TL5: Strategies to Mitigate Against Operational Bias in Adaptive Designs
*Greg Maislin, Biomedical Statistical Consulting Keywords: adaptive design, operational bias The potential for improving clinical trial efficiency through adaptive design is widely recognized. There are a number of approaches to incorporating adaptive features that use data collected during the conduct of the study to modify or refine the design prior to its completion. These include group sequential methods, sample size re-estimation methods, and Bayesian adaptive design methods. If the data used in such adaptations involve unblinded determinations of effect size, there is concern that the process of implementing adaptive design elements may make information available to clinical trial staff that lead to behavioral changes. These behavioral changes can influence the conduct of the trial resulting in "operational bias" when estimating treatment effects and testing hypotheses. This roundtable session will address the following questions, "What strategies exist for reducing operational bias without introducing prohibitive operational complexity? Do such strategies differ between medical device trials involving unblinded treatments compared to double-blind clinical trials of pharmaceuticals?
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC