This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 301
Type: Contributed
Date/Time: Tuesday, August 3, 2010 : 8:30 AM to 10:20 AM
Sponsor: IMS
Abstract - #307115
Title: Estimation of Treatment Effect Following a Clinical Trial with Adaptive Design
Author(s): Xiaolong Luo*+ and Peter Ouyang
Companies: Celgene Corporation and Celgene Corporation
Address: , , 07901,
Keywords: Clinical Trial ; Adaptive Design ; Marked Point Process ; Treatment Selection ; Martingales ; Stochastic Calculus

In this paper, we introduce a new framework based on marked point process (MPP) to model clinical trial data flow in which the calendar time based process of the trial conduct and any modification of the study design including sample size, treatment plan, and/or study endpoints will be retained. This MPP model allow us to use methods of stochastic calculus for analyses of any adaptive trial data. As an example, we apply this method to a two stage drop-the-loser design and extend the work by Sampson and Sill (2005, 2008), Stallard and Friede (2008), Li, Wang, and Ouyang (2009) and others to non-parametric case. Furthermore, we derive a new procedure for the estimation of the treatment effect and complement results on the hypothesis testing that have been the primary focus in the recent literature. Numerical examples will be used to illustrate the performance of the procedure.

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