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Abstract Details

Activity Number: 650
Type: Topic Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304722
Title: Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials
Author(s): Nelson Lu*+ and Rajesh Nair and Yunling Xu
Companies: FDA and FDA and FDA
Address: 10903 New Hampshire Ave., Silver Spring, MD, , USA
Keywords: Multiregional clinical trial ; Decision rule ; Sample size planning

Multiregional clinical trials provide the potential to make safe and effective medical products simultaneously available to patients globally. As regulatory decisions are always made in a local context, this poses huge regulatory challenges. In this paper we propose two conditional decision rules which can be used for medical product approval by local regulatory agencies based on the results of a multiregional clinical trial. We also illustrate sample size planning for such trials.

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