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

DOI10.1111/biom.12324zbMath1419.62448OpenAlexW1560956491WikidataQ36955813 ScholiaQ36955813MaRDI QIDQ2803513

Martin Kulldorff, Ivair R. Silva

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)

Related Items (6)

Type I error probability spending for post-market drug and vaccine safety surveillance with Poisson data ⋮ Nearly optimal truncated group sequential test on binomial proportions ⋮ 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 ⋮ Exact conditional maximized sequential probability ratio test adjusted for covariates ⋮ Frequentist-Bayesian Monte Carlo test for mean vectors in high dimension ⋮ Complementary hypotheses in safety surveillance

Uses Software

• Sequential

Cites Work

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• A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance
• A sequential clinical trial for testing \(p_1=p_2\)
• Statistical monitoring of clinical trials. A unified approach.
• Curtailment in single-arm two-stage phase II oncology trials
• Testing one Simple Hypothesis Against Another
• Sequential Tests of Statistical Hypotheses

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