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Activity Number: 37 - Statistical Issues Specific the Therapeutic Areas - 1
Type: Contributed
Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330601 Presentation
Title: Statistical Development in Addressing Delayed Treatment Effect or Crossing Survival Curves in Immuno-Oncology Clinical Trials
Author(s): Huyuan Yang*
Companies: Takeda Oncology Pharmaceutical
Keywords: Immuno-Oncology; delayed treatment effect; non-parametric; semi-parametric

How to reassess the efficacy and demonstrate the robustness of treatment effect with scientific sound methods is a challenging task for statisticians. In Immuno-Oncology clinical trials, treatment effect tends to be confound by delayed drug effect or crossing survival curves. In this presentation, different Non-parametric or semi-parametric approaches including milestone, weighted logrank, etc. are exercised. Survival curves with crossing and delayed effected are simulated for analysis purpose. Type I error control and power were studied through simulations Results show similar treatment effect and demonstrate the drug efficacy. Statistical inference based on p-values and confidence intervals of adjusted clinical endpoints take into consideration.

Methods will be recommended under different scenarios. The further development in this area can not only demonstrate the robustness of efficacy, but also help improving the efficiency in decision making in Phase I/II studies and access more information for pivotal study design.

Authors who are presenting talks have a * after their name.

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