Abstract #300678

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JSM 2003 Abstract #300678
Activity Number: 135
Type: Luncheons
Date/Time: Monday, August 4, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300678
Title: Adjustment for Covariates in Randomized Clinical Trials: A Regulator's Perspective - THIS LUNCHEON IS SOLD OUT
Author(s): Thomas J. Permutt*+
Companies: Food and Drug Administration
Address: 6424 Fairest Dream Lane, Columbia, MD, 21044,
Keywords: clinical trials ; ANCOVA ; new drug application ; International Conference on Harmonisation
Abstract:

For testing treatment effects in randomized trials, analysis of covariance is robust to most plausible violations of the usual assumptions. Indeed, common "alternatives" to ANCOVA are in fact special cases, with more, not fewer, assumptions. Accordingly, ANCOVA may safely be prespecified as the primary method in trials intended to support new drug applications. Conversely, specification of analysis "as appropriate" may introduce unnecessary, undesirable complications in the regulatory environment. The current state of regulatory guidance (national and international) on adjustment for covariates in drug trials will be critically assessed.

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