Continuous post-market sequential safety surveillance with minimum events to signal.
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Date
2017
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Abstract
Continuous sequential analysis is increasingly used for near real-time post-market
drug and vaccine safety surveillance. We explore continuous sequential monitoring
when the null cannot be rejected until a minimum number of adverse events have
occurred. For fixed alpha, one can simultaneously increase the statistical power and
reduce the expected time to signal. We also evaluate continuous sequential analysis
with a delayed start until a certain sample size has been attained. This is only useful if
the start of the surveillance is delayed for logistical reasons. Tables with exact critical
values, statistical power and the average times to signal are provided.
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Keywords
Drug safety, Surveillance, Pharmacovigilance, Continuous sequential analysis
Citation
KULLDORFF, M.; SILVA, I. R. Continuous post-market sequential safety surveillance with minimum events to signal. REVSTAT - Statistical Journal, v. 15, p. 373-394, 2017. Disponível em: <https://www.ine.pt/revstat/pdf/REVSTAT_v15-n3-4.pdf>. Acesso em: 16 jan. 2018.