FDA Report Card 2015: Handling of OUS Data

Handling of Data from Clinical Trials Conducted Outside the United States

Thinking of clinical trials in terms of geography (i.e., US vs. OUS) is antiquated thinking. If a clinical trial is designed, conducted, and analyzed properly, it should not matter what part of the globe it is conducted on. Both FDA and industry should remember this.

—Michael Drues, PhD, president, Vascular Sciences

Based on prior experiences and general knowledge, I expect that it will improve.

—Larry R. Pilot, attorney at law

FDA is moving in the right direction toward the use of OUS clinical data. This is essential in a global market for medical technology.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green