On the use of Minimization Design
*Zhenzhen Xu, CBER/FDA Keywords: Minimization Design; Dynamic Allocation; Randomization; Randomization Test; Cancer Clinical Trials; Minimization design, a dynamic allocation method, is gaining popularity in cancer clinical trials. Aiming to achieve balance on all important prognostic factors simultaneously, this procedure can lead to substantial reduction in covariate imbalance in small clinical trials compared to conventional randomization. While this method generates much excitement, some controversy exists over the proper analysis of such a trial. Traditional Gaussian distribution-based analysis method without considering the dynamic allocation mechanism can lead to invalid inference. Acknowledging this limitation, the ICH E9 Guideline suggests that “The complexity of the logistics and potential impact on analyses be carefully evaluated when considering dynamic allocation”. In this talk, we investigate the proper analysis approaches to inference in a minimization design and evaluate the properties of these approaches under a variety of scenarios with simulation studies.
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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