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Activity Number: 355 - Contributed Poster Presentations: Biopharmaceutical Section
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #306550
Title: Less Is More – Adaptive Seamless Phase II/III Design
Author(s): Helen Chen* and Jonathan Haddad and Xiaowei Wang
Companies: GSK and GlaxoSmithKline and GlaxoSmithKline
Keywords: Adaptive Design; Treatment Selection; Combination Test

Traditionally, strict frequentist rules (e.g. two independent pivotal trials both with a significant result) have been developed to register a new medical treatment. On the other hand, there is a demand for flexibility to expedite the development process. A seamless (operational and/or inferential) phase II/III design usually contains two stages of traditional clinical trials, a learning stage (phase IIb) for selection and a confirmatory stage (phase III). The integration of two stages into a single trial accelerates the development process of new drugs and all accumulated data can be utilized in the decision process. In this presentation, a seamless inferential phase II/III design was demonstrated with adaptive treatment selection based on combination tests. An optimal sample size was determined with the familywise type I error rate controlled in the strong sense at a targeted power. Extensive simulations were conducted and operating characteristics were shown based on various dose-response models.

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

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