FDA Invites Meeting Requests for Pilot Program to Spur Trial Innovation

Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests.

The CID pilot meeting program is for innovative designs that require simulations and for which Type 1 errors — false positive findings — may not be acceptable. It’s also meant to boost innovation by allowing the FDA to share trial designs considered in the program, including designs for drugs the agency has not yet approved.

In an Aug. 30 notice, the agency said meeting requests should include key features of the statistical analysis plan, as well as the simulation plan and components of the study design the sponsor believes are non-disclosable.