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Activity Number: 144
Type: Invited
Date/Time: Monday, August 1, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #318236 View Presentation
Title: Some Observations on De Jure Estimation
Author(s): Thomas Permutt*
Companies: FDA
Keywords: de jure ; efficacy ; missing data ; dropout ; confounding ; Simpson's paradox
Abstract:

In drug trials there may be interest in estimating the hypothetical effect of the drug under conditions of perfect adherence. Those are conditions, of course, which did not obtain in the trial itself. Care is required, but often lacking, in explaining what the hypothetical conditions are. I will discuss several versions of the alternate universe in which adherence was perfect. The effects of the drug may be different in these different universes, so that no single estimator can consistently estimate all of them. Furthermore, estimators commonly claimed to estimate de jure effects do not consistently estimate any of them.


Authors who are presenting talks have a * after their name.

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