All Times EDT
Keywords: Advisory Committee Meetings, roles of statisticians
FDA Advisory Committee Meetings are crucial moments in the FDA approval process for drugs and devices. At these public hearings, independent panels of experts are tasked with providing guidance to FDA, such as whether a specific therapy should be approved. There are four distinct and important roles that statisticians in the play in the preparations and conduct of these meetings. The FDA statistical reviewers, the committee’s statisticians, the sponsor company’s statisticians, and external statistical experts invited by the sponsor, each contribute to the committee’s understanding and can be the key to a product approval or rejection. In this session, we’ll discuss the importance of FDA AdComs, the roles of each of these statisticians, and how sponsor teams prepare for these meetings.