Adaptive Patient Population Selection Design in Clinical Trials
View Presentation *Hui Quan, Sanofi-Aventis Dongli Zhou, Sanofi-Aventis Pierre Mancini, Sanofi-Aventis Philip He, Sanofi-Aventis Keywords: conditional power, sample size re-estimation, closed testing procedure, weighted combination test, trial simulation. For the success of a new drug development, it is crucial to select the sensitive patient populations. To potentially reduce timeline and cost, we may apply an adaptive patient population selection design to a therapeutic trial. In such a design, based on early results of the trial, patient population(s) will be selected/determined for the final stage and analysis. Because of this adaptive nature and the multiple between-treatment comparisons for multiple populations, alpha adjustment must be performed. In this paper, we propose a closed testing procedure for assessing treatment effects for multiple populations and a weighted combination test for sample size and population adaptations. Computation/simulation is used to compare the performances of the proposed method and other multiplicity adjustment methods. A trial example is presented to illustrate the applications of the methods.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC