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Abstract Details

Activity Number: 299
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304854
Title: Regional Treatment Effects in Studies of Cardiorenal Drugs: A Summary of Recent Clinical Trials
Author(s): Steve Bai*+
Companies: FDA
Address: 3148 Dunes Dr, Elliott City, MD, 21042, United States
Keywords: Multi-regional trial ; Meta analysis

Many clinical trials that evaluate cardiovascular treatments intended to impact morbid and/or mortal endpoints enroll patients from centers in multiple countries or geographic regions. In some cases, it may appear that the treatment effect estimated in such trials is not uniform in all countries. To assess whether a discernable pattern exists in the disparity of treatment effects observed among different countries or regions, especially between the US and non-US sites, the data from 24 controlled clinical trials in which it was possible to identify country specific or region specific results, were analyzed alone and combined in a meta-analysis. Based on our analysis of the data from these cardiovascular trials, it appears that there may be systematic differences between the treatment effects observed in the US and non US regions, with the US specific treatment effect usually being smaller than that observed in non US regions. If one of the goals of a study is to demonstrate that there is a positive effect in a specific country such as US, an objective that is usually not currently considered and which may at times be impractical, then it may be appropriate to design the trial

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