Premarketing adverse drug experiences: data management procedures. Unexpected death occurring early in clinical trials.
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.
D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000592:standards*; D004358:Drug Therapy / Q000401:mortality; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D014481:United States