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Full-Text Articles in Medicine and Health Sciences
Two-Stage Optimal Designs With Survival Endpoint When The Follow-Up Time Is Restricted, Guogen Shan, Hua Zhang
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 …
Statistical Advances In Clinical Trials And Clinical Research, Guogen Shan, Sarah Banks, Justin B. Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo, Jeffrey L. Cummings
Statistical Advances In Clinical Trials And Clinical Research, Guogen Shan, Sarah Banks, Justin B. Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo, Jeffrey L. Cummings
Public Health Faculty Publications
Introduction New treatments for neurodegenerative disease are urgently needed, and clinical trial methods are an essential component of new drug development. Although a parallel-group study design for neurological disorder clinical trials is commonly used to test the effectiveness of a new treatment as compared to placebo, it does not efficiently use information from the on-going study to increase the success rate of a trial or to stop a trial earlier when the new treatment is indeed ineffective. Methods We review some recent advances in designs for clinical trials, including futility designs and adaptive designs. Results Futility designs and noninferiority designs …