All Times EDT
Keywords: estimand, Alzheimer, Advisory Committee
The conversation about estimands has moved into implementation across the industry. Statistician and their clinical colleagues are sorting through the various disease areas and study designs to create precise definitions of estimands that are clinically meaningful and acceptable to regulatory agencies. This session will feature an enactment of meetings between industry statisticians and clinicians with their regulatory counterparts. A hypothetical Alzheimer’s Disease treatment will be the focus of the discussion. The session will consist of three parts. The first part will portray an End of Phase 2 Meeting between the industry and regulatory participants. In this part of the session, the industry Sponsor will present its rationale for its Phase 3 trial estimands. Regulators will challenge and advise the Sponsor. The second part of the session will be after the hypothetical trial is complete and the Sponsor will share results with regulators in a Pre-NDA meeting. There will be challenges and debates. The third part of the session will be a floor discussion and Q&A from the audience. The hypothetical study and results will be constructed to maximize the opportunity for different perspectives and approaches. Both statistical and clinical viewpoints will be incorporated. Rather than a series of formal presentations and a discussant, ideas and proposals will be presented by the Sponsor, and regulators will share their perspectives in the context of the regulatory interactions. At the end of the session, the audience will be asked to vote (as if they were an Advisory Committee) on whether to approve the treatment or not.