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Activity Number: 456
Type: Roundtables
Date/Time: Wednesday, August 3, 2016 : 7:00 AM to 8:15 AM
Sponsor: Biopharmaceutical Section
Abstract #320872
Title: Assessing Safety of Rare Events for Sparse, Limited, or Extreme Data
Author(s): Mike Wright Colopy*
Companies: UCB Bioscience
Keywords:
Abstract:

Rare safety events are difficult to evaluate in cases where sample sizes are small, studies have zero events in treatment arms, and meta-analytic methods vary. In this roundtable discussion, we will identify the shortcomings of standard statistical techniques, pros & cons of more advanced techniques, how well companies are prepared for unexpected rare safety signals, and how statisticians can communicate the risks to nonstatisticians.


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

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