What question did this study set out to answer?

This research addresses the need for effective trial designs that evaluate two co-primary endpoints in phase 2 clinical trials.

Exact Randomized Two‐Stage Phase 2 Clinical Trial Designs for Two Binary Co‐Primary Endpoints

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Clinical trial designs assess treatment efficacy across two co-primary binary endpoints, suggesting a new efficient method for design.

This research addresses the need for effective trial designs that evaluate two co-primary endpoints in phase 2 clinical trials.
Developed exact and simulation-based methods for two-arm, two-stage phase 2 trials
Utilized the bivariate binomial distribution to account for correlations between endpoints
Identified optimal designs that minimize expected sample size
Analyzed performance of simulation-based and normal approximation methods against exact computations
Exact method provides analytically exact operating characteristics for small sample sizes
Simulation-based method generates designs closely matching those from the exact method
Normal approximation often deviates from optimal designs
Recommendation for simulation-based approaches as efficient alternatives for larger samples.

Jung et al. (2026) studied this question.

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