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Abstract:
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In cancer treatment landscape, immunotherapy has become an emerging field in recent years with greater clinical success. However, a delayed separation of overall survival curves has been commonly found in immunotherapy randomized trials which poses a great challenge in study design and leads to a great power loss if it's not accounted for. It is desirable to optimize the study design to claim the success of the trial at earliest timing when sufficient information is accumulated if the immunotherapy is truly efficacious. The analysis timing should be evaluated to account for the delayed treatment effect to ensure clinical success. In this work, optimizing analysis timing will be illustrated using a hypothetical clinical trial example.
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