Stop Clinical Trial Advantages in Foreign Countries: Editorial

Writing in an Annals of Pharmacotherapy editorial, University of Connecticut professor C. Michael White says FDA should act to eliminate the differing rules for completing INDs, different inspection rates, and different inspection intensities that advantage foreign clinical trial sites. “It is a threat to U.S. competitiveness and the quality of data that is being produced,” White writes. “FDA needs a larger federal appropriation to conduct inspections of foreign clinical sites.”

White says the current system raises the potential that sponsors will conduct trials in foreign countries that would never be accepted in developed countries and needlessly harm patients. “If we cannot morally approve of a study among our citizens, we need to protect those in other countries as well,” he writes.

According to the article, there are data quality and ethical issues raised in clinical trials in developing countries.