Meeting the Challenges Facing Clinical Research: Solutions Proposed by Leaders of Medical Specialty and Clinical Research Societies

Abstract

The development of a robust national clinical research enterprise is needed to improve health care, but faces formidable challenges. To define the impediments and formulate solutions, the Institute of Medicine's Clinical Research Roundtable convened leaders from medical specialty and clinical research societies in 2003. Participants considered how to influence clinical research funding priorities, promote mechanisms to train physicians and other health care professionals to conduct clinical research, and how to encourage health care providers to follow evidence-based medical practice. Consensus emerged on multiple issues, including intersociety collaboration, the need for a core clinical research curriculum for training the new cadre of clinical researchers, joint advocacy for increased funding of clinical research and for the education of policymakers and the public on the benefits of clinical research. Specific recommendations were made on mechanisms for recruitment, training, and retention of clinical research trainees and mentors. Steps were outlined (1) to overcome career disincentives and develop appropriate reward systems for mentors and trainees, (2) to encourage use of web-based and continuing-medical-education-based mechanisms to bring practitioners up to date on issues in and results of clinical research, and (3) to create incentives for individuals, clinics, and hospitals to practice evidence-based medicine (EBM). Collectively, the response and proposed strategies can serve as a roadmap to improve clinical research funding and training, evidence-based medical practice, and health care quality.

A Clinical Vision Research Training and Mentoring Program as a Model for Ophthalmology and Other Medical Specialties: Implementation and Evaluation

“…3 In recent decades, attempts to address this shortage have included formalizing research training during clinical years to ensure that it remains a career-long priority. 4 Several expert committees-including the NIH Director's Panel on Clinical Research, 5 the Institute of Medicine's Clinical Research Roundtable, 6 and the Association of American Medical Colleges' second Clinical Research Task Force (CRTFII) 7 -have generated recommendations and funding mechanisms for implementing clinical research education in the United States. Specific points highlighted by these expert panels include the need for a structured, didactic curriculum that incorporates a core knowledge base; practical clinical research experience; mentorship opportunities; protected research time for mentors; and formal recognition, such as a certificate or master's degree.…”

“…All of these panels emphasize the importance of introducing medical students and physicians to clinical research as early as possible in their training. [5][6][7] The creation of the National Eye Institute (NEI) in 1968 was a seminal event for vision research. The NEI legitimized the field of ophthalmic research, its research budget growing from $24 million in 1970 to $500 million in 2000 and to $708 million in 2017.…”

Commentary: Physician–Scientist's Frustrations Fester

“…Lastly, young physicians are carrying extreme burdens of debt accumulated during their medical education, whereas managed care has imposed constraints on the system of medical education for students (Ludmerer, 1999), residents, and fellows (at a time when resident hours are severely reduced; Education, 2002), and the numbers of nursing personnel are at an all time low (Aiken et al, 2002); the prospects of receiving good medical care have never looked more worrisome. Interestingly, a recent survey of physicians and patients reported that what concerned them most about today's health care was not medical errors but rather costs of malpractice, lawsuits, cost of health care, and the cost of prescription drugs (see Blendon et al, 2008;Murillo et al, 2006;O'Kane et al, 2008).…”

Report of the AACP Educating Clinical Scientists Task Force

“…[22][23][24] Lack of a clinical research infrastructure, new regulations on the use of human subjects in research, and surprisingly, a ''lack of respect'' for clinical research involving human subjects were identified as impediments. [25][26][27] The ''lack of respect'' theme reemerged at a 2005 NIH-sponsored conference which discussed options for increasing and improving clinical research and appears to be the major reason for requiring an independent academic home (Center, Institute, Department) for clinical research in the NIH Request for Proposal for the Clinical and Translational Science Awards (CTSAs). CRTF II, which conducted its work at approximately the same time as the RFA for the Clinical and Translational Science Awards (CTSA) was issued, but before the first CTSA awards were made, addressed many of the same issues posed to the AACP Educating Clinical Scientist Task Force, particularly the appropriate type of education/training for a clinical scientist.…”