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AAMC Reporter: March 2005

John I. Gallin, M.D.
Director, National Institutes of Health (NIH) Clinical Center and NIH Associate Director for Clinical Research

Frederick P. Ognibene, M.D.
Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center and Director, Clinical Research Training Program

Viewpoint: "Nurturing the Next Generation of Clinical Researchers"

In order for clinical research to be carried out efficiently and effectively, physician-scientists and other members of the research team need to be equipped with the knowledge, skills and experience for it to be conducted in the highest quality manner by the largest number of individuals. Historically, clinical research training was not formalized, as it depended primarily upon mentors willing and able to share knowledge and advice on theory and techniques. This is a difficult and problematic approach in today's environment.

Advances in information technology mean unprecedented opportunities for processing and analyzing data. Ethical concerns are at the forefront of our society, which demands accountability among researchers, transparency in our processes and an absolute commitment to patient communication, safety and privacy. The demand for better medical treatments to be available in quicker fashion has escalated as patients become active partners in their own care.

These are central issues to the clinical research enterprise today, and it's long been obvious that yesterday's approaches to teaching medical students and young physicians about how to conduct clinical research aren't enough to meet today's demands.

For decades, discussions on how to provide this education focused on a few practical approaches. Typically topping the list are changes to what medical students study as undergraduates. Most useful would be classes that cover the basic principles of the discipline, including the basic epidemiological methods involved, ethical and legal issues, applicable regulations and how to prepare and fund a study. Ideally, instruction should be coupled with meaningful exposure to and involvement with the clinical research experience.

But changing what and how medical schools teach is an enormous undertaking that has been discussed at length elsewhere. If the traditional four years of class work are extended, there must be greater support for loan repayment programs. Undergraduate didactics must be coupled with practical, hands-on experience. Advanced degree programs such as masters programs in clinical research and joint MD/PhD degree programs are more plentiful today but still require the precious investment of time as well as money.

Distance learning and academic collaborations, existent in some academic centers, are cost- and time-efficient approaches to providing educational opportunities for physician-scientists already immersed in medical careers and are a means to capture large numbers of potential clinical researchers at early points in their career development.

While the academic discussions continue, programs now underway can help stimulate and sustain students' awareness of and interest in the clinical research enterprise. One program designed to achieve this goal the Clinical Investigator Student Trainee Forum was launched in 2003 to emphasize the importance of translational and clinical research. Investigators from the National Institutes of Health (NIH) and academic medical centers comprise the forum faculty. Lectures, workshops, and panel discussions offer opportunities for students to learn about what's involved in clinical research and career paths associated with it.

To date, in the two years of its existence, participants have included Howard Hughes Medical Institute's scholars and fellows; Doris Duke Clinical Research Program medical students; General Clinical Research Center medical students in 12-month research programs; Sarnoff Endowment for Cardiovascular Science fellows; and the NIH Clinical Research Training Program for Medical and Dental Student fellows. Public and private funds support the forum.

The Hughes, Doris Duke, Sarnoff and NIH programs, as well as others like it, are invaluable to answering the need for more and better-prepared clinical researchers. Students who participate have the time, resources and financial support to devote a significant portion of their educational development to immersion in the conduct of clinical research. They work in real-life, real-time situations with experienced physician-scientists.

In 1925 educator Abraham Flexner wrote, "Research can no more be divorced from medical education than can medical education be divorced from research." Eighty years later, his comments still reflect the current reality of medical education and medical research. Early capture through formal programs for peers, such as the Clinical Investigator Student Trainee forum, and long distance learning methods to reach large numbers of young investigators in order to provide a formal clinical research curriculum are two methods to nurture and train students and future clinical investigators.