NIH Has Implemented Key Provisions of the Clinical Research Enhancement Act
GAO-02-965: Published: Sep 18, 2002. Publicly Released: Sep 18, 2002.
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.
Recommendation for Executive Action
Status: Closed - Implemented
Comments: In a 2002 report describing the National Institutes of Health's (NIH) implementation of the Clinical Research Enhancement Act of 2000, GAO stated that NIH's reports of clinical research expenditures were not precise figures because the process of counting clinical research dollars varied widely across NIH's institutes and centers (ICs). GAO recommended that NIH strengthen its tracking and reporting of intramural and extramural expenditures for clinical research by developing and implementing a consistent, accurate, and practical way for all ICs to count intramural and extramural clinical research expenditures. In an October 18, 2002 memorandum to the ICs, the Director of NIH outlined clinical research coding methods to be used by all ICs beginning with their FY 2003 reporting of funding for clinical research. NIH reported that full implementation of this methodology was completed in January 2004. NIH implemented this methodology in order to respond to GAO's recommendation to make the reporting of clinical research transparent and rational and to provide accurate and consistent data.
Recommendation: To strengthen the tracking and reporting of intramural and extramural expenditures for clinical research, the Director of NIH should develop and implement a consistent, accurate, and practical way for all institutes and centers to count intramural and extramural clinical research expenditures.
Agency Affected: Department of Health and Human Services: Public Health Service: National Institutes of Health