Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance

DOI10.1111/BIOM.12324MaRDI QIDQ2803513zbMATH OpenOpenAlexWikidataFDO

Authors Ivair Silva, M. Kulldorff

Publication date 4 May 2016

Published in Biometrics (Search for Journal in Brave)

Full work available at URL http://europepmc.org/articles/pmc4888780

zbMATH Keywords

exact sequential analysisexpected time to signalpost-market safety surveillanceuniformly better sequential design

Mathematics Subject Classification ID

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

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Cites work

• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• scientific article; zbMATH DE number 1154646 (Why is no real title available?)
• scientific article; zbMATH DE number 3045589 (Why is no real title available?)
• A maximized sequential probability ratio test for drug and vaccine safety surveillance
• A sequential clinical trial for testing p₁=p₂
• Curtailment in single-arm two-stage phase II oncology trials
• Sequential Tests of Statistical Hypotheses
• Statistical monitoring of clinical trials. A unified approach.
• Testing one Simple Hypothesis Against Another

Cited in

(14)

• Nearly optimal truncated group sequential test on binomial proportions
• A maximized sequential probability ratio test for drug and vaccine safety surveillance
• Complementary hypotheses in safety surveillance
• Continuous readout versus titer-based assays of influenza vaccine trials: sensitivity, specificity, and false discovery rates
• Continuous post-market sequential safety surveillance with minimum events to signal
• A seasonality-adjusted sequential test for vaccine safety surveillance
• Alpha spending for historical versus surveillance Poisson data with CMaxSPRT
• Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data
• Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data
• Two-sample two-stage and purely sequential methodologies for tests of hypotheses with applications: comparing normal means when the two variances are unknown and unequal
• Type I error probability spending for post-market drug and vaccine safety surveillance with Poisson data
• The person-time ratio distribution for the exact monitoring of adverse events: historical vs surveillance Poisson data
• Frequentist-Bayesian Monte Carlo test for mean vectors in high dimension
• Exact conditional maximized sequential probability ratio test adjusted for covariates

Describes a project that uses

Uses Software

• Sequential

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