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Drug Evaluation After Marketing
- DENNIS SLONE, M.D.;
- SAMUEL SHAPIRO, M.B.;
- OLLI S. MIETTINEN, M.D., Ph.D.;
- WILLIAM D. FINKLE, Ph.D.; and
- PAUL D. STOLLEY, M.D.
Abstract
After marketing, drugs should be evaluated for safety and for efficacy. Present national systems are inadequate for both tasks. Safety can be evaluated by means of nonexperimental research, whereas evaluation of efficacy in a variety of settings representing normal medical practice generally requires experiments, randomized and blinded. Research into safety requires the maintenance of routine, yet flexible, multipurpose data systems, different for established and newly marketed drugs. Ad hoc studies on safety and on efficacy can be mounted more swiftly and economically through the maintenance of "standby" capabilities, in addition to maximal use of resources outside the actual national system.
Article and Author Information
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▸From the Drug Epidemiology Unit, Boston University School of Medicine; Cambridge, Massachusetts; the Department of Epidemiology, Harvard School of Public Health; Boston, Massachusetts; and the Department of Research Medicine, University of Pennsylvania School of Medicine; Philadelphia, Pennsylvania.
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▸Requests for reprints should be addressed to Dennis Slone, M.D.; Drug Epidemiology Unit, 10 Moulton Street; Cambridge, MA 02138.
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- Received November 27, 1978.
- Accepted November 28, 1978.
- ©1979 American College of Physicians
