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Activity Number: 254
Type: Contributed
Date/Time: Monday, August 1, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #320898
Title: Optimal Borrowing of Historical Control Data in Clinical Trials
Author(s): Saurabh Mukhopadhyay* and Qi Tang and Alan Hartford
Companies: AbbVie and AbbVie and AbbVie
Keywords: historical data ; clinical trials
Abstract:

Many clinical trials involve placebo or active control arm for which similar clinical data already exists from historical studies. Due to various considerations it is often very appealing to leverage such historical data in the control arm. We plan to present a novel way of borrowing the information while attaining a desired power level and maintaining the stipulated type I error rate. A few variations of models and decision rules are considered to study their relative merits in a specific application.


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

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