Interim analysis incorporating short- and long-term binary endpoints

DOI10.1002/BIMJ.201700281MaRDI QIDQ5208149zbMATH OpenOpenAlexWikidataFDO

Authors Julia Niewczas, Cornelia U. Kunz, Franz Koenig

Publication date 15 January 2020

Published in Biometrical Journal (Search for Journal in Brave)

Copyright license Creative Commons Attribution 4.0 International

Full work available at URL https://doi.org/10.1002/bimj.201700281

zbMATH Keywords

adaptive designscombination testconditional powerfutility stoppingsample size reassessment

Mathematics Subject Classification ID

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

Recommendations

• Incorporation of a stopping criterion for futility into the design of a clinical trial with one interim analysis
• Interim Analysis and Sample Size Reassessment
• Futility stopping in clinical trials
• Interim Analyses in 2 x 2 Crossover Trials
• scientific article; zbMATH DE number 1332897

Cited in

(9)

• Incorporation of a stopping criterion for futility into the design of a clinical trial with one interim analysis
• A note on penalty-free interim analyses of clinical studies with binary responses
• Monitoring Continuous Long-Term Outcomes in Adaptive Designs
• Estimation of conditional power in the presence of auxiliary data
• Sensitivity Analyses of Clinical Trial Designs: Selecting Scenarios and Summarizing Operating Characteristics
• Predicting outcomes of phase III oncology trials with Bayesian mediation modeling of tumor response
• Evaluating futility of a binary clinical endpoint using early read-outs
• Group sequential two-stage preference designs
• DOD-SSR: an adaptive seamless phase II/III design with dose optimization decision and sample size re-estimation

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