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

zbMATH Open1373.62546arXiv1503.01978MaRDI QIDQ5364286FDOQ5364286

Authors: M. Kulldorff, Ivair Silva 

Publication date: 4 October 2017

Full work available at URL: https://arxiv.org/abs/1503.01978

Recommendations

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

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)

Cited In (8)

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

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