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.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.