FDAnews Drug Daily Bulletin


May 31, 2006

The FDA intends to improve supervision of multi-site clinical trials by working on a guidance on the use of coordinators who are not principal investigators (PI), an FDA official has announced.

Scott Gottlieb, deputy commissioner for medical and scientific affairs at the FDA, questioned whether it is "possible, reasonable or appropriate" for a single PI to oversee clinical trials involving 30 to 40 or more sites. He also noted that the FDA is grappling with the question of how to ensure that there is adequate and appropriate supervision in such trials.

In cases where somebody other than the PI performs the primary supervisory role, the FDA wants to develop a mechanism to make that person accountable to the agency, he said May 18 at the 2006 Clinical Research Educational Conference. "We will be asking these questions, and also developing guidance on what we view as adequate supervision by the principal investigator to help address this latter question," he said.

Gottlieb also spoke to the use of technology in clinical trials and the need for the FDA to bring its regulations up to date on this subject. Among other things, he said the agency might do more real-time inspections of clinical trials sites rather than post-hoc audits, while taking advantage of inspections the industry is already doing. The agency will also provide more common standards and regulatory requirements for electronic data handling, as well as clinical research data and data exchange standards to make collaboration easier, he said.