The discovery of drug-induced illness

N Engl J Med. 1977 Mar 3;296(9):481-5. doi: 10.1056/NEJM197703032960904.

Abstract

The increased use of drugs (and the concurrent increased risks of drug-induced illness) require definition of relevant research areas and strategy. For established marketed drugs, research needs depend on the magnitudes of risk of an illness from a drug and the base-line risk. With the drug risk high and the base-line risk low, the problem surfaces in premarketing studies or through the epidemic that develops after marketing. If the drug adds slightly to a high base-line risk, the effect is undetectable. When both risks are low, adverse effects can be discovered by chance, but systematic case-referent studies can speed discovery. If both risks are high, clinical trials and nonexperimental studies may be used. With both risks intermediate, systematic evaluations, especially case-referent studies are needed. Newly marketed drugs should be routinely evaluated through compulsory registration and follow-up study of the earliest users.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Disease Outbreaks / epidemiology
  • Disease Outbreaks / prevention & control
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • Follow-Up Studies
  • Humans
  • Iatrogenic Disease* / epidemiology
  • Iatrogenic Disease* / prevention & control
  • Male
  • Maternal-Fetal Exchange
  • Pregnancy
  • Research Design
  • Risk
  • United States