Master Protocol Workshop

In contrast to traditional trial designs where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, allowing for efficient and accelerated drug development. Although historically the master protocol concept has been utilized across multiple institutions or sponsors, master protocols are beginning to extend into single company sponsorship; this more discrete setting requires special attention with respect to operational, regulatory, and methodological considerations. This session invites industry experts who have identified and overcome trial complexities associated with simultaneous/concurrent evaluation within a single sponsor setting to share key learnings and best practices. We hope these case studies offer valuable information and support for companies that consider internal development of master protocols.