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Activity Number: 153 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Monday, August 8, 2022 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #323276
Title: A Single-Arm Multiple-Stage Bayesian-Frequentist Design with Efficacy and Futility Boundaries
Author(s): Bing Liu* and Jianghua He
Companies: KUMC and University of Kansas Medical Center
Keywords: Phase II Clinical Trials; Multiple-Stage Design; Two-Stage Design; Sample Size Calculation; Binomial Distribution; Bayesian-Frequentist
Abstract:

Simon’s single-arm two-stage design is one of the most popular designs for phase II clinical trials aiming to test the efficacy of a new regimen or treatment. Based on this frequentist design, both Frequentists and Bayesians have been developing new single-arm two-stage designs. Recently, a hybrid approach appeared as a combination of the Bayesian and Frequentist (BF) frameworks for this type of design, where the frequentist type I, type II errors, and other quantities are redefined in a Bayesian way. But there has not been a widely accepted calculation method to derive all necessary quantities under the BF framework. We proposed new design algorithms under the BF framework and extended the 2-stage design to K-stage where K can be greater than 2. Based on the new algorithms, two single-arm multi-stage (SAMS) designs are proposed: the two-stage SAMS design and the extended K-stage SAMS design. The two-stage SAMS design reduces sample sizes needed compared with other two-stage designs; the K-stage SAMS design provides a more flexible design that can potentially reduce the sample sizes further.


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

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