White Paper: Foreign Clinical Trial Data

Given the high cost of moving a promising drug candidate through years of clinical trials, it's no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and "fast-track" approval programs such as 505(b)(2).

A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method gains approval for reformulations and new routes of administration in a fraction of the time required by traditional paths. For drug development companies using the accelerated approval of the 505(b)(2) pathway, filling and completing trials quickly offers both a competitive and a cost advantage.

In 2008, 80% of marketing applications for drugs and biologics approved by the U.S. Food and Drug Administration (FDA) included at least some data from foreign clinical trials, and it is estimated that 40% to 65% of all trials are conducted outside the United States.

Why Foreign Data Acceptance is Increasing:

• The desire to reduce the cost of drug development
• The need to accelerate the approval of safe and effective drugs
• The increasing ethnic diversity of the U.S. population
• The ability to determine a medication's safety, efficacy and metabolism across ethnicities
• Expanding medical knowledge allowing the characterization of ethnic factor influence on a given drug

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