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 a 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.