Interim analyses and early termination of clinical trials

DOI10.1080/10543409708835205MaRDI QIDQ4390771zbMATH OpenOpenAlexWikidataFDO

Authors Sung C. Choi

Publication date 15 March 1999

Published in Journal of Biopharmaceutical Statistics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1080/10543409708835205

zbMATH Keywords

clinical trialsdelayed observationsearly terminationfutility analysesgroup sequential testsinterim analyses

Mathematics Subject Classification ID

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

Recommendations

• Interim and terminal analyses of clinical trials with failure-time endpoints and related group sequential designs
• Futility stopping in clinical trials
• An overview of sequential methods and their application in clinical trials
• Incorporation of a stopping criterion for futility into the design of a clinical trial with one interim analysis
• Statistical approaches to interim monitoring of medical trials: A review and commentary

Cites work

• Discrete Sequential Boundaries for Clinical Trials
• Monitoring Clinical Trials Based on Predictive Probability of Significance
• Sequential Analysis with Delayed Observations
• Stochastically curtailed tests in long–term clinical trials

Cited in

(6)

• Futility stopping in clinical trials
• Interim and terminal analyses of clinical trials with failure-time endpoints and related group sequential designs
• Early Stopping by Using Stochastic Curtailment in a Three-Arm Sequential Trial
• Incorporation of a stopping criterion for futility into the design of a clinical trial with one interim analysis
• Interphase Clinical Trials: Phase III/Phase IV
• A note on penalty-free interim analyses of clinical studies with binary responses

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