Keywords: Alzheimer's disease, scientific working group, statisticians led, methodology
The Alzheimer’s Disease Scientific Working Group (AD SWG) led by statisticians from industry, academic, and government sectors has been formed to promote the advancement of AD treatments. The focus of this SWG is research collaboration aimed at developing and promoting analytical approaches in relevant areas of AD, with the primary goals of advancing the understanding of the disease and enabling the next generation of breakthrough treatments. In particular, the AD SWG strives to:
• Assume a statistical leadership role in advancing the AD field in the areas of research and drug development; • Form a broad-based AD Statistics Community that will stay current, connected and collaborative; • Reach out to other AD research groups to establish linkage and potential collaboration; and • Deliver presentations and develop workshops at statistical and/or medical conferences
Currently the AD SWG consists of a core group that has representation from 10 pharmaceutical companies as well as academia and regulators. The working group has identified a list of topics that are pressing and critical in the AD field and efforts are underway to address these challenges, including, for example, considerations for estimands/primary analysis and how to demonstrate disease modifying effect. During this roundtable, we will share with the participants the progress that the SWG has made and discuss future activities.
Hong Liu-Seifert Eli Lilly and Company
Steve Wilson FDA