in Washington, Oregon and California.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

PubMed

Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A; Martin, Michelle Y; Durant, Raegan W; Ford, Jean G

2014-04-01

Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. © 2014 American Cancer Society.

State-of-the-Science of Patient Navigation as a Strategy for Enhancing Minority Clinical Trial Accrual

PubMed Central

Ghebre, Rahel G.; Jones, Lovell A.; Wenzel, Jennifer; Martin, Michelle Y.; Durant, Raegan; Ford, Jean G.

2014-01-01

Background Patient navigation programs are emerging, that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process, as well as outcome measures to evaluate program effectiveness. Methods A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. Results The eligible studies reported on development of programs for patient navigation in cancer clinical trials, including training and implementation among African American, American Indian and Native Hawaiians. Low clinical trial refusal, 4% to 6%, was reported among patients enrolled in patient navigation program. However, few studies reported on the efficacy of patient navigation on increasing clinical treatment trial enrollment. Conclusion Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients. PMID:24643650

Evidence-based use of electronic clinical tracking systems in advanced practice registered nurse education: an integrative review.

PubMed

Branstetter, M Laurie; Smith, Lynette S; Brooks, Andrea F

2014-07-01

Over the past decade, the federal government has mandated healthcare providers to incorporate electronic health records into practice by 2015. This technological update in healthcare documentation has generated a need for advanced practice RN programs to incorporate information technology into education. The National Organization of Nurse Practitioner Faculties created core competencies to guide program standards for advanced practice RN education. One core competency is Technology and Information Literacy. Educational programs are moving toward the utilization of electronic clinical tracking systems to capture students' clinical encounter data. The purpose of this integrative review was to evaluate current research on advanced practice RN students' documentation of clinical encounters utilizing electronic clinical tracking systems to meet advanced practice RN curriculum outcome goals in information technology as defined by the National Organization of Nurse Practitioner Faculties. The state of the science depicts student' and faculty attitudes, preferences, opinions, and data collections of students' clinical encounters. Although electronic clinical tracking systems were utilized to track students' clinical encounters, these systems have not been evaluated for meeting information technology core competency standards. Educational programs are utilizing electronic clinical tracking systems with limited evidence-based literature evaluating the ability of these systems to meet the core competencies in advanced practice RN programs.

Brokering the Evidence-Practice Gap: A Strategy for Moving Evidence Into Clinical Practice.

PubMed

Segre, Lisa S; Trusty, Stephanie; Gullickson, Renee; Chuffo Davila, Rebecca; O'Hara, Michael W

2018-05-08

Moving novel, evidence-based interventions into broad community use is challenging. This column describes how a midlevel public health administrator acted in the role of broker to link university-based researchers with maternal health clinical staff to successfully implement an innovative, evidence-based maternal depression treatment. Program evaluation assessed adoption, implementation, reach, and effectiveness. In reflecting on this partnership, the broker provided critical elements of access, credibility, and accountability. A partnership between service providers and research teams provides one strategy to disseminate evidence-based practices among those served by public-health programs.

Forced Migration as Public Relations Process? Lothar B. Kalinowsky and the Trans-Atlantic Transfer of Electroconvulsive Therapy.

PubMed

Stahnisch, Frank W

2016-01-01

Research in biological psychiatry during the first half of the 20 th century was based upon a wide range of interrelated disciplines, including neurology, neuroanatomy, neuropathology, and experimental biology. The work of German-American psychiatrist and neurologist Lothar B. Kalinowsky (1899-1992) is taken here as an example of how such fields could be combined to produce a highly innovative and multidimensional research program in clinical neuroscience. Kalinowsky functioned exceptionally well in both scientific and clinical cultures despite the marked contextual differences between the Charité in Berlin and his later workplace in New York's Columbia Medical School. The innovative ideas exemplified by Kalinowsky's efforts, however, sometimes amounted to a dubious advantage for émigré clinical neuroscientists: they easily led to incommensurable scientific views, and sometimes even resulted in the marginalization of the innovator from existing research programs.

Collaboration: integrating practice and research in public health nursing.

PubMed

Henry, V; Schmitz, K; Reif, L; Rudie, P

1992-12-01

The need to integrate clinical practice and research has been stressed for many years in both public health and nursing. This article describes such a collaborative project between two rural upper Midwest public health nursing agencies and public health nursing faculty from a small, liberal arts, baccalaureate nursing program. The high-risk prenatal research project provided an opportunity for nursing staff and faculty research consultants to work together on a clinical study. A model for collaborative research is illustrated, and advantages and disadvantages for practice, administration, and research are discussed.

NCORP’s First Year Reviewed | Division of Cancer Prevention

Cancer.gov

By the numbers, the first year of NCI’s Community Oncology Research Program (NCORP) has made progress in clinical trials for prevention, control, health-related quality of life, comparative effectiveness and screening; accrual to NCI National Clinical Trials Network treatment and imaging trials; and in new areas of emphasis in cancer care delivery research and cancer

77 FR 65567 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... for Scientific Review Special Emphasis Panel; PA-12-139: Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition. Date: November 29, 2012. Time: 2:00 p.m. to 4:00 p.m. Agenda... Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93...

The UNAM M. Sc. program in Medical Physics enters its teen years

NASA Astrophysics Data System (ADS)

Brandan, María-Ester

2010-12-01

The M.Sc. (Medical Physics) program at the National Autonomous University of Mexico UNAM, created in 1997, has graduated a substantial number of medical physicists who constitute today about 30% of the medical physics clinical workforce in the country. Up to present date (May 2010) more than 60 students have graduated, 60% of them hold clinical jobs, 20% have completed or study a Ph.D., and 15% perform activities related to this specialization. In addition to strengthening the clinical practice of medical physics, the program has served as an incentive for medical physics research in UNAM and other centers. We report the circumstances of the program origin, the evolution of its curriculum, the main achievements, and the next challenges.

Building capacity for knowledge translation in occupational therapy: learning through participatory action research.

PubMed

Bennett, Sally; Whitehead, Mary; Eames, Sally; Fleming, Jennifer; Low, Shanling; Caldwell, Elizabeth

2016-10-01

There has been widespread acknowledgement of the need to build capacity in knowledge translation however much of the existing work focuses on building capacity amongst researchers rather than with clinicians directly. This paper's aim is to describe a research project for developing a knowledge translation capacity building program for occupational therapy clinicians. Participatory action research methods were used to both develop and evaluate the knowledge translation capacity-building program. Participants were occupational therapists from a large metropolitan hospital in Australia. Researchers and clinicians worked together to use the action cycle of the Knowledge to Action Framework to increase use of knowledge translation itself within the department in general, within their clinical teams, and to facilitate knowledge translation becoming part of the department's culture. Barriers and enablers to using knowledge translation were identified through a survey based on the Theoretical Domains Framework and through focus groups. Multiple interventions were used to develop a knowledge translation capacity-building program. Fifty-two occupational therapists participated initially, but only 20 across the first 18 months of the project. Barriers and enablers were identified across all domains of the Theoretical Domains Framework. Interventions selected to address these barriers or facilitate enablers were categorised into ten different categories: educational outreach; teams working on clinical knowledge translation case studies; identifying time blocks for knowledge translation; mentoring; leadership strategies; communication strategies; documentation and resources to support knowledge translation; funding a knowledge translation champion one day per week; setting goals for knowledge translation; and knowledge translation reporting strategies. Use of these strategies was, and continues to be monitored. Participants continue to be actively involved in learning and shaping the knowledge translation program across the department and within their specific clinical areas. To build capacity for knowledge translation, it is important to involve clinicians. The action cycle of the Knowledge to Action framework is a useful guide to introduce the knowledge translation process to clinicians. It may be used to engage the department as a whole, and facilitate the learning and application of knowledge translation within specific clinical areas. Research evaluating this knowledge translation program is being conducted.

Psychology of the scientist: LXXXI. Professional school and traditional program graduates: comparison on measures of achievement in clinical psychology.

PubMed

Templer, D I; Tomeo, M E; Pointkowski, S R; Mitroff, D; Niederhauser, R N; Siscoe, K

2000-06-01

Clinical psychologists who graduated from traditional programs and those who graduated from professional schools were compared on both scientifically and professionally oriented criteria of achievement and recognition. Upon controlling for year of graduation from a doctoral program, the professional school graduates were less likely to be APA fellows, less likely to be on the editorial board of specified research oriented journals in clinical psychology, less likely to have diplomate status in the American Board of Professional Psychology (ABPP), less likely to have been president of state psychological associations, and less likely to have been APPIC internship directors.

Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI-Cardiovascular Medical Research and Education Fund Workshop Report.

PubMed

Newman, John H; Rich, Stuart; Abman, Steven H; Alexander, John H; Barnard, John; Beck, Gerald J; Benza, Raymond L; Bull, Todd M; Chan, Stephen Y; Chun, Hyung J; Doogan, Declan; Dupuis, Jocelyn; Erzurum, Serpil C; Frantz, Robert P; Geraci, Mark; Gillies, Hunter; Gladwin, Mark; Gray, Michael P; Hemnes, Anna R; Herbst, Roy S; Hernandez, Adrian F; Hill, Nicholas S; Horn, Evelyn M; Hunter, Kendall; Jing, Zhi-Cheng; Johns, Roger; Kaul, Sanjay; Kawut, Steven M; Lahm, Tim; Leopold, Jane A; Lewis, Greg D; Mathai, Stephen C; McLaughlin, Vallerie V; Michelakis, Evangelos D; Nathan, Steven D; Nichols, William; Page, Grier; Rabinovitch, Marlene; Rich, Jonathan; Rischard, Franz; Rounds, Sharon; Shah, Sanjiv J; Tapson, Victor F; Lowy, Naomi; Stockbridge, Norman; Weinmann, Gail; Xiao, Lei

2017-06-15

The Division of Lung Diseases of the NHLBI and the Cardiovascular Medical Education and Research Fund held a workshop to discuss how to leverage the anticipated scientific output from the recently launched "Redefining Pulmonary Hypertension through Pulmonary Vascular Disease Phenomics" (PVDOMICS) program to develop newer approaches to pulmonary vascular disease. PVDOMICS is a collaborative, protocol-driven network to analyze all patient populations with pulmonary hypertension to define novel pulmonary vascular disease (PVD) phenotypes. Stakeholders, including basic, translational, and clinical investigators; clinicians; patient advocacy organizations; regulatory agencies; and pharmaceutical industry experts, joined to discuss the application of precision medicine to PVD clinical trials. Recommendations were generated for discussion of research priorities in line with NHLBI Strategic Vision Goals that include: (1) A national effort, involving all the stakeholders, should seek to coordinate biosamples and biodata from all funded programs to a web-based repository so that information can be shared and correlated with other research projects. Example programs sponsored by NHLBI include PVDOMICS, Pulmonary Hypertension Breakthrough Initiative, the National Biological Sample and Data Repository for PAH, and the National Precision Medicine Initiative. (2) A task force to develop a master clinical trials protocol for PVD to apply precision medicine principles to future clinical trials. Specific features include: (a) adoption of smaller clinical trials that incorporate biomarker-guided enrichment strategies, using adaptive and innovative statistical designs; and (b) development of newer endpoints that reflect well-defined and clinically meaningful changes. (3) Development of updated and systematic variables in imaging, hemodynamic, cellular, genomic, and metabolic tests that will help precisely identify individual and shared features of PVD and serve as the basis of novel phenotypes for therapeutic interventions.

Evaluation of otolaryngology residency program websites.

PubMed

Svider, Peter F; Gupta, Amar; Johnson, Andrew P; Zuliani, Giancarlo; Shkoukani, Mahdi A; Eloy, Jean Anderson; Folbe, Adam J

2014-10-01

Prior to applying or interviewing, most prospective applicants turn to the Internet when evaluating residency programs, making maintenance of a comprehensive website critical. While certain "intangibles" such as reputation may not be communicated effectively online, residency websites are invaluable for conveying other aspects of a program. Prior analyses have reported that certain criteria such as research experience and didactics are important considerations for applicants. To evaluate the comprehensiveness of otolaryngology residency websites. Review of otolaryngology residency program websites. Websites of 99 civilian residency programs were searched for the presence of 23 criteria. Presence of 23 criteria for application process, incentives, instruction, research, clinical training, and other. Only 5 programs contained at least three-quarters of the criteria analyzed; on average programs reported less than 50% of information sought. Among the 99 residency program websites, a description of the following criteria was noted: comprehensive faculty listing (88%), didactics (80%), contact e-mail (77%), current residents (74%), description of facilities (70%), intern schedule (70%), research requirements (69%), otolaryngology rotation schedule (64%), other courses (61%), ERAS (Electronic Residency Application Service) link (55%), year-to-year responsibility progression (47%), call schedule (40%), active/past research projects (37%), area information (34%), message from the program director (33%) or chair (23%), selection criteria (30%), salary (directly on site) (23%), surgical statistics (18%), parking (9%), and meal allowance (7%). The mean (SD) percentage present of factors encompassing "clinical training" was 55% (23%), significantly higher than the mean (SD) percentage of factors covered under the "incentives" category (19% [11%]; P = .01). The proportion of overall criteria present on websites did not differ on organizing programs by region (range, 42%-49%). Sites for "large" programs (≥3 residents per year) were more comprehensive (49% vs 42%; P = .04). While further survey of prospective applicants would be invaluable in determining which factors are of greatest interest, many residency websites appear to be inadequately comprehensive. Despite the relative comprehensiveness of criteria relevant to clinical training when compared with other aspects of websites such as incentives, several crucial aspects of training are still not addressed in many sites.

WE-G-BRB-02: The Role of Program Project Grants in Study of 3D Conformal Therapy, Dose Escalation and Motion Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fraass, B.

2015-06-15

Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

Bone Allografts: What Is the Risk of Disease Transmission with Bone Allografts?

MedlinePlus

... and School-Linked Dental Sealant Programs Coordinate Community Water Fluoridation Programs Targeted Clinical Preventive Services & Health Systems Changes State Oral Health Plans Research & Publications Oral Health In America: Summary of the ...

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

The impact of research education on student nurse attitude, skill and uptake of evidence-based practice: a descriptive longitudinal survey.

PubMed

Leach, Matthew J; Hofmeyer, Anne; Bobridge, Amanda

2016-01-01

To measure the impact of an undergraduate research education program on the attitude, skill and uptake of evidence-based practice among undergraduate student nurses. The contribution of evidence-based practice to clinical decision-making, quality of care and patient outcomes is well-documented. One approach to improving evidence-based practice uptake in clinical practice is through the provision of undergraduate research education; notwithstanding, the impact of research training on nursing practice is poorly established. Descriptive longitudinal survey. Three hundred and fifty four third-year nursing students enrolled in a Bachelor of Nursing program of a large Australian University were invited. Pre- (Phase 1) and post-completion (Phase 2) of a 16-week research education program, participants were asked to complete the Evidence-Based Practice Attitude and Utilization Survey; an 82-item online questionnaire measuring attitudes, skills and use of evidence-based practice, and barriers and facilitators of evidence-based practice uptake. The survey was completed by 84 (24%) participants in Phase 1 and 33 (39% of Phase 1) participants in Phase 2. Program exposure resulted in a significant improvement in median skill and use subscores, but not median attitude subscore. Participants perceived inadequate skills in the interpretation, appraisal and application of research findings to clinical practice as being less of a barrier to evidence-based practice uptake posteducation, and access to online critical appraisal tools as being significantly more useful in facilitating evidence-based practice uptake posteducation. The findings suggest that undergraduate research education may have a significant effect on nursing students' research skills and use of evidence-based practice, and minimise barriers to evidence-based practice uptake posteducation. Undergraduate research education may play an important role in improving student nurse uptake of evidence-based practice; whether these changes can be sustained when transitioning from student nurse to registered nurse is a question for further research. © 2015 John Wiley & Sons Ltd.

77 FR 13133 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... Infectious Diseases Special Emphasis Panel Integrated Preclinical/Clinical Program for HIV Topical..., and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National...

78 FR 40756 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... Infectious Diseases Special Emphasis Panel; Integrated Preclinical/Clinical AIDS Vaccine Development Program..., and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National...

An assessment of time involved in pre-test case review and counseling for a whole genome sequencing clinical research program.

PubMed

Williams, Janet L; Faucett, W Andrew; Smith-Packard, Bethanny; Wagner, Monisa; Williams, Marc S

2014-08-01

Whole genome sequencing (WGS) is being used for evaluation of individuals with undiagnosed disease of suspected genetic origin. Implementing WGS into clinical practice will place an increased burden upon care teams with regard to pre-test patient education and counseling about results. To quantitate the time needed for appropriate pre-test evaluation of participants in WGS testing, we documented the time spent by our clinical research group on various activities related to program preparation, participant screening, and consent prior to WGS. Participants were children or young adults with autism, intellectual or developmental disability, and/or congenital anomalies, who have remained undiagnosed despite previous evaluation, and their biologic parents. Results showed that significant time was spent in securing allocation of clinical research space to counsel participants and families, and in acquisition and review of participant's medical records. Pre-enrollment chart review identified two individuals with existing diagnoses resulting in savings of $30,000 for the genome sequencing alone, as well as saving hours of personnel time for genome interpretation and communication of WGS results. New WGS programs should plan for costs associated with additional pre-test administrative planning and patient evaluation time that will be required to provide high quality care.

Increasing participation in prevention research: strategies for youths, parents, and schools.

PubMed

Hooven, Carole; Walsh, Elaine; Willgerodt, Mayumi; Salazar, Amy

2011-08-01

Subject participation is a critical concern for clinicians and researchers involved in prevention programs, especially for intensive interventions that require randomized assignment and lengthy youth and parent involvement. This article describes details of an integrated approach used to recruit and retain at-risk high school youths, their parents, and high schools to two different comprehensive, "indicated" prevention programs. Parent and youth recruitment and retention data for the two studies is provided in support of the approach described. A coordinated, multilevel approach, organized around cross-cutting issues, is described in detail as a response to the challenges of including vulnerable populations in intervention research. Methods are relevant to nurse clinicians who deliver prevention programs, and are important to clinical research that relies upon adequate participation in research programs. © 2011 Wiley Periodicals, Inc.

Developmental Scientist | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Developmental Scientist will: Provide support and advisement to the development of the T Cell receptor gene therapy protocols. Establishes, implements and maintains standardized processes and assesses performance to make recommendations for improvement. Provides support and guidance to the cellular therapy or vector production facilities at the NIH Clinical Center engaged in the manufacture of patient-specific therapies. Manufactures cellular therapy products for human use. Develops and manufactures lentiviral and/or retroviral vectors. Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance. Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines. Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer. Serves as a leader/mentor to administrative staff and prepares employee performance evaluations. Develops and implements procedures/programs to ensure effective and efficient business and operational processes. Identifies potential bottlenecks in upcoming development processes and works with team members and senior management for resolution. Analyzes and tracks initiatives and contracts. Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, laboratory and office supplies to ensure compliance with appropriate government regulations. Coordinates the administrative, fiscal, contractual, and quality aspects of all projects. Ensures that internal budgets, schedules and performance requirements are met. Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available. Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted. Regularly interacts with senior or executive management both internally and externally, on matters concerning several functional areas such as operations, quality control and quality assurance. Participates in planning facility or operations modifications, upgrades and renovations. Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control. Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads and evaluating overall performance. This position is located in Bethesda, Maryland.

Clinical Reasoning: Survey of Teaching Methods, Integration, and Assessment in Entry-Level Physical Therapist Academic Education.

PubMed

Christensen, Nicole; Black, Lisa; Furze, Jennifer; Huhn, Karen; Vendrely, Ann; Wainwright, Susan

2017-02-01

Although clinical reasoning abilities are important learning outcomes of physical therapist entry-level education, best practice standards have not been established to guide clinical reasoning curricular design and learning assessment. This research explored how clinical reasoning is currently defined, taught, and assessed in physical therapist entry-level education programs. A descriptive, cross-sectional survey was administered to physical therapist program representatives. An electronic 24-question survey was distributed to the directors of 207 programs accredited by the Commission on Accreditation in Physical Therapy Education. Descriptive statistical analysis and qualitative content analysis were performed. Post hoc demographic and wave analyses revealed no evidence of nonresponse bias. A response rate of 46.4% (n=96) was achieved. All respondents reported that their programs incorporated clinical reasoning into their curricula. Only 25% of respondents reported a common definition of clinical reasoning in their programs. Most respondents (90.6%) reported that clinical reasoning was explicit in their curricula, and 94.8% indicated that multiple methods of curricular integration were used. Instructor-designed materials were most commonly used to teach clinical reasoning (83.3%). Assessment of clinical reasoning included practical examinations (99%), clinical coursework (94.8%), written examinations (87.5%), and written assignments (83.3%). Curricular integration of clinical reasoning-related self-reflection skills was reported by 91%. A large number of incomplete surveys affected the response rate, and the program directors to whom the survey was sent may not have consulted the faculty members who were most knowledgeable about clinical reasoning in their curricula. The survey construction limited some responses and application of the results. Although clinical reasoning was explicitly integrated into program curricula, it was not consistently defined, taught, or assessed within or between the programs surveyed-resulting in significant variability in clinical reasoning education. These findings support the need for the development of best educational practices for clinical reasoning curricula and learning assessment. © 2017 American Physical Therapy Association

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

78 FR 78984 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant (R34) and Clinical Trial... Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and...

Clinical peer review program self-evaluation for US hospitals.

PubMed

Edwards, Marc T

2010-01-01

Prior research has shown wide variation in clinical peer review program structure, process, governance, and perceived effectiveness. This study sought to validate the utility of a Peer Review Program Self-Evaluation Tool as a potential guide to physician and hospital leaders seeking greater program value. Data from 330 hospitals show that the total score from the self-evaluation tool is strongly associated with perceived quality impact. Organizational culture also plays a significant role. When controlling for these factors, there was no evidence of benefit from a multispecialty review process. Physicians do not generally use reliable methods to measure clinical performance. A high rate of change since 2007 has not produced much improvement. The Peer Review Program Self-Evaluation Tool reliably differentiates hospitals along a continuum of perceived program performance. The full potential of peer review as a process to improve the quality and safety of care has yet to be realized.

Clinical research in a hospital--from the lone rider to teamwork.

PubMed

Hannisdal, E

1996-01-01

Clinical research of high international standard is very demanding and requires clinical data of high quality, software, hardware and competence in research design and statistical treatment of data. Most busy clinicians have little time allocated for clinical research and this increases the need for a potent infrastructure. This paper describes how the Norwegian Radium Hospital, a specialized cancer hospital, has reorganized the clinical research process. This includes a new department, the Clinical Research Office, which serves the formal framework, a central Diagnosis Registry, clinical databases and multicentre studies. The department assists about 120 users, mainly clinicians. Installation of a network software package with over 10 programs has strongly provided an internal standardization, reduced the costs and saved clinicians a great deal of time. The hospital is building up about 40 diagnosis-specific clinical databases with up to 200 variables registered. These databases are shared by the treatment group and seem to be important tools for quality assurance. We conclude that the clinical research process benefits from a firm infrastructure facilitating teamwork through extensive use of modern information technology. We are now ready for the next phase, which is to work for a better external technical framework for cooperation with other institutions throughout the world.

Methods of Academic Course Planning for Cancer Biology PhD Students to Enhance Knowledge of Clinical Oncology.

PubMed

Mattes, Malcolm D; Swart, Elizabeth; Markwell, Steven M; Wen, Sijin; Vona-Davis, Linda C

2017-09-15

Little is known about how clinical oncology concepts are taught to PhD students or the most effective methods of doing so. In this study, electronic surveys were sent to faculty and students at PhD training programs, assessing their institution's methods of clinical oncology education and their perspective on optimal approaches to clinical oncology education. Only 40.0% of students reported any clinical oncology component to their institution's training, and only 26.5% had a clinician on their graduate advisory committee. Forty-three percent of students believed that they had a good understanding for translating basic science research into clinical practice, and 77.2% of all participants believed dual degree MD/PhD students were superior to PhD students in this regard. Lectures on clinical oncology research topics were the most valuable type of experience for all participants and were also the most common type of experience utilized. Working with a clinician to develop a clinical trial with correlative endpoints was also highly valued, but was only utilized by approximately 10% of programs. Faculty rated the value of nearly all types of clinical oncology exposure significantly lower than did students. Inclusion of the approaches identified in this study is likely to enhance PhD training in oncology-related disciplines. Cancer Res; 77(18); 4741-4. ©2017 AACR . ©2017 American Association for Cancer Research.

Introduction to the special section on dissemination: dissemination research and research dissemination: how can we close the gap?

PubMed

Kerner, Jon; Rimer, Barbara; Emmons, Karen

2005-09-01

One of the greatest challenges facing health promotion and disease prevention is translating research findings into evidence-based public health and clinical practices that are actively disseminated and widely adopted. Despite the tremendous strides made in developing effective disease prevention and control programs, there has been little study of effective dissemination of evidence-based programs to and adoption by community, public health, and clinical practice settings. This special section provides a venue in which to highlight exemplary dissemination research efforts while also identifying limitations in research to date and framing important future research questions. This issue establishes a resource for investigators interested in dissemination research, with relevance to health psychology. In this sense, it can serve as a benchmark by which to examine subsequent progress. The 6 articles reflect the state of the science in dissemination research for the promotion and adoption of health behavior change interventions. (c) 2005 APA, all rights reserved

Depletion of Alveolar Macrophages Does Not Prevent Hantavirus Disease Pathogenesis in Golden Syrian Hamsters

DTIC Science & Technology

2016-05-20

ANDV strain Chile -9717869 (27) was propagated in Vero E6 cells 122 (Vero C1008, ATCC CRL 1586). Preparation of twice-plaque-purified ANDV stock has...Research and Material Command, Military 537 Infectious Disease Research Program , Program Area T. Research reported in this publication 538 was also...prior to kidney, involvement, and diagnosed by viral 684 inclusions in lung macrophages. European journal of clinical microbiology & infectious

76 FR 51995 - National Center for Research Resources; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... Review Group, Comparative Medicine Review Committee, Comparative Medicine Review Committee. Date: October... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371...

A Case Study of Engaging Hard-to-Reach Participants in the Research Process: Community Advisors on Research Design and Strategies (CARDS)®.

PubMed

Kaiser, Betty L; Thomas, Gay R; Bowers, Barbara J

2017-02-01

Lack of diversity among study participants in clinical research limits progress in eliminating health disparities. The engagement of lay stakeholders, such as patient or community advisory boards (CABs), has the potential to increase recruitment and retention of underrepresented groups by providing a structure for gathering feedback on research plans and materials from this target population. However, many CABs intentionally recruit prominent stakeholders who are connected to or comfortable with research and academia and thus may not accurately represent the perspectives of underrepresented groups who have been labeled hard-to-reach, including racial minorities and low-income or low-literacy populations. We developed a partnership between the University of Wisconsin-Madison School of Nursing and two community centers to deliberately engage hard-to-reach people in two lay advisory groups, the Community Advisors on Research Design and Strategies (CARDS)®. Community center staff recruited the CARDS from center programs, including parenting and childcare programs, women's support groups, food pantries, and senior meal programs. The CARDS model differs from other CABs in its participants, processes, and outcomes. Since 2010, the CARDS have met monthly with nurses and other researchers, helping them understand how research processes and the language, tone, appearance, and organization of research materials can discourage people from enrolling in clinical studies. We have successfully used the CARDS model to bring hard-to-reach populations into the research process and have sustained their participation. The model represents a promising strategy for increasing the diversity of participants in clinical research. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Piloting a Nationally Disseminated, Interactive Human Subjects Protection Program for Community Partners: Design, Content, and Evaluation

PubMed Central

Eakin, Brenda; Kirk, Rosalind; Piechowski, Patricia; Thomas, Barbara

2014-01-01

Abstract Funders, institutions, and research organizations are increasingly recognizing the need for human subjects protections training programs for those engaged in academic research. Current programs tend to be online and directed toward an audience of academic researchers. Research teams now include many nonacademic members, such as community partners, who are less likely to respond to either the method or the content of current online trainings. A team at the CTSA‐supported Michigan Institute for Clinical and Health Research at the University of Michigan developed a pilot human subjects protection training program for community partners that is both locally implemented and adaptable to local contexts, yet nationally consistent and deliverable from a central administrative source. Here, the developers and the analysts of this program discuss its development, its content, and the results of its evaluation. PMID:24720288

Piloting a nationally disseminated, interactive human subjects protection program for community partners: design, content, and evaluation.

PubMed

Solomon, Stephanie; Eakin, Brenda; Kirk, Rosalind; Piechowski, Patricia; Thomas, Barbara

2014-04-01

Funders, institutions, and research organizations are increasingly recognizing the need for human subjects protections training programs for those engaged in academic research. Current programs tend to be online and directed toward an audience of academic researchers. Research teams now include many nonacademic members, such as community partners, who are less likely to respond to either the method or the content of current online trainings. A team at the CTSA-supported Michigan Institute for Clinical and Health Research at the University of Michigan developed a pilot human subjects protection training program for community partners that is both locally implemented and adaptable to local contexts, yet nationally consistent and deliverable from a central administrative source. Here, the developers and the analysts of this program discuss its development, its content, and the results of its evaluation. © 2014 Wiley Periodicals, Inc.

The value of formal clinical research training in initiating a career as a clinical investigator.

PubMed

Kapoor, Karan; Wu, Bechien U; Banks, Peter A

2011-12-01

The aim of this study was to determine whether formal clinical research training is of value in the initiation of a successful career as a clinical investigator. We conducted a retrospective review of the career choices of all 25 fellows who entered the Academic Clinical Research Track at Brigham and Women's Hospital since its inception in 1995 and examined the impact of formal clinical research training during their fellowship on their career choice. The primary measure of a successful career as a clinical investigator was the obtainment of external funding for clinical research within 3 years of completion of fellowship. Thirteen of the 25 fellows (52%) received a Master of Public Health (MPH) degree at the Harvard School of Public Health during their fellowship. Ten of these 13 fellows (77%) obtained external funding for clinical research within 3 years of completion of their fellowship. None of the 5 fellows who had already obtained an MPH degree prior to their fellowship and none of the 7 fellows who completed a 7-week summer Program in Clinical Effectiveness but did not complete an MPH degree attempted to receive external funding for clinical research within 3 years of completion of their fellowship. We conclude that formal clinical research training culminating in an MPH degree was extremely valuable in the initiation of a successful career as a clinical investigator.

Enrolling Minority and Underserved Populations in Cancer Clinical Research

PubMed Central

Wallington, Sherrie Flynt; Dash, Chiranjeev; Sheppard, Vanessa B.; Goode, Tawara D.; Oppong, Bridget A.; Dodson, Everett E.; Hamilton, Rhonda N.; Adams-Campbell, Lucile L.

2015-01-01

Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials—a “gold standard.” Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six non-therapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients—their physical locales, cultural values, and environments in which they live—is essential to recruiting culturally and ethnically diverse population samples. PMID:26470805

University of California Program for Analytical Cytology five-year report, 1982-1987

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stull, S.; Calkins, M.

1987-01-01

The Program for Analytical Cytology (PAC) was created by the Regents of the University of California on June 17, 1982. The purposes of the Program are to encourage research into theoretical, scientific, and engineering aspects of analytical cytology and into its biological and clinical applications.

75 FR 36785 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... national coverage determinations (NCDs) affecting specific medical and health care services under Medicare... notification, such as a particular clinical trial or research study that qualifies for Medicare coverage.... 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare-- Supplementary Medical Insurance...

Evaluating the Real-World Effectiveness of Cognitive-Behavior Therapy Efficacy Research on Eating Disorders: A Case Study from a Community-based Clinical Setting

PubMed Central

Lowe, Michael R.; Bunnell, Douglas W.; Neeren, Amy M.; Chernyak, Yelena; Greberman, Laurel

2009-01-01

Objective There is a growing consensus that there is a need to test the real-world effectiveness of eating disorder therapies that show promise in efficacy research. The current paper provides a narrative account of an NIMH-funded study that attempted to apply efficacy findings from CBT research to an Intensive Outpatient Program (IOP) at the largest community-based eating disorder program in the United States. Method We describe the study as originally envisioned as well as the various challenges that the researchers and the IOP staff encountered in implementing this study. Results The different training, assumptions, and “ways of knowing” of the research team and the treatment staff in regard to the nature of eating disorders and their treatment created multiple challenges for both groups during the study period. We describe valuable lessons learned about how to - and how not to -implement effectiveness designs in clinical settings that are relatively unfamiliar with empirically-based research findings. Discussion It is hoped that our experience in attempting to apply efficacy-based research findings on eating disorders treatment in a community-based clinical setting will prove helpful to other researchers and service providers engaging in such translational research. PMID:20063375

Information Warehouse – A Comprehensive Informatics Platform for Business, Clinical, and Research Applications

PubMed Central

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S.

2010-01-01

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC’s Clinical and Translational Science Award (CTSA) informatics program. PMID:21347019

The Science of Cancer Prevention

Cancer.gov

The science of cancer prevention is described by Dr. Barnett S. Kramer, M.D., M.P.H., director of the Division of Cancer Prevention, National Cancer Institute (NCI). The Division of Cancer Prevention administers a broad spectrum of research that spans basic pre-clinical, laboratory research, supportive and palliative care research, early detection, and randomized controlled clinical trials. The Division also supports the Cancer Prevention Fellowship Program and is devoted to the balanced communication of scientific results.

Generation of comprehensive thoracic oncology database--tool for translational research.

PubMed

Surati, Mosmi; Robinson, Matthew; Nandi, Suvobroto; Faoro, Leonardo; Demchuk, Carley; Kanteti, Rajani; Ferguson, Benjamin; Gangadhar, Tara; Hensing, Thomas; Hasina, Rifat; Husain, Aliya; Ferguson, Mark; Karrison, Theodore; Salgia, Ravi

2011-01-22

The Thoracic Oncology Program Database Project was created to serve as a comprehensive, verified, and accessible repository for well-annotated cancer specimens and clinical data to be available to researchers within the Thoracic Oncology Research Program. This database also captures a large volume of genomic and proteomic data obtained from various tumor tissue studies. A team of clinical and basic science researchers, a biostatistician, and a bioinformatics expert was convened to design the database. Variables of interest were clearly defined and their descriptions were written within a standard operating manual to ensure consistency of data annotation. Using a protocol for prospective tissue banking and another protocol for retrospective banking, tumor and normal tissue samples from patients consented to these protocols were collected. Clinical information such as demographics, cancer characterization, and treatment plans for these patients were abstracted and entered into an Access database. Proteomic and genomic data have been included in the database and have been linked to clinical information for patients described within the database. The data from each table were linked using the relationships function in Microsoft Access to allow the database manager to connect clinical and laboratory information during a query. The queried data can then be exported for statistical analysis and hypothesis generation.

Implementation successes and challenges in participating in a pragmatic study to improve colon cancer screening: perspectives of health center leaders.

PubMed

Coronado, Gloria D; Schneider, Jennifer L; Petrik, Amanda; Rivelli, Jennifer; Taplin, Stephen; Green, Beverly B

2017-09-01

Little is known about the challenges faced by community clinics who must address clinical priorities first when participating in pragmatic studies. We report on implementation challenges faced by the eight community health centers that participated in Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), a large comparative effectiveness cluster-randomized trial to evaluate a direct-mail program to increase the rate of colorectal cancer (CRC) screening. We conducted interviews, at the onset of implementation and 1 year later, with center leaders to identify challenges with implementing and sustaining an electronic medical record (EMR)-driven mailed program to increase CRC screening rates. We used the Consolidated Framework for Implementation Research to thematically analyze the content of meeting discussions and identify anticipated and experienced challenges. Common early concerns were patients' access to colonoscopy, patients' low awareness of CRC screening, time burden on clinic staff to carry out the STOP CRC program, inability to accurately identify eligible patients, and incompatibility of the program's approach with the patient population or organizational culture. Once the program was rolled out, time burden remained a primary concern and new organizational capacity and EMR issues were raised (e.g., EMR staffing resources and turnover in key leadership positions). Cited program successes were improved CRC screening processes and rates, more patients reached, reduced costs, and improved patient awareness, engagement, or satisfaction. These findings may inform any clinic considering mailed fecal testing programs and future pragmatic research efforts in community health centers.

A Matrix Mentoring Model That Effectively Supports Clinical and Translational Scientists and Increases Inclusion in Biomedical Research: Lessons From the University of Utah.

PubMed

Byington, Carrie L; Keenan, Heather; Phillips, John D; Childs, Rebecca; Wachs, Erin; Berzins, Mary Anne; Clark, Kim; Torres, Maria K; Abramson, Jan; Lee, Vivian; Clark, Edward B

2016-04-01

Physician-scientists and scientists in all the health professions are vital members of the U.S. biomedical workforce, but their numbers at academic health centers are declining. Mentorship has been identified as a key component in retention of faculty members at academic health centers. Effective mentoring may promote the retention of clinician-scientists in the biomedical workforce. The authors describe a holistic institutional mentoring program to support junior faculty members engaged in clinical and translational science at the University of Utah. The clinical and translational scholars (CATS) program leverages the resources of the institution, including the Center for Clinical and Translational Science, to augment departmental resources to support junior faculty investigators and uses a multilevel mentoring matrix that includes self, senior, scientific, peer, and staff mentorship. Begun in the Department of Pediatrics, the program was expanded in 2013 to include all departments in the school of medicine and the health sciences. During the two-year program, scholars learn management essentials and have leadership training designed to develop principal investigators. Of the 86 program participants since fiscal year 2008, 92% have received extramural awards, 99% remain in academic medicine, and 95% remain at the University of Utah. The CATS program has also been associated with increased inclusion of women and underrepresented minorities in the institutional research enterprise. The CATS program manifests institutional collaboration and coordination of resources, which have benefited faculty members and the institution. The model can be applied to other academic health centers to support and sustain the biomedical workforce.

PROPOSAL FOR A SIMPLE AND EFFICIENT MONTHLY QUALITY MANAGEMENT PROGRAM ASSESSING THE CONSISTENCY OF ROBOTIC IMAGE-GUIDED SMALL ANIMAL RADIATION SYSTEMS

PubMed Central

Brodin, N. Patrik; Guha, Chandan; Tomé, Wolfgang A.

2015-01-01

Modern pre-clinical radiation therapy (RT) research requires high precision and accurate dosimetry to facilitate the translation of research findings into clinical practice. Several systems are available that provide precise delivery and on-board imaging capabilities, highlighting the need for a quality management program (QMP) to ensure consistent and accurate radiation dose delivery. An ongoing, simple, and efficient QMP for image-guided robotic small animal irradiators used in pre-clinical RT research is described. Protocols were developed and implemented to assess the dose output constancy (based on the AAPM TG-61 protocol), cone-beam computed tomography (CBCT) image quality and object representation accuracy (using a custom-designed imaging phantom), CBCT-guided target localization accuracy and consistency of the CBCT-based dose calculation. To facilitate an efficient read-out and limit the user dependence of the QMP data analysis, a semi-automatic image analysis and data representation program was developed using the technical computing software MATLAB. The results of the first six months experience using the suggested QMP for a Small Animal Radiation Research Platform (SARRP) are presented, with data collected on a bi-monthly basis. The dosimetric output constancy was established to be within ±1 %, the consistency of the image resolution was within ±0.2 mm, the accuracy of CBCT-guided target localization was within ±0.5 mm, and dose calculation consistency was within ±2 s (± 3 %) per treatment beam. Based on these results, this simple quality assurance program allows for the detection of inconsistencies in dosimetric or imaging parameters that are beyond the acceptable variability for a reliable and accurate pre-clinical RT system, on a monthly or bi-monthly basis. PMID:26425981

Proposal for a Simple and Efficient Monthly Quality Management Program Assessing the Consistency of Robotic Image-Guided Small Animal Radiation Systems.

PubMed

Brodin, N Patrik; Guha, Chandan; Tomé, Wolfgang A

2015-11-01

Modern pre-clinical radiation therapy (RT) research requires high precision and accurate dosimetry to facilitate the translation of research findings into clinical practice. Several systems are available that provide precise delivery and on-board imaging capabilities, highlighting the need for a quality management program (QMP) to ensure consistent and accurate radiation dose delivery. An ongoing, simple, and efficient QMP for image-guided robotic small animal irradiators used in pre-clinical RT research is described. Protocols were developed and implemented to assess the dose output constancy (based on the AAPM TG-61 protocol), cone-beam computed tomography (CBCT) image quality and object representation accuracy (using a custom-designed imaging phantom), CBCT-guided target localization accuracy and consistency of the CBCT-based dose calculation. To facilitate an efficient read-out and limit the user dependence of the QMP data analysis, a semi-automatic image analysis and data representation program was developed using the technical computing software MATLAB. The results of the first 6-mo experience using the suggested QMP for a Small Animal Radiation Research Platform (SARRP) are presented, with data collected on a bi-monthly basis. The dosimetric output constancy was established to be within ±1 %, the consistency of the image resolution was within ±0.2 mm, the accuracy of CBCT-guided target localization was within ±0.5 mm, and dose calculation consistency was within ±2 s (±3%) per treatment beam. Based on these results, this simple quality assurance program allows for the detection of inconsistencies in dosimetric or imaging parameters that are beyond the acceptable variability for a reliable and accurate pre-clinical RT system, on a monthly or bi-monthly basis.

Postpartum depression: a chronicle of health policy development.

PubMed

Glasser, Saralee

2010-01-01

The current report presents an example of the path taken from identification of a public health problem at the primary health service level, to conducting research documenting the scope of the problem and nature of the risk factors, disseminating the findings, and fostering development and application of relevant policy. The example presented is the case of postpartum depression, an issue with bio-psycho-social implications. Public health nurses identified the problem, prompting epidemiological research. The findings encouraged the Ministry of Health (MOH) to conduct a pilot program for screening and early intervention among pregnant and postpartum women reporting depressive symptoms. Based on the results of the pilot program, the MOH is expanding the program to all Mother-Child Health (MCH) clinics. Israel?s largest Health Maintenance Organization has followed suit and is including this program in its own clinics. This Israeli experience may serve as an instructive example of a locally identified problem evolving into a national policy.

Outcomes of a Novel Training Program for Physician-Scientists: Integrating Graduate Degree Training With Specialty Fellowship.

PubMed

Wong, Mitchell D; Guerrero, Lourdes; Sallam, Tamer; Frank, Joy S; Fogelman, Alan M; Demer, Linda L

2016-02-01

Although physician-scientists generally contribute to the scientific enterprise by providing a breadth of knowledge complementary to that of other scientists, it is a challenge to recruit, train, and retain physicians in a research career pathway. To assess the outcomes of a novel program that combines graduate coursework and research training with subspecialty fellowship. A retrospective analysis was conducted of career outcomes for 123 physicians who graduated from the program during its first 20 years (1993-2013). Using curricula vitae, direct contact, and online confirmation, data were compiled on physicians' subsequent activities and careers as of 2013. Study outcomes included employment in academic and nonacademic research, academic clinical or private practice positions, and research grant funding. More than 80% of graduates were actively conducting research in academic, institutional, or industrial careers. The majority of graduates (71%) had academic appointments; a few (20%) were in private practice. Fifty percent had received career development awards, and 19% had received investigator-initiated National Institutes of Health (NIH) R01 or equivalent grants. Individuals who obtained a PhD during subspecialty training were significantly more likely to have major grant funding (NIH R series or equivalent) than those who obtained a Master of Science in Clinical Research. Trainees who obtained a PhD in a health services or health policy field were significantly more likely to have research appointments than those in basic science. Incorporation of graduate degree research, at the level of specialty or subspecialty clinical training, is a promising approach to training and retaining physician-scientists.

US medical specialty global health training and the global burden of disease

PubMed Central

Kerry, Vanessa B.; Walensky, Rochelle P.; Tsai, Alexander C.; Bergmark, Regan W.; Bergmark, Brian A.; Rouse, Chaturia; Bangsberg, David R.

2013-01-01

Background Rapid growth in global health activity among US medical specialty education programs has lead to heterogeneity in types of activities and global health training models. The breadth and scope of this activity is not well chronicled. Methods Using a standardized search protocol, we examined the characteristics of US medical residency global health programs by number of programs, clinical specialty, nature of activity (elective, research, extended curriculum based field training), and geographic location across seven different clinical medical residency education specialties. We tabulated programmatic activity by clinical discipline, region and country. We calculated the Spearman's rank correlation coefficient to estimate the association between programmatic activity and country–level disease burden. Results Of the 1856 programs assessed between January and June 2011, there were 380 global health residency training programs (20%) working in 141 countries. 529 individual programmatic activities (elective–based rotations, research programs, extended curriculum–based field training, or other) occurred at 1337 specific sites. The majority of the activities consisted of elective–based rotations. At the country level, disease burden had a statistically significant association with programmatic activity (Spearman's ρ = 0.17) but only explained 3% of the total variation between countries. Conclusions There were a substantial number of US medical specialty global health programs, but a relative paucity of surgical and mental health programs. Elective–based programs were more common than programs that offer longitudinal experiences. Despite heterogeneity, there was a small but statistically significant association between program location and the global burden of disease. Areas for further study include the degree to which US–based programs develop partnerships with their program sites, the significance of this activity for training, and number and breadth of programs in medical specialty global health education in other countries around the world. PMID:24363924

India's growing participation in global clinical trials.

PubMed

Gupta, Yogendra K; Padhy, Biswa M

2011-06-01

Lower operational costs, recent regulatory reforms and several logistic advantages make India an attractive destination for conducting clinical trials. Efforts for maintaining stringent ethical standards and the launch of Pharmacovigilance Program of India are expected to maximize the potential of the country for clinical research. Copyright © 2011. Published by Elsevier Ltd.

Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection

Cancer.gov

Utilizing Existing Clinical and Population Biospecimen Resources for Discovery or Validation of Markers for Early Cancer Detection, a 2013 workshop sponsored by the Epidemiology and Genomics Research Program.

The Role of Research in Viral Disease Eradication and Elimination Programs: Lessons for Malaria Eradication

PubMed Central

Breman, Joel G.; de Quadros, Ciro A.; Dowdle, Walter R.; Foege, William H.; Henderson, Donald A.; John, T. Jacob; Levine, Myron M.

2011-01-01

By examining the role research has played in eradication or regional elimination initiatives for three viral diseases—smallpox, poliomyelitis, and measles—we derive nine cross-cutting lessons applicable to malaria eradication. In these initiatives, some types of research commenced as the programs began and proceeded in parallel. Basic laboratory, clinical, and field research all contributed notably to progress made in the viral programs. For each program, vaccine was the lynchpin intervention, but as the programs progressed, research was required to improve vaccine formulations, delivery methods, and immunization schedules. Surveillance was fundamental to all three programs, whilst polio eradication also required improved diagnostic methods to identify asymptomatic infections. Molecular characterization of pathogen isolates strengthened surveillance and allowed insights into the geographic source of infections and their spread. Anthropologic, sociologic, and behavioural research were needed to address cultural and religious beliefs to expand community acceptance. The last phases of elimination and eradication became increasingly difficult, as a nil incidence was approached. Any eradication initiative for malaria must incorporate flexible research agendas that can adapt to changing epidemiologic contingencies and allow planning for posteradication scenarios. PMID:21311582

76 FR 29254 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

... Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

75 FR 32187 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-07

... Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

76 FR 28055 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Research...

75 FR 3741 - National Center for Research Resources; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-22

... Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Research...

76 FR 12123 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-04

... Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

75 FR 54895 - National Center for Research Resources; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

76 FR 59709 - National Center for Research Resources; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

76 FR 57748 - National Center for Research Resources; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... unwarranted invasion of personal privacy. Name of Committee: National Center for Research Resources Special...

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

PubMed Central

DuBois, James M.; Schilling, Debie A.; Heitman, Elizabeth; Steneck, Nicholas H.; Kon, Alexander A.

2010-01-01

Abstract The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE‐KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8‐item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources. PMID:20590680

Instruction in the responsible conduct of research: an inventory of programs and materials within CTSAs.

PubMed

DuBois, James M; Schilling, Debie A; Heitman, Elizabeth; Steneck, Nicholas H; Kon, Alexander A

2010-06-01

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.

Tenure Track Investigator | Center for Cancer Research

Cancer.gov

The Neuro-Oncology Branch (NOB), Center for Cancer Research (CCR) of the National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (HHS), Bethesda, MD, is actively recruiting for a tenure-track principal investigator to work in the area of immunology and/or immunotherapy.  The NOB Immunology/Immunotherapy Investigator will be tasked with forming and leading an independent research program.  This position will build the basic immunology program in the NOB and complement ongoing and planned translational research and clinical trials evaluating the effects of immunotherapy in patients with primary brain tumors.  This program will be able to access biospecimens generated from ongoing and planned immunotherapy protocols within the NOB, thus creating an opportunity to perform correlative studies to interrogate the complex biology of immunologic response, toxicity, and treatment resistance.  Demonstrated expertise in scientific inquiries in immunotherapy and/or immunology are essential, but prior work in brain tumors is not required.  This is an exciting opportunity to join a growing trans-institutional research team that promotes and supports collaborations across the basic, translational, and clinical research spectrum to develop novel therapeutics for individuals with primary central nervous system malignancies that will globally influence the field.

Research projects in the Surgeon-Scientist and Clinician-Investigator programs at the University of Toronto (1987-2016): a cohort study.

PubMed

Goldenberg, Neil M; Steinberg, Benjamin E; Rutka, James T; Chen, Robert; Cabral, Val; Rosenblum, Norman D; Kapus, Andras; Lee, Warren L

2016-01-01

Physicians have traditionally been at the forefront of medical research, bringing clinical questions to the laboratory and returning with ideas for treatment. However, we have anecdotally observed a decline in the popularity of basic science research among trainees. We hypothesized that fewer resident physicians have been pursuing basic science research training over time. We examined records from residents in the Surgeon-Scientist and Clinician-Investigator programs at the University of Toronto (1987-2016). Research by residents was categorized independently by 2 raters as basic science, clinical epidemiology or education-related based on the title of the project, the name of the supervisor and Pubmed searches. The study population was divided into quintiles of time, and the proportion pursuing basic science training in each quintile was calculated. Agreement between the raters was 100%; the categorization of the research topic remained unclear in 9 cases. The proportion of trainees pursuing basic science training dropped by 60% from 1987 to 2016 ( p = 0.005). Significantly fewer residents in the Surgeon-Scientist and Clinician-Investigator Programs at the University of Toronto are pursuing training in the basic sciences as compared with previous years.

The Role of the Clinical and Translational Science Awards Program in Improving the Quality and Efficiency of Clinical Research

PubMed Central

Rosenblum, Daniel

2011-01-01

Recognizing the need to increase the efficiency and quality of translating basic discovery into treatment and prevention strategies for patients and the public, the National Institutes of Health (NIH) announced the Clinical and Translational Science Awards (CTSAs) in 2006. Academic health centers that competed successfully for these awards agreed to work as a consortium and in cooperation with the NIH to improve the translation process by training the next generation of investigators to work in interdisciplinary teams, developing public-private partnerships in the movement of basic discovery to preclinical and clinical studies and trials, improving clinical research management, and engaging with communities to ensure their involvement in shaping research questions and in implementing research results. The CTSAs have addressed the crucial need to improve the quality and efficiency of clinical research by (1) providing training for clinical investigators and for bench researchers to facilitate their participation in the clinical and translational research environment, (2) developing more systematic approaches to clinical research management, and (3) engaging communities as active participants in the design and conduct of clinical research studies and trials and as leaders in implementing health advances that are of high importance to them. We provide an overview of the CTSA activities with attention to these three areas, which are essential to developing efficient clinical research efforts and effective implementation of research results on a national level. PMID:21896519

A review of standardized patients in clinical education: Implications for speech-language pathology programs.

PubMed

Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

2010-06-01

The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

Objective Methodology to Assess Meaningful Research Productivity by Orthopaedic Residency Departments: Validation Against Widely Distributed Ranking Metrics and Published Surrogates.

PubMed

Jones, Louis B; Goel, Sameer; Hung, Leroy Y; Graves, Matthew L; Spitler, Clay A; Russell, George V; Bergin, Patrick F

2018-04-01

The mission of any academic orthopaedic training program can be divided into 3 general areas of focus: clinical care, academic performance, and research. Clinical care is evaluated on clinical volume, patient outcomes, patient satisfaction, and becoming increasingly focused on data-driven quality metrics. Academic performance of a department can be used to motivate individual surgeons, but objective measures are used to define a residency program. Annual in-service examinations serve as a marker of resident knowledge base, and board pass rates are clearly scrutinized. Research productivity, however, has proven harder to objectively quantify. In an effort to improve transparency and better account for conflicts of interest, bias, and self-citation, multiple bibliometric measures have been developed. Rather than using individuals' research productivity as a surrogate for departmental research, we sought to establish an objective methodology to better assess a residency program's ability to conduct meaningful research. In this study, we describe a process to assess the number and quality of publications produced by an orthopaedic residency department. This would allow chairmen and program directors to benchmark their current production and make measurable goals for future research investment. The main goal of the benchmarking system is to create an "h-index" for residency programs. To do this, we needed to create a list of relevant articles in the orthopaedic literature. We used the Journal Citation Reports. This publication lists all orthopaedic journals that are given an impact factor rating every year. When we accessed the Journal Citation Reports database, there were 72 journals included in the orthopaedic literature section. To ensure only relevant, impactful journals were included, we selected journals with an impact factor greater than 0.95 and an Eigenfactor Score greater than 0.00095. After excluding journals not meeting these criteria, we were left with 45 journals. We performed a Scopus search over a 10-year period of these journals and created a database of articles and their affiliated institutions. We performed several iterations of this to maximize the capture of articles attributed to institutions with multiple names. Based off of this extensive database, we were able to analyze all allopathic US residency programs based on their quality research productivity. We believe this as a novel methodology to create a system by which residency program chairmen and directors can assess progress over time and accurate comparison with other programs.

From ecology to base pairs: nursing and genetic science.

PubMed

Williams, J K; Tripp-Reimer, T

2001-07-01

With the mapping of the human genome has come the opportunity for nursing research to explore topics of concern to the maintenance, restoration, and attainment of genetic-related health. Initially, nursing research on genetic topics originated primarily from physical anthropology and from a clinical, disease-focused perspective. Nursing research subsequently focused on psychosocial aspects of genetic conditions for individuals and their family members. As findings emerge from current human genome discovery, new programs of genetic nursing research are originating from a biobehavioral interface, ranging from the investigations of the influence of specific molecular changes on gene function to social/ethical issues of human health and disease. These initiatives reflect nursing's response to discoveries of gene mutations related to phenotypic expression in both clinical and community-based populations. Genetic research programs are needed that integrate or adapt theoretical and methodological advances in epidemiology, family systems, anthropology, and ethics with those from nursing. Research programs must address not only populations with a specific disease but also community-based genetic health care issues. As genetic health care practice evolves, so will opportunities for research by nurses who can apply genetic concepts and interventions to improve the health of the public. This article presents an analysis of the evolution of genetic nursing research and challengesfor the future.

PhD programs in nursing in the United States: visibility of American Association of Colleges of Nursing core curricular elements and emerging areas of science.

PubMed

Wyman, Jean F; Henly, Susan J

2015-01-01

Preparing nursing doctoral students with knowledge and skills for developing science, stewarding the discipline, and educating future researchers is critical. This study examined the content of 120 U.S. PhD programs in nursing as communicated on program websites in 2012. Most programs included theory, research design, and statistics courses. Nursing inquiry courses were evidenced on only half the websites. Course work or research experiences in informatics were mentioned on 22.5% of the websites; biophysical measurement and genetics/genomics were mentioned on fewer than 8% of program websites. Required research experiences and instruction in scientific integrity/research ethics were more common when programs had Institutional Training Award funding (National Institutes of Health T32 mechanism) or were located at a university with a Clinical and Translational Science Award. Changes in education for the next generation of PhD students are critically needed to support advancement of nursing science. Copyright © 2015 Elsevier Inc. All rights reserved.

Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya

PubMed Central

Tuti, Timothy; Bitok, Michael; Paton, Chris; Makone, Boniface; Malla, Lucas; Muinga, Naomi; Gathara, David; English, Mike

2016-01-01

Objective To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. Materials and methods The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals’ pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. Results In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. Conclusion A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research. PMID:26063746

Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya.

PubMed

Tuti, Timothy; Bitok, Michael; Paton, Chris; Makone, Boniface; Malla, Lucas; Muinga, Naomi; Gathara, David; English, Mike

2016-01-01

To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals' pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Public-academic partnerships: research in community mental health settings: a practicum experience for researchers.

PubMed

Miller, Alexander L; Lopez, Linda; Gonzalez, Jodi M; Dassori, Albana; Bond, Gary; Velligan, Dawn

2008-11-01

Applying research findings to community mental health practices is slowed by provider concerns that research participants often differ from community populations in duration of illness, comorbid conditions, and illness severity. Selecting participants from community settings makes research results demonstrably relevant, but researchers and community providers can be mistrustful of one another, feeling that the other has little understanding of their needs and work. This mistrust impedes patient referrals for research. This column describes a program to increase researcher knowledge of community clinic procedures through structured interactions with clinic personnel. Follow-up interviews indicate improved attitudes and cooperation of researchers and community providers.

NASA/Drexel program. [research effort in large-scale technical programs management for application to urban problems

NASA Technical Reports Server (NTRS)

1973-01-01

The results are reported of the NASA/Drexel research effort which was conducted in two separate phases. The initial phase stressed exploration of the problem from the point of view of three primary research areas and the building of a multidisciplinary team. The final phase consisted of a clinical demonstration program in which the research associates consulted with the County Executive of New Castle County, Delaware, to aid in solving actual problems confronting the County Government. The three primary research areas of the initial phase are identified as technology, management science, and behavioral science. Five specific projects which made up the research effort are treated separately. A final section contains the conclusions drawn from total research effort as well as from the specific projects.

Training and education in religion/spirituality within APA-accredited clinical psychology programs: 8 years later.

PubMed

Schafer, Rachel M; Handal, Paul J; Brawer, Peter A; Ubinger, Megan

2011-06-01

This study was a follow up investigation of Brawer et al.'s (Prof Psychol Res Pr 33(2):203-206, 2002) survey of education and training of clinical psychologists in religion/spirituality. Directors of clinical training were surveyed to determine whether changes had occurred in the coverage of religion and spirituality through course work, research, supervision, and in the systematic coverage of the content area. Results indicated an increased coverage in the areas of supervision, dedicated courses, inclusion as part of another course, and research. There was no increase in systematic coverage, but significantly more programs provided at least some coverage. The current study also assesses other areas of incorporation as well as directors' opinions regarding the importance of religion/spirituality in the field of psychology.

A Roadmap for Academic Health Centers to Establish Good Laboratory Practice-Compliant Infrastructure

PubMed Central

Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

2012-01-01

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials. PMID:22373618

A proposal to establish master's in biomedical sciences degree programs in medical school environments.

PubMed

Ingoglia, Nicholas A

2009-04-01

Most graduate schools associated with medical schools offer programs leading to the PhD degree but pay little attention to master's programs. This is unfortunate because many university graduates who are interested specifically in biomedical rather than pure science fields need further education before making decisions on whether to enter clinical, research, education, or business careers. Training for these students is done best in a medical school, rather than a graduate university, environment and by faculty who are engaged in research in the biomedical sciences. Students benefit from these programs by exploring career options they might not have previously considered while learning about disease-related subjects at the graduate level. Graduate faculty can also benefit by being compensated for their teaching with a portion of the tuition revenue, funds that can help run their laboratories and support other academic expenses. Faculty also may attract talented students to their labs and to their PhD programs by exposing them to a passion for research. The graduate school also benefits by collecting masters tuition revenue that can be used toward supporting PhD stipends. Six-year outcome data from the program at Newark show that, on completion of the program, most students enter educational, clinical, or research careers and that the graduate school has established a new and significant stream of revenue. Thus, the establishment of a master's program in biomedical sciences that helps students match their academic abilities with their career goals significantly benefits students as well as the graduate school and its faculty.

Building up careers in translational neuroscience and mental health research: Education and training in the Centre for Biomedical Research in Mental Health.

PubMed

Rapado-Castro, Marta; Pazos, Ángel; Fañanás, Lourdes; Bernardo, Miquel; Ayuso-Mateos, Jose Luis; Leza, Juan Carlos; Berrocoso, Esther; de Arriba, Jose; Roldán, Laura; Sanjuán, Julio; Pérez, Victor; Haro, Josep M; Palomo, Tomás; Valdizan, Elsa M; Micó, Juan Antonio; Sánchez, Manuel; Arango, Celso

2015-01-01

The number of large collaborative research networks in mental health is increasing. Training programs are an essential part of them. We critically review the specific implementation of a research training program in a translational Centre for Biomedical Research in Mental Health in order to inform the strategic integration of basic research into clinical practice to have a positive impact in the mental health system and society. Description of training activities, specific educational programs developed by the research network, and challenges on its implementation are examined. The Centre for Biomedical Research in Mental Health has focused on training through different activities which have led to the development of an interuniversity master's degree postgraduate program in mental health research, certified by the National Spanish Agency for Quality Evaluation and Accreditation. Consolidation of training programs within the Centre for Biomedical Research in Mental Health has considerably advanced the training of researchers to meet competency standards on research. The master's degree constitutes a unique opportunity to accomplish neuroscience and mental health research career-building within the official framework of university programs in Spain. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

DIABETES PREVENTION PROGRAM

EPA Science Inventory

The Diabetes Prevention Program (DPP) was a major clinical trial, or research study, aimed at discovering whether either diet and exercise or the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in people with impaired glucose toleranc...

Physician Assistant | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases a nd conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive, dedicated clinical research, nursing and physician support to the NCI’s Center for Cancer Research (CCR), Surgical Oncology section of the Thoracic and Gastrointestinal Oncology Branch (TGIB). KEY ROLES/RESPONSIBILITIES Complete in‐depth documentation through written progress notes, dictation summaries, and communication with referring physicians according to medical record documentation requirements. Participate in clinical rounds and conferences. Administer and adjust trial medication under the guidance of a physician. Explain discharge instructions and medication regimens to patients and follow up with consulting service recommendations. Order, perform and interpret basic laboratory diagnostic/treatment tests and procedures. Perform comprehensive health care assessments by obtaining health and family medical histories. Complete physical examinations. Perform minor surgeries (incisional and excisional biopsies). Distinguish between normal and abnormal findings and determine which findings need further evaluation and/or collaboration assessment. Develop and implement a plan for care, including appropriate patient/family counseling and education based on in-depth knowledge of the specific patient populations and/or protocols. Evaluate, modify and revise care plan at appropriate intervals. Assess acute and non‐acute clinical problems and toxicities. Ensure compliance with applicable licensure/certification requirements, healthcare standards, governmental laws and regulations, and policies, procedures, and philosophy in nature. Explain the plan of care/discharge needs to the incoming on‐call resident as well as the patient's assigned case manager at sign out. Independently evaluate patients in both the inpatient and outpatient clinic settings (all activities shall be performed in coordination with a government attending physician). Liaise with Leidos Biomed and various NCI staff to initiate and complete tasks relating to medicine and clinical protocols, and all activities related to nursing. Practice within boundaries established by the Nurse Practice Act or the State of Maryland and Medical Board of the Clinical Center, Review assigned patient resident reports and carry and answer the resident pager. Provide coverage for the post‐call resident’s patients, while working closely with the Inpatient/Fellowship staff. Write prescriptions. This position is located in Bethesda, Maryland.

A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

PubMed

Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

2017-06-01

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. Copyright © 2017 Elsevier Inc. All rights reserved.

NCI: DCTD: Biometric Research Branch

Cancer.gov

The Biometric Research Branch (BRP) is the statistical and biomathematical component of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC). Its members provide statistical leadership for the national and international research programs of the division in developmental therapeutics, developmental diagnostics, diagnostic imaging and clinical trials.

77 FR 59934 - National Cancer Institute; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

....396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399... Committee: National Cancer Institute Special Emphasis Panel; Minority-Based Community Clinical Oncology... Committee: National Cancer Institute Special Emphasis Panel; Exploratory/Developmental Research Programs in...

NCI: DCTD: Biometric Research Branch

Cancer.gov

The Biometric Research Branch (BRB) is the statistical and biomathematical component of the Division of Cancer Treatment, Diagnosis and Centers (DCTDC). Its members provide statistical leadership for the national and international research programs of the division in developmental therapeutics, developmental diagnostics, diagnostic imaging and clinical trials.

Education and training for medicines development, regulation, and clinical research in emerging countries

PubMed Central

Kerpel-Fronius, Sandor; Rosenkranz, Bernd; Allen, Elizabeth; Bass, Rolf; Mainard, Jacques D.; Dodoo, Alex; Dubois, Dominique J.; Hela, Mandisa; Kern, Steven; Massud, Joao; Silva, Honorio; Whitty, Jeremy

2015-01-01

The aim of this satellite workshop held at the 17th World Congress of Basic and Clinical Pharmacology (WCP2014) was to discuss the needs, optimal methods and practical approaches for extending education and teaching of medicines development, regulation, and clinical research to Low and Middle Income Countries (LMICs). It was generally agreed that, for efficiently treating the rapidly growing number of patients suffering from non-communicable diseases, modern drug therapy has to become available more widely and with a shorter time lag in these countries. To achieve this goal many additional experts working in medicines development, regulation, and clinical research have to be trained in parallel. The competence-oriented educational programs designed within the framework of the European Innovative Medicine Initiative-PharmaTrain (IMI-PhT) project were developed with the purpose to cover these interconnected fields. In addition, the programs can be easily adapted to the various local needs, primarily due to their modular architecture and well defined learning outcomes. Furthermore, the program is accompanied by stringent quality assurance standards which are essential for providing internationally accepted certificates. Effective cooperation between international and local experts and organizations, the involvement of the industry, health care centers and governments is essential for successful education. The initiative should also support the development of professional networks able to manage complex health care strategies. In addition it should help establish cooperation between neighboring countries for jointly managing clinical trials, as well as complex regulatory and ethical issues. PMID:25926798

WE-G-BRB-01: The Importance of NIH Funding in Innovation in Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Deye, J.

Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

WE-G-BRB-03: Innovating the Delivery of Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bortfeld, T.

2015-06-15

Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview willmore » be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH.« less

Accelerating Progress Against Cancer

Cancer.gov

Investment in cancer research is making a difference, but we still must overcome disparities in cancer incidence and mortality, and expand research to detect cancers earlier and develop more effective, less-toxic treatments. NCI supports research studies and programs across the country that are working to further advance cancer, research, and clinical care.

75 FR 80063 - National Center for Research Resources; Notice of Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research... U.S.C. App.), notice is hereby given of meetings of the National Advisory Research Resources Council...

Chair Report for the Committee on Research and Graduate Affairs.

ERIC Educational Resources Information Center

Broom, Arthur D.

1988-01-01

The report of the American Association of Colleges of Pharmacy's Committee on Research and Graduate Affairs addresses: graduate program evaluation, women's status in the pharmaceutical sciences, graduate student membership in the association, research needs and funding, animal use in research, a national health policy project, and clinical faculty…

Impact of the Surgical Research Methodology Program on surgical residents' research profiles.

PubMed

Farrokhyar, Forough; Amin, Nalin; Dath, Deepak; Bhandari, Mohit; Kelly, Stephan; Kolkin, Ann M; Gill-Pottruff, Catherine; Skot, Martina; Reid, Susan

2014-01-01

To evaluate whether implementing the formal Surgical Research Methodology (SRM) Program in the surgical residency curriculum improved research productivity compared with the preceding informal Research Seminar Series (RSS). The SRM Program replaced the RSS in July 2009. In the SRM Program, the curriculum in Year-1 consisted of 12 teaching sessions on the principles of clinical epidemiology and biostatistics, whereas the focus in Year-2 was on the design, conduct, and presentation of a research project. The RSS consisted of 8 research methodology sessions repeated annually for 2 years along with the design, conduct, and presentation of a research project. Research productivity was measured as the number of peer-reviewed publications and the generation of studies with higher levels of evidence. Outcome measures were independently assessed by 2 authors to avoid bias. Student t test and chi-square test were used for the analysis. Frequencies, mean differences with 95% CI, and effect sizes have been reported. In this study, 81 SRM residents were compared with 126 RSS residents. The performance of the SRM residents was superior on all metrics in our evaluation. They were significantly more productive and published more articles than the RSS residents (mean difference = 1.0 [95% CI: 0.5-1.5], p < 0.001) with an effect size of 0.26. The SRM residents presented significantly more projects that were of higher levels of evidence (systematic reviews/meta-analyses, randomized controlled trials, and prospective cohorts) than the RSS residents (52.5% vs 29%, p = 0.005). In addition, the research performance improved 11.0 grades (95% CI: 8.5%-13.5%, p < 0.001) with an effect size of 0.51 in favor of the SRM Program. Although not all surgeons opt for a career as surgeon-scientist, knowledge of research methodology is crucial to appropriately apply evidence-based findings in clinical practice. The SRM Program has significantly improved the research productivity and performance of the surgical residents from all disciplines. The implementation of a similar research methodology program is highly recommended for the benefit of residents' future careers and ultimately, evidence-based patient care. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Measuring outcomes of type 2 diabetes disease management program in an HMO setting.

PubMed

Ibrahim, Ibrahim Awad; Beich, Jeff; Sidorov, Jaan; Gabbay, Robert; Yu, Lucy

2002-01-01

There is a need to evaluate empirical disease management programs used in managing chronic diseases such as diabetes mellitus in managed care settings. We analyzed data from 252 patients with type 2 diabetes before and 1 year after enrollment in a disease management program. We examined clinical indicators such as HbA1C, HDL, LDL, total cholesterol, diastolic blood pressure, and BMI in addition to self-reported health status measured by SF-36 instrument. All clinical indicators showed statistically and clinically significant improvements. Only vitality and mental health showed statistically significant improvements in health status. Weak to moderate significant correlation between clinical indicators and health status was observed. Disease management can be effective at making significant clinical improvements for participants in a mixed-model HMO setting. No strong relationship between clinical indicators and health status was found. Future research is needed using a more specific health status measuring instrument and a randomized clinical trial design.

Linking scientific discovery and better health for the nation: the first three years of the NIH's Clinical and Translational Science Awards.

PubMed

Califf, Robert M; Berglund, Lars

2010-03-01

A comprehensive system for translating basic biomedical research into useful and effectively implemented clinical diagnostic, preventive, and therapeutic practices is essential to the nation's health. The state of clinical and translational research (CTR) in the United States, however, has been characterized as fragmented, slow, expensive, and poorly coordinated. As part of its Roadmap Initiative, the National Institutes of Health instituted the Clinical and Translational Science Awards (CTSA), a sweeping and ambitious program designed to transform the conduct of biomedical research in the United States by speeding the translation of scientific discoveries into useful therapies and then developing methods to ensure that those therapies reach the patients who need them the most. The authors review the circumstances of the U.S. biomedical research enterprise that led to the creation of the CTSA and discuss the initial strategic plan of the CTSA, which was developed from the first three years of experience with the program and was designed to overcome organizational, methodological, and cultural barriers within and among research institutions. The authors also describe the challenges encountered during these efforts and discuss the promise of this vital national health care initiative, which is essential to creating a pipeline for the scientific workforce needed to conduct research that will, in turn, provide a rational evidence base for better health in the United States.