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Abstract:
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A standard practice in randomized trials is to allocate subjects equally to the treatment arm and the control arm, with the purpose of maximizing the power and preventing bias introduction in estimating treatment effect. However in the development of cancer immunotherapy development, the experimental therapy is usually shown with superior efficacy signals in early phase trials. This fact raises the interest of patients, especially those patients who have limited hope, who will be eager to attend the trial. To ensure that patients will have higher probability to be allocated the more effective therapy and maximize the statistical power as well, this talk will discuss how to more appropriately do randomization. Theoretical approximation formula and recommendation for planning such a survival trial will also be provided.
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