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187 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Monday, July 31, 2017 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #322925
Title: FDA Draft Guidance on Multiple Endpoints
Author(s): Kate Liu*
Companies: Amgen, Inc.
Keywords: Multiple Endpoints ; FDA Guidance
Abstract:

In January 2017, FDA released a draft of Guidance for Industry on Multiple Endpoints. This draft guidance, when finalized, will provide greater detail than ICH E9 on strategies to avoid false conclusions. Since most clinical trials performed in drug development contain multiple endpoints, we would like to invite you to share your thoughts/experience on the range of topics covered in this critical draft guidance.


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

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