Premarketing adverse drug experiences: data management procedures. Unexpected death occurring early in clinical trials

Drug Inf J. 1987;21(1):3-7. doi: 10.1177/009286158702100103.

Abstract

Reporting of adverse events occurring during clinical trials of investigational drugs is a complex and controversial issue. Even the interpretation of the term, "adverse event," cannot be agreed upon by researchers. The ultimate adverse event, death, presents even a greater challenge. This paper presents an actual case of death during a clinical trial to illustrate a methodological approach to deal with such an event.

MeSH terms

  • Clinical Trials as Topic*
  • Drug Evaluation / standards*
  • Drug Therapy / mortality
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • United States