Drug evaluation after marketing

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 require...

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Bibliographic Details
Published inAnnals of internal medicine Vol. 90; no. 2; p. 257
Main Authors Slone, D, Shapiro, S, Miettinen, O S, Finkle, W D, Stolley, P D
Format Journal Article
LanguageEnglish
Published United States 01.02.1979
Subjects
Drug and Narcotic Control
Drug Evaluation - standards
Drug-Related Side Effects and Adverse Reactions
Humans
Safety
Time Factors
United States
United States
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Summary: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.
ISSN:0003-4819
DOI:10.7326/0003-4819-90-2-257