Adverse event detection in drug development: recommendations and obligations beyond phase 3.
Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record databases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing surveillance is essential for developing a full understanding of the balance between benefits and adverse effects. More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies.
Johnson & Johnson Pharmaceutical Research & Development, 1125 Trenton-Harbourton Rd, PO Box 200, Mail Stop K-304, Titusville, NJ 08560, USA. jberlin@prdus.jnj.com
Jesse A
JA
Berlin
Susan C
SC
Glasser
Susan S
SS
Ellenberg
D016907:Adverse Drug Reaction Reporting Systems; D017321:Clinical Trials, Phase I as Topic; D017326:Clinical Trials, Phase III as Topic; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D016021:Epidemiologic Studies; D006801:Humans; D007344:Insurance Claim Reporting; D040541:Marketing; D011358:Product Surveillance, Postmarketing / Q000379:methods*