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Two-Stage Optimal Designs With Survival Endpoint When The Follow-Up Time Is Restricted, Guogen Shan, Hua Zhang

Public Health Faculty Publications

Background: Survival endpoint is frequently used in early phase clinical trials as the primary endpoint to assess the activity of a new treatment. Existing two-stage optimal designs with survival endpoint either over estimate the sample size or compute power outside the alternative hypothesis space. Methods: We propose a new single-arm two-stage optimal design with survival endpoint by using the one-sample log rank test based on exact variance estimates. This proposed design with survival endpoint is analogous to Simon’s two-stage design with binary endpoint, having restricted follow-up. Results: We compare the proposed design with the existing two-stage designs, including the two-stage …