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One-sided significance threshold of less than 0.1 in Phase 2 clinical trial

Datamethods Discussion Forum [Unofficial] February 24, 2026
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Doing a phase 2 RCT using one-sided significance threshold of less than 0.1 is acceptable? I always thought that a one-sided significance threshold of p < 0.10 (10% type I error rate), a meaningful departure from the conventional two-sided α = 0.05. One-sided testing assumes a priori that the experimental arm cannot be inferior to the control, and under the null hypothesis, one in ten trials would yield a positive result by chance alone. Curious to hear from the experts. For context this is the clinical called PARADIGM clinical trial in AML. https://ashpublications.org/blood/article/146/Supplement%201/6/553639/Results-from-paradigm-a-phase-2-randomized-multi

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