Abstract #301048

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JSM 2003 Abstract #301048
Activity Number: 275
Type: Invited
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301048
Title: Statistical Methods for Bridging Foreign Data to a New Region
Author(s): Somnath Sarkar*+ and Hiroyuki Uesaka and Chuck Rivera
Companies: Eli Lilly & Company and Eli Lilly & Company
Address: 10053 Whitney Way, Fishers, IN, 46038-8386,
Keywords: bridging ; ICH guideline ; matched case-control ; clinical trial
Abstract:

Utilizing foreign clinical data from a large-scale trial to draw conclusions about the safety and efficacy of a drug in a new region will avoid having to repeat a trial of such magnitude in the new region. This approach is not only cost-effective, it expedites the approval of valuable new drugs, so patients in the new region can sooner benefit from new therapies that are currently helping millions of people worldwide. The ICH guideline (ICH Harmonized Tripartite Guideline: Ethnic Factors in the acceptability of foreign clinical data) indicated that a bridging study could be performed in the new region proving efficacy, safety, dosage, etc., and would allow subsequent extrapolation of foreign clinical data to the population in the new region. From this definition, however, the statistical methods that could be used for the purpose of bridging data between two populations is not clear. Statistical methods such as matched case control methodology and distribution-matching methodology can be used as statistical tool for "bridging." This presentation will describe such methods for bridging foreign data to a local population with examples from clinical trials.

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