Master Protocols and Complex Innovative Design

Complex innovative designs (CIDs) for clinical trials provide sponsors the opportunity to design and implement more efficient trials that can enhance and potentially expedite the drug development process compared to conventional designs, thereby bringing new medicines to patients sooner. The U.S. Food and Drug Administration demonstrated its encouragement for such clinical trial innovations through the creation of the CID Pilot Meeting Program; the purpose of the pilot is to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The pilot, agreed to as a performance goal under PDUFA VI, gives sponsors whose meeting requests are granted by the Agency an important opportunity to have increased interaction with FDA staff to discuss their proposed CID approaches. Since its introduction, many sponsors have interacted with FDA through this program to gain alignment on their proposed novel CIDs. This session will provide attendees with an overview of the FDA CID Pilot Meeting Program and feature discussion of specific case examples. Recent advances in novel design concepts will also be discussed.