Continuous post-market sequential safety surveillance with minimum events to signal

MaRDI QIDQ5364286zbMATH OpenFDO

Authors M. Kulldorff, Ivair Silva

Publication date 4 October 2017

Full work available at URL https://arxiv.org/abs/1503.01978, https://www.ine.pt/revstat/pdf/REVSTAT_v15-n3-4.pdf

zbMATH Keywords

surveillancedrug safetypharmacovigilancesequential probability ratio testcontinuous sequential analysis

Mathematics Subject Classification ID

Parametric hypothesis testing (62F03) Applications of statistics to biology and medical sciences; meta analysis (62P10) Sequential statistical analysis (62L10)

Recommendations

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(8)

• A seasonality-adjusted sequential test for vaccine safety surveillance
• Type I error probability spending for post-market drug and vaccine safety surveillance with Poisson data
• A maximized sequential probability ratio test for drug and vaccine safety surveillance
• Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance
• Complementary hypotheses in safety surveillance
• Efficient score statistic in drug and vaccine safety surveillance
• Exact conditional maximized sequential probability ratio test adjusted for covariates
• Active postmarketing drug surveillance for multiple adverse events

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