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Activity Number: 326
Type: Invited
Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307341
Title: Contribution of Different Design Components to the Efficiency of Response-Adaptive Dose-Ranging Studies
Author(s): Vladimir Dragalin*+
Companies: Aptiv Solutions
Keywords: response-adaptive design ; dose ranging study ; adaptive allocation rule ; stopping rule ; longitudinal model ; simulation
Abstract:

Response-adaptive designs directly address the goals of the learn trials and comprise an integrated approach that efficiently learns about dose-response relationship using a parsimonious working design model. Other important design components are longitudinal models that allow the efficient use of all available information, including information from subjects that have not completed treatment, in learning about efficacy and/or safety, response-adaptive dose allocation to efficiently learn about most important region of dose-response curve or to better estimate the target dose, early stopping rules for efficacy or futility, number of available doses, frequency of the interim analyses, control of accrual rate.

We provide results of a comprehensive simulation study that evaluate the contribution of these design components on the efficiency of such adaptive design in addressing the goals of the adaptive dose ranging studies.


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

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