Considerations In Using Foreign Trial Data In U.S. NDA Submissions

By Ken Phelps, Camargo Pharmaceutical Services

More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. Foreign clinical trials also address the increasing ethnic diversity of the U.S. population, establishing a medication’s safety, efficacy and metabolism across various ethnicities.

According to a report on the PharmaTimes Online website, 80 percent of marketing applications for drugs and biologics approved by the Food and Drug Administration (FDA) included at least some data from foreign clinical trials in 2008, and it is estimated that 40-65 percent of all trials today are conducted outside the United States.

While the lower costs and shorter recruiting times is obviously appealing to all drug developers, it’s especially attractive to those involved in generic and fast-track approval programs such as 505(b)(2). However, to be successful in pursuing this pathway, it’s important to choose a research partner with expertise in identifying the data least likely to raise a red flag for the FDA and to address these considerations in advance.