Planning for Prevention of Parkinson's Disease: a trial design forum

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Project summary/ abstract: The proposed conference, “Planning for Parkinson’s Prevention: A trial design forum” will be held May 5th to 7th, 2024, and as a biannual series recurring in 2026 and 2028. The overall aim of this educational program is to facilitate the rational design and timely implementation of the first clinical trials for the prevention of Parkinson’s disease (PD). It will be pursued through six specific aims (SAs): SA #1 is to educate attendees on the critical design elements for PD prevention trials via symposium sessions. SA #2 is to gain regulatory perspective on how the selection of outcomes and other design features may be informed by evolving, biomarker-based disease staging systems, and how these design features may support a pre-diagnostic therapeutic indication. SA #3 is to foster partnership and collaboration within the emerging community of stakeholders in PD prevention, including the unique, newly developing advocacy constituency of people at substantially increased risk of PD based on their genetic or prodromal features. SA #4 is to facilitate pre-competitive knowledge exchange and collaboration among researchers developing the first prevention trials by inviting presentations and panel discussions of their early protocols. SA #5 is to enhance diversity among trainees, investigators, and subsequently trial participants, via targeted outreach to underrepresented groups in medicine. SA #6 is to ensure enduring and wide access to the knowledge and insights gained at the meetings through their peer-reviewed, open-access publication. The conference series will engage, educate, and motivate a diverse collaborative community of prevention stakeholders to accelerate development of rigorously designed early trials for PD prevention, thereby enhancing prospects for their success.