Abstract #301472

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JSM 2003 Abstract #301472
Activity Number: 275
Type: Invited
Date/Time: Tuesday, August 5, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301472
Title: Some Statistical Issues in Bridging Clinical Studies Among Different Populations
Author(s): Stella G. Machado*+
Companies: Food and Drug Administration
Address: 12804 Weiss St., Rockville, MD, 20853-3402,
Keywords: bridging ; pharmacodynamics ; dose response
Abstract:

The ICH-E5 Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data describes the framework for bridging studies to allow extrapolation of foreign clinical data to a new region. The aim is to expedite global development of new drugs and reduce duplication of clinical studies by using bridging studies in the new region to demonstrate that effects are relevant there. These studies may take different forms: pharmacokinetic, pharmacodynamic (PD) or clinical trials of specific endpoints. The central requirement is that a set of clinical studies provides evidence of efficacy and safety of the medicine in the new region. The particular study design will depend on the sensitivity of the drug to ethnic factors, prior experience with drugs of a similar class, and regional differences in medical practice. This talk focuses on a statistical framework as well as methods to achieve these goals. We consider dose response studies as the bridging study, with PD and clinical endpoints for safety and efficacy. Problems complicating the assessment of similarity of treatment action regions are explored, such as differences in the utility of the PD endpoints as surrogate endpoints.

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Revised March 2003