What question did this study set out to answer?

The study aims to evaluate the influence of response-adaptive randomization when using an imperfect intermediate endpoint.

February 26, 2026Clinical Trials

Response-adaptive randomization with imperfect intermediate endpoints

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Simulation explores the effects of response-adaptive randomization with intermediate endpoints in tuberculosis trials, indicating challenges.

The study aims to evaluate the influence of response-adaptive randomization when using an imperfect intermediate endpoint.
Simulated a response-adaptive randomization design for a superiority trial.
Used an intermediate endpoint of culture conversion at 8 weeks to update allocations.
Evaluated different sensitivity and specificity scenarios for the intermediate endpoint.
Assessed time-trends on type I error rate.
Perfect accuracy of the intermediate endpoint did not guarantee optimal patient allocation.
Lower accuracy of the intermediate endpoint led to reduced allocation to the better arm.
Greater treatment efficacy differences highlighted the impact of poor intermediate endpoint accuracy.
Time-trends increased type I error rate; stratified tests corrected this but reduced power.

Kherabi et al. (2026) studied this question.

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Simulation explores the effects of response-adaptive randomization with intermediate endpoints in tuberculosis trials, indicating challenges.