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

DOI10.1111/BIOM.12324zbMATH Open1419.62448OpenAlexW1560956491WikidataQ36955813 ScholiaQ36955813MaRDI QIDQ2803513FDOQ2803513

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

Recommendations

• Continuous post-market sequential safety surveillance with minimum events to signal
• Type I error probability spending for post-market drug and vaccine safety surveillance with Poisson data
• Exact conditional maximized sequential probability ratio test adjusted for covariates
• A maximized sequential probability ratio test for drug and vaccine safety surveillance
• Wither group-sequential or time-sequential interim analysis in clinical trials?

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)

Cites Work

• Title not available (Why is that?)
• Sequential Tests of Statistical Hypotheses
• A maximized sequential probability ratio test for drug and vaccine safety surveillance
• A sequential clinical trial for testing \(p_1=p_2\)
• Title not available (Why is that?)
• Title not available (Why is that?)
• Testing one Simple Hypothesis Against Another
• Statistical monitoring of clinical trials. A unified approach.
• Curtailment in single-arm two-stage phase II oncology trials

Cited In (11)

• Nearly optimal truncated group sequential test on binomial proportions
• 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
• 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
• 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
• The person-time ratio distribution for the exact monitoring of adverse events: historical vs surveillance Poisson data
• Type I error probability spending for post-market drug and vaccine safety surveillance with Poisson data
• Exact conditional maximized sequential probability ratio test adjusted for covariates
• Frequentist-Bayesian Monte Carlo test for mean vectors in high dimension

Uses Software

• Sequential

This page was built for publication: Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance

Report a bug (only for logged in users!)Click here to report a bug for this page (MaRDI item Q2803513)