Adverse Event Detection in Drug Development: Recommendations and Obligations Beyond Phase 3

AUTOR(ES)

Berlin, Jesse A.

FONTE

American Public Health Association

RESUMO

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.

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