Premarketing Adverse Drug Experiences: Data Management Procedures
- 1 January 1987
- journal article
- other
- Published by Springer Nature in Drug Information Journal
- Vol. 21 (1) , 3-7
- https://doi.org/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.Keywords
This publication has 1 reference indexed in Scilit:
- Unexpected, unexplained death in epileptic patientsNeurology, 1975