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Activity Number: 686
Type: Contributed
Date/Time: Thursday, August 8, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #309474
Title: Stage-Wise Optimal Adaptive Dose Study Design
Author(s): Gang Jia*+
Companies: Merck & Co.
Keywords: Phase II drug studies ; Futility analysis ; Dose studies ; Adaptive Design
Abstract:

Phase II drug studies often show that a drug candidate lacks sufficient efficacy to warrant further Phase III confirmatory trial. Futility analysis enables us to stop the study early and allocate the saved resources to more promising studies. In a multi-dose Phase II trial, futility analysis can be conducted at each dose level so that we can allocate more resources to other promising dose groups. I will propose a stage-wise optimal adaptive design for Phase II dose escalation studies that uses a conservative and flexible design criteria to accommodate different priority on finding the MED and the overall effectiveness. The goal is to achieve the optimal subject allocation with fixed total sample size.


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