As more companies outsource expensive human clinical trials to lower-cost foreign sites, the FDA says it is confronting “huge” challenges in the safety and effectiveness of data that come back to the US for review.
These problems run the gamut from ethical and medical practice standards to site-inspection travel costs to reading case reports in unfamiliar languages.
“The challenges are huge, and they include issues related to human subject protection, making sure that the standards that we expect trials to be conducted under are adhered to in countries that were less often used for clinical trials in the past,” according to the FDA’s director of new drugs, John Jenkins.
Addressing a Drug Information Association “town meeting” in Philadelphia on June 22, Jenkins said the trend has also caused FDA to worry about the validity of data gathered among foreign populations data when extrapolated to the US population.
FDA associate director for medical policy Robert Temple offered that the trend is making FDA “nervous” because of patient “subset” differences in drug responses between ethnicities and different cultures that can emerge. “They may or may not be real,” he said, “but when a study from Serbia drives the whole study, I have to tell you it provokes some nervousness.”
Temple said that US clinical trial investigators can be barred from further service, or even jailed. “So we think it’s not a bad idea to have clearly US data most of the time.”
From the August 01, 2006 Issue of MM+M - Medical Marketing and Media
