The paper formalizes dual-criterion phase II designs that require both statistical significance and a clinically relevant effect estimate, and gives sample size and operating-characteristic methods.
The ASA’s statement on p-values: Context, process, and purpose
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Beyond p-values: a phase II dual-criterion design with statistical significance and clinical relevance
The paper formalizes dual-criterion phase II designs that require both statistical significance and a clinically relevant effect estimate, and gives sample size and operating-characteristic methods.