Abstract #302053

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JSM 2002 Abstract #302053
Activity Number: 231
Type: Luncheons
Date/Time: Tuesday, August 13, 2002 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #302053
Title: Global Bridging Strategies: Issues in and Approaches to Implementing ICH-E5
Author(s): Scott Patterson*+
Affiliation(s): GlaxoSmithKline, Inc.
Address: 1250 S. Collegeville Rd, UP4205, Collegeville, Pennsylvania, 19426, USA
Keywords:
Abstract:

ICH-E5 (1998), entitled "Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data," has opened the door to the use of clinical trials data from one region of the world in support of market access in other regions. While the opportunity offered by ICH-E5 is clear, the details of the implementation for the bridging strategy are in development, and statisticians play a key role in this process. We will discuss strategic bridging approaches to global drug development and possible statistical methodologies to address the questions of interest.

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Revised March 2002