FDA, NIH Propose Protocol Template for Phase 2 and 3 IDE Studies

With an eye toward making the conduct of clinical studies more efficient, the FDA and NIH have unveiled a template intended for investigators writing Phase 2 or 3 trial protocols that require IDE applications.

According to the agencies, the template aims to help investigators prepare protocols that are consistently organized and contain all of the information needed for proper review of trials. The proposed template follows the standard outlined in the International Conference on Harmonisation Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH:E6).

“We see the template as a way to facilitate creativity and innovation, not inhibit it,” CBER Director Peter Marks said.

“Just as ICH E6 allows considerable flexibility in the actual operations of trials using quality by design principles, the template includes the appropriate elements to be considered, but does not dictate exactly how the trial should be done — that is the work of the investigators,” he adds.

Comments are due by April 17. Access the draft template here: www.fdanews.com/04-06-16-INDIDE.pdf.