Category: Parkinson’s Disease: Clinical Trials
Objective: To consolidate current opinion on trial methodology of disease modifying therapies (DMTs) for Parkinson’s disease (PD) and establish consensus on a core protocol for an adaptive platform trial.
Background: Current neuroprotective trial delivery in PD is slow and inefficient. An adaptive trial platform may offer benefits but requires consensus on a core protocol [1]. In collaboration with The Cure Parkinson’s Trust, a Delphi study is being conducted with a broad range of international stakeholders to seek opinion on aspects of trial design for neuroprotective trials in PD.
Method: Clinicians, industry and funding agency representatives as well as People with Parkinson’s (PwP) and their care partners are invited to take part. In order to ensure the process comprehensively addresses issues important to all involved stakeholders, participants are encouraged to suggest topics for inclusion in the Delphi process as part of the first survey. Participants are asked to rate the importance of trial design aspects on a 9-point semantic differential scale and are encouraged to give reasons for their choices. After being presented with a representation of group scores and feedback, participants are asked to re-rate. This process is repeated 4 times or until 70% of at least 3 participant groups score within the same 3 point range.
Results: This process will result in the identification of aspects important to stakeholders in neuroprotective trials of PD. The information will be made available to working groups dedicated to the design and initiation of an adaptive platform trial for disease modifying therapies in PD.
Conclusion: We are seeking opinion from international stakeholders and experts in neuroprotective trials on important aspects of trial design. This is the first step towards the development of an internationally endorsed protocol for an adaptive trial platform in PD.
References: Zeissler M, Li V, Parmar MKB, Carroll CB. Is it possible to conduct a Multi-Arm Multi-Stage Platform trial in Parkinson’s disease: lessons learned from other neurodegenerative disorders and cancer. Journal of Parkinson’s disease 2020, In press
To cite this abstract in AMA style:
M. Zeissler, R. Windle, K. McFarthing, K. Raphael, G. Rafaloff, C. Carroll. Using a Delphi process to inform the design of disease modifying trials in Parkinson’s disease [abstract]. Mov Disord. 2020; 35 (suppl 1). https://www.mdsabstracts.org/abstract/using-a-delphi-process-to-inform-the-design-of-disease-modifying-trials-in-parkinsons-disease/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2020
MDS Abstracts - https://www.mdsabstracts.org/abstract/using-a-delphi-process-to-inform-the-design-of-disease-modifying-trials-in-parkinsons-disease/