Education for Physician Clinical Researchers: Should One Size Fit All?

Abstract

Over the past decade, there has been an expansion of clinical research education programs. Previously, in contrast to bench science education, clinical research education was obtained primarily through apprenticeship. Physician trainees in clinical research worked with experienced clinical researchers to gain expertise. As physicians already had a graduate degree and as this degree prepared them to clinically care for patients, it was assumed that it also prepared them to perform human investigation. The Association of American Medical Colleges has urged medical schools and teaching hospitals to provide structured advanced educational clinical research programs for physicians. While many successful physician bench scientists have been trained by apprenticeship, MD-PhD programs exist where formal training is provided. One such model, the Medical Scientist Training Program (MSTP) has been funded by NIH since 1963 to address the need for investigators trained in research and medicine. Success of this program has been reflected in the number of graduates pursuing research careers. MSTP graduates had increased number of NIH grants submitted and awarded and increased number of publications.1 Although the goal of MSTPs is to educate both bench and clinical researchers, the vast majority of students are engaged in bench research. MSTP mentors have been almost exclusively bench scientists, thus providing the student primarily exposure to bench research. Secondly, since these mentors are successful bench scientists, it was natural for the students to follow a similar career path.2 Third, medical school may not be the optimal time for training patient-oriented researchers as students usually will not have the clinical skills to independently interact with patients. It is expected that clinical research education would be of benefit to clinical researchers based on parallels with physician bench scientists who have PhDs. Individuals with only MD degrees have been shown to be less successful in obtaining NIH RO1 funding than MD-PhDs and PhDs.3 The Association of American Medical Colleges has urged medical schools and teaching hospitals to provide structured advanced educational clinical research programs for physicians.4 In considering clinical research education, it is important to recognize two major categories: population-oriented and patient-oriented. For several decades, many physicians have received training in population-oriented clinical research through degree-granting programs such as the Masters in Public Health (MPH). With the Clinical Research Enhancement Act of 2000, the NIH created the Clinical Research Curriculum Award (CRCA-K30), the goal of which was for institutions to develop formal curricula to train clinical investigators including patient-oriented researchers. These programs provide structured education corresponding to that which MPH programs provide population-oriented clinical researchers and PhD programs provide bench scientists. However, unlike the MSTP and other PhD programs, most do not provide a stipend, although some require that the home institution do so. Whether graduates of the K30 programs are more successful in obtaining research funding and more likely to sustain research careers is not yet known. Less intensive nondegree clinical research education is an alternative. Such programs often culminate in the receipt of a certificate.5 Their intensity varies from short courses of several hours to more prolonged exposure such as the Harvard Program in Clinical Effectiveness, a full-time summer program.6 As they are less intensive than degree programs, they can be undertaken with less interruption of other activities. Some of the certificate programs are offered online so that they can be taken at the individual's own pace. These courses may be ideal for physicians who participate in clinical research but not as their primary career focus. How will we know which models are most successful in training clinical researchers? It will be important to collect objective data on program graduates as has been done for MSTPs and programs such as the Harvard Program in Clinical Effectiveness.6 This assessment will need to include measures of persistence and success in independent clinical research careers. An important contrast will be MDs who are engaged in clinical research who were trained in degree-granting programs versus those who were not. Degree and nondegree clinical research education programs each have advantages and drawbacks. Although the degree programs provide a more comprehensive clinical research education, they may not be feasible for many clinical investigators. First, there is a paucity of physicians engaged in clinical research7,8 and the number of degree-granting programs is limited. Even if these programs expand, it is unlikely that there will be enough capacity to provide a trained clinical investigator workforce. Second, many do not have access to degree programs because of geography. Third, educational programs have substantial costs, which make them prohibitive for many. Fourth, even when tuition cost is covered, there may be a lack of income during the educational program. When these programs are undertaken during fellowship, the participants often have support for their salary, but not when the individual is in a post-fellowship position. There are several solutions to these issues. Using the MSTP stipend approach may provide a solution to the cost issue. However, it is clear that to meet the person power needs in clinical research both near- and long-term, the availability of educational programs of varying time commitment and depth are required. One size need not fit all.