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Time‐to‐event analysis with treatment arm selection at interim
Author(s) -
Di Scala L.,
Glimm E.
Publication year - 2011
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4342
Subject(s) - interim analysis , frequentist inference , clinical endpoint , bonferroni correction , type i and type ii errors , interim , bayesian probability , computer science , selection (genetic algorithm) , statistics , medicine , bayesian inference , mathematics , clinical trial , machine learning , history , archaeology
This paper discusses the application of an adaptive design for treatment arm selection in an oncology trial, with survival as the primary endpoint and disease progression as a key secondary endpoint. We carried out treatment arm selection at an interim analysis by using Bayesian predictive power combining evidence from the two endpoints. At the final analysis, we carried out a frequentist statistical test of efficacy on the survival endpoint. We investigated several approaches (Bonferroni approach, ‘Dunnett‐like’ approach, a conditional error function approach and a combination p ‐value approach) with respect to their power and the precise conditions under which type I error control is attained. Copyright © 2011 John Wiley & Sons, Ltd.