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Abstract Details

Activity Number: 530
Type: Roundtables
Date/Time: Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306219
Title: Evaluation of Sex Differences in Clinical Studies
Author(s): Chul Ahn*+
Companies: FDA/CDRH
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20993, United States
Keywords:
Abstract:

The CDRH draft guidance on sex differences in medical device trials is officially out as of December 19, 2011. In this roundtable we will discuss issues regarding the underrepresentation of women in clinical trials and the recommended statistical analyses of study data for sex differences including strategies of allocating alpha.


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