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Activity Number: 308 - Adaptive Design - 2
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329753 Presentation
Title: Basket Trials Design and Analysis in Non-Oncology Therapeutical Areas
Author(s): Binbing Yu* and Jingjing Chen and Dewei She and Jianliang Zhang
Companies: MedImmune/AstraZeneca and Takeda Pharmaceuticals and MedImmune/AstraZeneca and Medimmune, LLC
Keywords: Autoimmune disease; Basket trials; Hierarchical model

Basket trials are an emerging and involving clinical trial design that evaluate target agents in multiple malignancies or diseases. The basket trials offer a cost-effective option to evaluate and identify a potentially favorable treatment effect for a sub-cohort with a certain indication or mutation. The basket trials have been successfully applied to oncology area, particularly in the exploratory and early phase of clinical trials. Here, we explore the application of basket trial design and analysis beyond the realm of oncology. In addition, we consider the mixed type of endpoints, including both the response rate and the event time as endpoints. We proposed a Bayesian hierarchical model for the analysis of early phase non-oncology clinical trials with multiple strata and mixed endpoints. The statistical inference and decision-making procedure are illustrated with a hypothetical basket trial for several autoimmune diseases with shared immunological pathways.

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

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