In its effort to ramp up the use of complex innovative designs (CID) in late-stage research, the FDA has published three study designs it considers novel.

Through its CID Pilot Meeting Program, the FDA has issued case studies on a proposed master protocol to study chronic pain, a proposed systemic lupus study that uses an adaptive rule to consider changing the primary endpoint 52 weeks into the study and a proposed diffuse B-cell lymphoma trial that uses external control data.

The program is designed to advance the use of complex adaptive, Bayesian and other novel designs. Sponsors that participate in the program will be able to interact more closely with agency staff on their proposed innovative designs. The agency has set four requirements for participating in the pilot study, which continues through 2022:

• The sponsor must have an IND or pre-IND number for the medical product in the CID proposal;
• The proposed CID must intend to gather substantial evidence of effectiveness to support regulatory approval;
• The trial cannot be a first-in-human study and there must be an adequate amount of clinical information to inform the proposed CID; and
• The sponsor and agency must be able to agree on trial design information to be shared publicly.

Read the case studies here: https://bit.ly/3Kj3Boe.