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

Abstract Details

Activity Number: 555
Type: Invited
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: General Methodology
Abstract - #305964
Title: Statistical Testing in Clinical Trial with Covariate Adaptive Randomization
Author(s): H.M. James Hung*+ and Sue-Jane Wang
Companies: FDA and FDA
Address: 10903 New Hampshire Avenue, Bldg 22 Room 4238, Silver Spring, MD, 20993-0002,
Keywords: baseline covariates ; imbalance ; drug development
Abstract:

Randomization is an essential tool to yield balance on observed and unobserved baseline covariates between the treatment groups to compare. When the sample size is not large, there may be apparent imbalances on some covariates even under complete randomization. Literature provides a number of covariate adaptive randomization methods such as the method of Pocock and Simon for minimizing the occurrence of such undesirable apparent imbalances. Under this type of randomization, valid statistical tests become an issue of discussion in literature. In this presentation, we shall share our regulatory review experiences from different phases of drug development.


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