In 1994 the Institute of Medicine (IOM) issued a report on careers in clinical research that focused on three major issues: (1) accurate data on the numbers of clinical researchers, (2) career training support and funding, and (3) a systematic review of research administration and infrastructure (IOM, 1994). In 1995 NIH convened a director’s advisory panel to examine the challenges facing clinical research, such as financing, the role of clinical research centers, the recruitment and training of its workforce, and the conduct of clinical trials and peer review.
The actions produced by the recommendations of the advisory panel were instrumental in advancing clinical research in three ways. First, NIH adopted definitions for clinical research that allowed better collection of data, and it constructed a landscape view of who had taken up careers in clinical research (NRC, 2000). Second, NIH examined the composition and outcomes of study sections to ensure that clinical research proposals were being reviewed by those with clinical expertise. Third, NIH developed mechanisms for the training and support of clinical investigators (e.g., a series of K awards and the Clinical Research Loan Repayment Program).
More recently NIH embarked on an ambitious new plan for medical research in the twentieth-first century, the Roadmap for Accelerating Medical Discovery to Improve Health, which features a major emphasis on clinical research. Re-engineering the Clinical Research Enterprise aims to facilitate the bench-to-bedside transition through, among other things, enhanced regional clinical research centers that incorporate academic health centers as well as community-based healthcare providers, better organization of the gathering of clinical research information, better information technology, and ways to enhance the workforce. Within NIH itself, a panel to examine intramural clinical research has been established to provide guidance and review. (Intramural research is conducted within NIH laboratories. Extramural research is conducted by researchers at academic institutions that receive grants from the NIH.)
NIH has not changed the proportion of clinical research support since the launch of the NIH Director’s Panel on Clinical Research in 1996.1 By