FDA to Strengthen Clinical Trials Oversight 4144

BUSINESS NEWS

At the end of June, FDA announced a series of new policy and regulatory developments intended to strengthen the agency's oversight and protection of patients in clinical trials, and the integrity of resulting data. Experts in the field agree that the agency's initiative will have a significant impact on the ways that medical device manufacturers conduct clinical trials—but the full implications of the initiative are far from clear.

Launched as part of FDA's Critical Path Initiative, the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative is expected to help the agency modernize its approach to bioresearch monitoring. The HSP/ BIMO steering committee will be chaired by FDA deputy commissioner for operations Janet Woodcock, MD.

"As clinical trials continue to evolve, in particular becoming increasingly large, decentralized, and global, FDA's approach to bioresearch monitoring and human subject protection must also evolve and modernize," Woodcock said.

Woodcock also said that the new initiative would enable FDA to make the most of its resources to ensure the safe conduct of clinical trials.

But precisely how the agency intends to change its monitoring of medical device trials is unclear—especially in light of the makeup of the HSP/BIMO committee. "The most striking thing about this is that nobody on the steering committee represents the Center for Devices and Radiological Health," says Helen Colquhoun, MD, president and CEO of Pleiad Inc. (Cambridge, MA), a clinical research organization (CRO) specializing in medical devices.

"There are going to be more inspections of trial sites, sponsor offices, and clinical research organizations. This should be of particular concern to medical device manufacturing executives because many companies still do not fully comply with the investigational device exemption regulations that govern clinical trials," Colquhoun says.