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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 #330007 Presentation
Title: A Confirmatory Basket Trial Design for Multiple Tumor Types Based on Conditional Power
Author(s): Huiling Li* and Jianming Wang and Yeongjin Gwon and Xiaolong Luo
Companies: and Celgene Corporation and University of Connecticut and Celgene Corporation
Keywords: Adaptive Design; Basket Trial; Conditional Power; Phase III; Promising Zone

To simultaneously investigate multiple tumor types in oncology trials, there is rising interest in the statistical design of basket trials to increase efficiency and flexibility. In this kind of basket design, patients with differing histologic tumor types and a common molecular subtype are pooled and investigated in a single trial. We propose a statistical method to enhance the basket trial design in phase III studies using a conditional power approach. Specifically, we prune and select the tumor indications at the interim analysis based on a conditional power threshold which not only allows for different information fraction at the interim across the indications but also accounts for the data accumulated after the interim. We further re-estimate the sample size at the interim for the selected indications using the promising zone method to ensure appropriate power for the final analysis without further adjustment for the nominal type I error rate. We investigate the operating characteristics of the proposed method and also provide an example to illustrate the method.

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

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