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The extension of 2-in-1 adaptive phase 2/3 designs and its application in oncology clinical trials
1Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ 07033, USA.
Abstract:
A 2-in-1 adaptive Phase 2/3 design was proposed by Chen et al. The 2-in-1 design improves the overall clinical trial development efficiency by 1) building in an early and informative decision-making; 2) allowing the flexible endpoint-usage at the decision and the final analysis; 3) potential registration path forward in either Phase 2 or Phase 3. The original paper illustrates a general idea. In this paper, we extend this design to fit more common scenarios. The type I error control in the extended 2-in-1 adaptive Phase 2/3 designs is investigated in both simulation and theoretical ways.
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