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Activity Number: 75
Type: Contributed
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307222
Title: Issues of Covariate Adjustments in Clinical Trials
Author(s): Moh-Jee Ng*+ and Tie-Hua Ng
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 10903 New Hampshire Ave., Silver Spring, MD, 20993,
Keywords: covariate adjustments ; clinical trials
Abstract:

Baseline covariate adjustments are often made in the analyses of randomized controlled trials. However, the results with adjustments for covariates that are measured not at baseline but after randomization could be misleading because such covariates may be affected by the treatments. Therefore, such results must be viewed with caution. Examples will be presented for illustration purposes.


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