A comprehensive review of all phase III clinical trials supported by one Federal agency finds that, estimated conservatively, the economic benefit in the United States from just eight of these trials exceeded $15 billion over the course of 10 years. The study also found that new discoveries from the trials were responsible for an estimated additional 470,000 healthy years of life. The clinical trials were sponsored by the National Institutes of Health's National Institute of Neurological Disorders and Stroke (NINDS).
The study is one of the first to systematically analyze the impact of a publicly funded research program on medical care, public health, and health care costs. The analysis showed that the 10-year return on the investment in clinical trials research funding was 4600 percent. The researchers also found that the projected benefits of the clinical trial program during the period covered by this study were more than $50 billion - far greater than the total budget of the NINDS ($29.5 billion) during that period. The investment in most of the trials was returned through health benefits within 1.2 years after the trial funding ended.
"The results of this analysis demonstrate the return of the public investment in NIH research for the American people not only in economic terms, but in additional healthy years of life," says Elias A. Zerhouni, M.D., Director of the NIH. "We are transforming the practice of medicine by moving into an era when treatment will increasingly become more predictive, personalized, and preemptive."
"This study strongly suggests that, for this institute at least, the economic benefit from clinical trials more than offsets the total expenditures on clinical and basic research," says Story C. Landis, Ph.D., director of the NINDS.
The investigators, led by S. Claiborne Johnston, M.D., Ph.D., of the University of California, San Francisco, evaluated the costs and public heath benefits of all 28 phase III clinical trials supported by the NINDS between 1977 and 2000. The total cost of funding these trials was $335 million. The investigators reviewed publications on treatment utilization, societal cost, and health impact. When necessary, they supplemented the published data with other publicly available information from organizations that pool sales data, the companies that manufacture the drugs and devices tested, and disease-based non-profit organizations. Information on the utilization of the tested therapies and their impact on societal costs and savings or quality of life was available for just eight of these trials. The costs of the other 20 trials were included in the analysis, but their potential benefits were not. The study appears in the April 22, 2006, issue of The Lancet.*
"We tried as best we could to be very systematic and to estimate conservatively whenever an estimation was required. In spite of all that, we found that there was a tremendous positive impact from the program of clinical trials at NINDS," says Dr. Johnston.