The Clinician-Investigator Interface in Psychiatry: I — Values and Problems

1989 ◽  
Vol 34 (5) ◽  
pp. 361-363 ◽  
Author(s):  
Paul E. Garfinkel ◽  
David S. Goldbloom ◽  
Allan S. Kaplan ◽  
Sidney H. Kennedy

The two following papers describe some of the benefits and problems involved in integrating clinical and investigative work. It is stressed that there are a number of advantages to such integration. Researchers especially benefit from the proximity to patients and clinicians. Education can be significantly enhanced when researchers and clinicians are in one setting and this can benefit residents, medical students and non-medical health personnel. There are a number of problems to such clinical research in psychiatry. These are discussed especially as they relate to senior faculty and their resistances to research. The shortage of clinician scientists in teaching positions means that most residents are not involved with such people as mentors early in their training and do not consider this as a career option after their residency training. Reductionistic thinking on the part of some researchers and when researchers are not first-rate clinicians both contribute to residents not becoming involved in clinical investigation. Funding policies as well as chairmen's hiring policies also play a role here.

Author(s):  
Ali Al-saeed ◽  
Nasir Aldandan ◽  
Ahmed Qassimi ◽  
Muhammed Al-Alwan ◽  
Adeeb Buhlaigah ◽  
...  

Author(s):  
C. Madeira ◽  
L. Hořavová ◽  
F. dos Santos ◽  
J. R. Batuca ◽  
K. Nebeska ◽  
...  

Abstract Objectives Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. Methods A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. Results IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs’ publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). Conclusion The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.


Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 100555
Author(s):  
Mark P. Sendak ◽  
Michael Gao ◽  
William Ratliff ◽  
Krista Whalen ◽  
Marshall Nichols ◽  
...  

2007 ◽  
Vol 17 (1) ◽  
pp. 19-50 ◽  
Author(s):  
Laura Weiss Roberts ◽  
Teddy D. Warner ◽  
Laura B. Dunn ◽  
Janet L. Brody ◽  
Katherine A. Green Hammond ◽  
...  

2019 ◽  
Author(s):  
Laura V. Milko ◽  
Flavia Chen ◽  
Kee Chan ◽  
Amy M. Brower ◽  
Pankaj B. Agrawal ◽  
...  

ABSTRACTThe National Institutes of Health (NIH) funded the Newborn Sequencing In Genomic medicine and public HealTh (NSIGHT) Consortium to investigate the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period. Following announcement of the NSIGHT awardees in 2013, the Food and Drug Administration (FDA) contacted investigators and requested that pre-submissions to investigational device exemptions (IDE) be submitted for the use of genomic sequencing under Title 21 of the Code of Federal Regulations (21 CFR) part 812. IDE regulation permits clinical investigation of medical devices that have not been approved by the FDA. To our knowledge, this marked the first time the FDA determined that NIH-funded clinical genomic research projects are subject to IDE regulation. Here we review the history of and rationale behind FDA oversight of clinical research and the NSIGHT Consortium’s experiences in navigating the IDE process. Overall, NSIGHT investigators found that FDA’s application of existing IDE regulations and medical device definitions aligned imprecisely with the aims of publicly funded exploratory clinical research protocols. IDE risk assessments by the FDA were similar to, but distinct from, protocol risk assessments conducted by local Institutional Review Boards (IRBs), and had the potential to reflect novel oversight of emerging genomic technologies. However, the pre-IDE and IDE process delayed the start of NSIGHT research studies by an average of 10 months, and significantly limited the scope of investigation in two of the four NIH approved projects. Based on the experience of the NSIGHT Consortium, we conclude that policies and practices governing the development and use of novel genomic technologies in clinical research urgently need clarification in order to mitigate potentially conflicting or redundant oversight by IRBs, NIH, FDA, and state authorities.


Author(s):  
Garrett K Berger ◽  
John C Neilson ◽  
David M King ◽  
Adam N Wooldridge

Aim: To describe the efficacy of clinical research coordinators (CRCs) in terms of research output among faculty, residents and medical students. Materials & methods: We analyzed and reviewed departmental research output from the 3 years prior to the hire of 3 CRCs compared with the 3 years following. Results: From 2014 to 2016, the department output was a total of 27 peer-reviewed publications, 16 oral presentations and 33 poster presentations. From 2017–2019 there was a 52% increase in publications (n = 41), 131% increase in oral presentations (n = 37) and a 61% increase in poster presentations (n = 53). Conclusion: The implementation of CRCs has markedly increased tangible research output and trainee involvement. This role may serve as a valuable model for other academic departments.


2019 ◽  
Vol 3 (s1) ◽  
pp. 74-75
Author(s):  
Karen W. McCracken ◽  
Peter Mayinger ◽  
Cynthia Morris

OBJECTIVES/SPECIFIC AIMS: The aim of this program is to provide early support to motivated medical students interested in a career as a physician-scientist in a framework of competency-based medical education. The CTSA creates an opportunity to provide clinical research education and protected time for research for medical students in clinical and translational research. METHODS/STUDY POPULATION: This physician-scientist experience offers research opportunities in a wide variety of research disciplines, focused on clinical and translational investigations. The program offers both five-month and one-year blocks of protected research time. The five-month option is integrated into the four- year medical curriculum. The one-year option requires enrollment in an established Master of Clinical Research degree. Both options provide research experience under the mentorship of a physician-scientist. The five-month option aligns with UME competencies categorized under the six ACGME Domains of Competence. The one-year option includes coursework in research design, biostatistics, research ethics, data management, scientific communication, and proposal development within the CTSA-based education program. All students in the program attend a bimonthly journal club and seminar series starting in year one and extending through the research experience. This includes discussion of the importance of mentorship, selecting a residency, scientific writing and presentation, and personal narratives of physician-scientists and their pathways to this career. All students will be followed to determine career outcome. RESULTS/ANTICIPATED RESULTS: Between 2015 and 2018, 67 students entered the program 46% selected the year out, and 56% selected the 5-month option. Students selecting this program constitute about 10% of the medical student population overall. We have had 17 graduates of the program to date. 55% of the cohort is women which parallels the OHSU medical student population. Long-term follow-up of at least 10 years will be needed to determine career outcomes. We assess student productivity by traditional measures of submitted abstracts, manuscripts, and presentations as well as longer term outcomes such as career orientation in medicine such as entry into a research-oriented residency and ultimately into an academic medicine or research. DISCUSSION/SIGNIFICANCE OF IMPACT: The OHSU physician-scientist experience successfully matches medical students with a diverse set of research mentors focused on the CTSA. Although institutional structures determine the variety of specific research opportunities, the integration of physician-scientist training into a CTSA-based training program expands the reach of training programs such as the TL1.


2011 ◽  
Vol 35 (11) ◽  
pp. 425-429 ◽  
Author(s):  
Marie T. Curtis-Barton ◽  
John M. Eagles

Aims and methodThis cross-sectional study investigated the evolution of intentions among medical students to pursue a career in psychiatry and the factors that might discourage them from becoming a psychiatrist. A questionnaire survey was sent to medical students in years 1–5 at Aberdeen University.ResultsFrom 918 students, 467 (51%) returned useable responses. Proportions of students across the 5-year groups who definitely or probably intended to become psychiatrists remained fairly stable at 4–7%. In their final year, psychiatry remained a possible career option for a further 17% of students. The most potent discouraging factor was the perception of poor prognoses among psychiatric patients. Perceptions of a lack of scientific/evidence base reduced enthusiasm for becoming a psychiatrist. Issues relating to the prestige of the specialty were also important.ImplicationsIf recruitment to the specialty is to improve, these negative perceptions among students should be addressed by their teachers and more widely within psychiatry.


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