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Activity Number: 484 - Clinical Trial Design- 5
Type: Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #328988 Presentation
Title: Sample Size Allocation in Multi-Regional Equivalence Studies
Author(s): Jason Liao* and Ziyi Yu and Yulan Li
Companies: Merck & Co. Inc. and Jazz Pharmaceuticals Inc and Myovant Sciences
Keywords: Consistency; Equivalence trial; Multi-regional trial; Sample size allocation

With the increasing globalization of drug development, the multi-regional clinical trial (MRCT) has gained extensive use. The data from MRCTs could be accepted by regulatory authorities across regions and countries as the primary sources of evidence to support global marketing drug approval simultaneously. The MRCT can speed up patient enrollment and drug approval, and it makes the effective therapies available to patients all over the world simultaneously. However, there are many challenges both operationally and scientifically in conducting a drug development globally. One of many important questions to answer for the design of a multi-regional study is how to partition sample size into each individual region. In this paper, two systematic approaches are proposed for the sample size allocation in a multi-regional equivalence trial. A numerical evaluation and a biosimilar trial are used to illustrate the characteristics of the proposed approaches.

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

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