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Activity Number: 326 - Use of Concurrent and Non-Concurrent Control Data in Basket and Platform Trials
Type: Topic Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #304500
Title: Use of Historical Control Information in Platform Trials
Author(s): Satrajit Roychoudhury*
Companies: Pfizer Inc
Keywords: Platform Trial; Historical Control ; Bayesian Hierarchical Model

Latest version of the Prescription Drug User Fee Act (PDUFA VI) encourages the use of complex and innovative trial design that helps efficient and informative decision making in drug development. Platform trials have a potential to explore multiple new therapies or new disease areas in a single clinical trial. It provides statistical efficiencies including borrowing information from similar disease, use of historical control data and adaptive randomization to accelerate the drug development process. This talk will focus on the statistical methodology and application involving the use of historical control information in platform trial. Use of historical control information allows effective trial design including smaller sample size. Bayesian approach allows a natural way of incorporation of historical data into the statistical analysis as "prior". Use of historical control data in platform trial is challenging due to the presence of both “non-contemporaneous” and “contemporaneous” control information. A meta-analytic approach to combine both types of control information will be presented. Simulation studies and a real life example will be used for illustration.

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

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