In 1995, Harold E. Varmus, who was then the director of the National Institutes of Health (NIH), convened the NIH Director’s Panel on Clinical Research. The panel was charged with making recommendations to foster the NIH’s support of clinical research, a field that was pervaded by discouragement and believed to be in jeopardy. 1-4 The panel met between July 1995 and November 1997, when it issued a series of recommendations. 2, 5 In this article, we review these recommendations, inventory the changes made within the NIH and in clinicalresearch portfolios within the private sector since 1995, and assess the effects of these changes.

The panel defined clinical research as studies of living human subjects, including the laboratory-based development of new forms of technology; studies of the mechanisms of human disease and evaluations of therapeutic interventions (which are known collectively as translational research); clinical trials, outcome studies, and health care research; and epidemiologic and behavioral studies. 2 The definition excluded disease-oriented studies of tissue samples obtained from individual patients or groups of patients who were unknown to the investigators. On the basis of this definition of clinical research, the panel recommended the establishment of programs for clinical-research training of medical students, postgraduate training programs (funded by K30 grants) in the methods and ethics of clinical research, research grant support for young clinical investigators (funded by K23 grants), grant support for experienced clinical researchers who act as mentors (funded by K24 grants), the restructuring of the study sections that review applications for clinical-research grants, increased responsibility within the General Clinical Research Center program for ensuring the high quality of clinical research, and educational-debt relief for young clinical investigators, including those who are members of minority