ArticleClinical trials (London, England)2023
Futility monitoring for randomized clinical trials with non-proportional hazards: An optimal conditional power approach.
Article in Clinical trials (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundStandard futility analyses designed for a proportional hazards setting may have serious drawbacks when non-proportional hazards are present. One important type of non-proportional hazards occurs when the treatment effect is delayed. That is, there is little or no early treatment effect but a substantial later effect.
methodsWe define optimality criteria for futility analyses in this setting and propose simple search procedures for deriving such rules in practice.
resultsWe demonstrate the advantages of the optimal rules over commonly used rules in reducing the average number of events, the average sample size, or the average study duration under the null hypothesis with minimal power loss under the alternative hypothesis.
conclusionOptimal futility rules can be derived for a non-proportional hazards setting that control the loss of power under the alternative hypothesis while maximizing the gain in early stopping under the null hypothesis.
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