Grant applications for clinical trials,  clinical research centers, and clinical research training are typically  reviewed by the sponsoring institute; however, the peer review of  individual investigator grant applications usually takes place centrally,  within CSR. However, there was concern that  these awards were being directed toward basic research and were not  sufficiently supporting the training and development of clinical  investigators. Growth in NIH’s Spending on Clinical Research Has Kept Pace with Total Spending

NIH reports that it increased its funding of clinical research and expanded  its clinical research activities in response to CREA. NIH Has Taken Steps to Improve Its Peer Review of Clinical Research

Since passage of CREA, NIH has acted to strengthen its peer review of  clinical research applications. Although the two new clinical research study sections have been  welcomed by the research community, some concerns remain among  clinical investigators about the fairness of the review of clinical research  by other study sections that have a mix of clinical and basic research. Funding, Number, and Activities of GCRCs Have Increased

NIH has increased funding for the GCRC program, although funding for  the GCRCs has grown more slowly than NIH’s estimate of overall  expenditures on clinical research. Three of these have been implemented, and the fourth  is just beginning. NIH Has Established an Extramural Loan Repayment Program for Clinical Investigators

NIH has launched an extramural loan repayment program for clinical  investigators as required by CREA, and most of NIH’s ICs participate in the  program. NIH plans to fund  396 loan repayment contracts for a total of $20.2 million by the end of  fiscal year 2002. It has  increased its financial support of clinical research, expanded its clinical  research activities, made improvements in its review of clinical research  proposals, expanded its support of GCRCs, established new clinical  research career development and training programs, and begun to  implement a new extramural clinical research loan repayment program. Appendix I: NIH’s Estimated Expenditures for Extramural and Intramural Clinical Research, by IC, Fiscal Years 1997 - 2001

	Dollars in millions

Appendix II: NIH’s Extramural Clinical Research Loan Repayment Contracts by IC, Fiscal Year 2002

	Institutes and centers National Cancer Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Allergy and Infectious Diseases National Institute on Aging National Institute on Drug Abuse National Center for Research Resources National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development National Institute on Alcohol Abuse and Alcoholism National Institute of Neurological Disorders and Stroke National Institute of Arthritis and Musculoskeletal and Skin Diseases National Eye Institute National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Human Genome Research Institute National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Nursing Research National Center for Complementary and Alternative Medicine John E. Fogarty International Center Total

Appendix III: Comments from the National Institutes of Health
What GAO Found

Clinical research is critical for the development of strategies for the prevention, diagnosis, prognosis, treatment, and cure of diseases. Clinical research has been defined as patient-oriented research, epidemiologic and behavioral studies, and outcomes research and health services research. The National Institutes of Health (NIH) is the principal federal agency that funds clinical research supporting individual clinical investigators, clinical trials, general and specialized clinical research centers, and clinical research training. For many years, there have been concerns that clinical research proposals are viewed less favorably than basic research during the peer review process at NIH and that clinical research has not received its fair share of NIH funding. In November 2000, the Clinical Research Enhancement Act was enacted to address some of these concerns. NIH reports that it has increased its financial support of clinical research and that spending on clinical research has kept pace with total NIH research spending. NIH has taken some steps to improve its peer review of clinical research applications. The Center for Scientific Review recently added two new peer review study sections for the review of clinical research applications--one for clinical cardiovascular science and other for clinical oncology. NIH has increased its support of general clinical research centers, as required by the act, although the program has grown more slowly than NIH's overall estimated expenditures on clinical research. NIH has established the four clinical research career enhancement award programs mandated by the act. Three of these programs have been implemented, and they support new and midcareer clinical investigators and institutional clinical research teaching programs. The fourth program is designed to support graduate training in clinical investigation. NIH has initiated a new extramural loan repayment program specifically for clinical investigators as required by the act. This program was launched in December 2001. NIH received 456 applications by the February 2002 deadline. Twenty-one of NIH's institutes plan to fund 396 loan repayment contracts, for a total of $20.2 million, by the end of fiscal year 2002.