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 shor...

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Bibliographic Details
Published in:American journal of public health (1971) 2008-08, Vol.98 (8), p.1366-1371
Main Authors: Berlin, Jesse A, Glasser, Susan C, Ellenberg, Susan S
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Biological and medical sciences
Clinical trials
Clinical Trials, Phase I as Topic
Clinical Trials, Phase III as Topic
Drug dosages
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Epidemiologic Studies
FDA approval
Humans
Insurance Claim Reporting
Laboratories
Marketing
Medical records
Medical sciences
Miscellaneous
Pharmaceutical industry
Pharmacovigilance
Product safety
Product Surveillance, Postmarketing - methods
Psoriasis
Public health
Public health. Hygiene
Public health. Hygiene-occupational medicine
Research Innovations and Recommendations
Studies
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Summary: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.
ISSN:0090-0036
1541-0048
DOI:10.2105/AJPH.2007.124537