Given that clinical trials are conducted globally, couldn't they be regulated in the same manner? That's what the FDA and the European Medicines Agency (EMEA) will explore this fall. The two agencies have just announced they will collaborate for 18 months on a new bilateral good clinical practices (GCP) pilot project.

Leslie Ball, director of the Division of Scientific Investigations (DSI) within FDA's Center for Drug Evaluation and Research (CDER), explained that the initiative will focus on collaborative efforts to inspect trial sites with a single team comprised of FDA and EMEA representatives. Those should start fast—on Sept. 1.

She says she believes the effort will be welcomed by sponsors doing research in both the U.S. and Europe. ““Each of the agencies have been contacted separately by sponsors who complained that they submitted an application to both regulatory authorities. One month, the FDA would show up to conduct an inspection, and a month later EMEA would show up and do same thing,” or the other way around, says Ball. She adds that inspections to validate data and ensure safety for trial subjects can take up to a week per site, so the duplicated efforts are slowing down the studies.

A Single Burden

Besides dual site inspections, other objectives of the FDA-EMEA GCP initiative include: streamlining the sharing of GCP inspection planning information; communicating on inspection outcomes; sharing inspection procedures and best-practice knowledge; keeping each agency updated on new GCP-related legislation, regulatory guidance and related documents; and sharing interpretations of GCP that may differ among the two agencies.

“On both sides of Atlantic, we operate on ICH-GPP E6 (International Conference on Harmonisation 's Guideline for Good Clinical Practice [referred to as E6]) principles—why not share information and be more efficient about what we do, and potentially decrease the regulatory burden for sponsors?” Ball asks.

Given that both regulatory bodies operate under the same international-standard charter, Ball says most of each agency's agenda is identical. “The ICH E6 has very broad outlines, but we (the FDA and the EMEA) think about GCP in the same way.”

Still, the collaboration will only go so far. When it gets down to the fine print of regulations in Europe and the U.S., if a potential violation arises, each regulatory body will handle it separately.

“There is the understanding that we are separate regulatory bodies,” Ball explains. “Our regulations are different, and the statutory basis is different. So if we uncover problems with data integrity or human-subject protection, while we may have the same general approach with regard to violations, each regulatory authority will have to consider their own regulations to determine the specific follow-up that would be needed.” That leads to another of the initiative's intentions: “To figure out which areas are different and consider the areas in which we may harmonize in the future,” Ball adds.

Distant Future

Might new regulations or guidance come out of the pilot project? Yes, says Ball. But it's premature to speculate on the nature of such rules, as they could only emerge at a some highly indefinite date in the future.

How did the effort originate? In 2003, the EMEA and FDA signed a collaboration agreement to share more regulatory information, which sounded promising. “It did mention GCP inspection information, but there wasn't any formal collaboration agreement,” says Ball. “And that wasn't particularly effective on either end.”

Then last fall, another pilot project on good manufacturing practices (GMP) came together between the FDA, EMEA and Australia. Watching it, the regulatory folks who focus on GCP became inspired.

“After that was kicked off with the EMEA, there was a recognition that there would be benefit to expanding it to GCP,” Ball says. So late last year, the EMEA and the FDA started hammering out the specifics of such a collaboration, establishing links and having monthly conference calls.

Come Forth

At this point, says Ball, the EMEA and FDA are asking sponsors to voluntarily identify new drug applications for which trials are being planned in both Europe and the U.S. Those sites are eligible for joint inspections under the new pilot program.

In addition, the EMEA and FDA will begin sharing information on studies that are ongoing. “We intend to share as much information as can legally be exchanged on inspections that are currently being conducted,” says Ball, adding that the monthly conference calls will continue, perhaps becoming more frequent. The two bodies are also sharing information electronically.

At the end of the 18 months, the FDA and the EMEA will review the effort and change the process as needed. The pilot project will initially apply only to drugs, but could be expanded to include medical devices and dietary supplements later.

by Suz Redfearn

d9A2t49mkex