FDA pilot to promote clinical trial innovation

FDA announced Wednesday the establishment of the Complex Innovative Designs Pilot Meeting Program. The program is intended to help individual companies overcome barriers to employing innovative trial designs, and in the process create public case studies that can inform industry.

FDA has championed the use of adaptive, Bayesian and other novel clinical trial designs for years, but uptake from drug developers has been limited. Part of the reluctance to adopt new clinical trial designs is uncertainty about how broad ideas can be implemented for specific drug development programs...