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Activity Number: 331 - ASA Biopharmaceutical Section Student Paper Award Competition
Type: Contributed
Date/Time: Tuesday, August 9, 2022 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #322688
Title: BOB: Bayesian Optimal Design for Biosimilar Trials with Co-Primary Endpoints
Author(s): Xiaohan Chi* and Zhangsheng Yu and Ruitao Lin
Companies: Shanghai Jiao Tong University and Shanghai Jiao Tong University and MD Anderson
Keywords: Bayesian optimal design; Biosimilar; Co-primary endpoints; Power; Sequential design
Abstract:

For regulatory approval of a biosimilar product, extensive evaluations should be performed by clinical trials to establish similarity between the reference product and proposed biosimilar in terms of efficacy and safety. Existing biosimilar designs often use a single primary efficacy endpoint in trial monitoring and separately evaluate the safety of the biosimilar product in a secondary analysis. However, ignoring safety and the correlation between safety and efficacy in trial monitoring may lead to a high false positive rate or delay the termination of the trial when dissimilarity in safety is early detected. We propose a Bayesian optimal design for biosimilar trials by incorporating both safety and efficacy endpoints in a uniform framework. Based on a Bayesian joint safety and efficacy model, we sequentially use a so-called Bayesian biosimilar probability to make go/no-go decisions. We calibrate the Bayesian design to maximize the statistical power while maintaining the frequentist type I error rate at the nominal level. We carry out extensive simulation studies to show that the design has desirable performance in terms of the false positive rate and the average sample size.


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

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