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Activity Number: 469 - Novel Trial Designs in Precision Medicine
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329845
Title: A Case Study of Adaptive Seamless Design with Subpopulation Selection in Oncology
Author(s): Rui Qin*
Companies: Janssen Pharmaceutical R&D
Keywords: subgroup analysis; predictive biomarker; adaptive design; precision medicine

Efficacy of many novel therapies in oncology might be restricted to a subset of patient population. Predictive biomarker(s) have been co-developed with novel therapies to achieve precision medicine. Adaptive seamless design with subpopulation selection has been recently proposed to conduct interim analysis for selection and/or enrichment of patient population and combined phase II and phase III data for final analysis of efficacy. However, the application of adaptive seamless design in phase II/III oncology trials must face a few challenges: choice of interim endpoint, decision rule for subpopulation selection, performance criteria for design evaluation and so on.

We will demonstrate a case study of adaptive seamless design with subpopulation selection in a phase II/III oncology trial through a retrospective real example, and present accompanying simulation studies to evaluate its operating characteristics through working through those challenges.

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

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