Objective: To develop a framework of protocol-aligned rater training, educational resources, and inter-site engagement (Stage 1). The secondary aim was to assess the perceived usefulness of these resources among site staff (Stage 2).

Background: The Edmond J. Safra Accelerating Clinical Trials in Parkinson’s Disease (EJS ACT-PD) is the UK’s first multi-arm, multi-stage platform trial, testing multiple potential disease modifying treatments in parallel across >40 centres. While increasing the trial’s scope and scale improves efficiency and population representativeness, it requires measures to minimise inter-rater variability, eliminate inconsistent data collection practices, and ensure familiarity with the disease and protocol complexity.

Method: Stage 1 involved iterative development of educational, training and operational resources to standardise trial delivery. These were informed by experienced trial practitioners, neurologists, trial managers, researchers, and PPIE contributors. A national network of trial practitioners was established to support inter-site engagement and ensure consistent implementation of the protocol beyond site initiation visits. Stage 2 comprised an online survey to assess site staff confidence and resource usability/engagement.

Results: Resources were produced to support the understanding of PD (symptoms, treatment/complications, practical considerations for study visits) and real-world administration of rating scales: (1) Mandatory PD Awareness Training; (2) Parkinson’s Medication Guide; (3) Assessment Guide; (4) Guidance for Remote Appointments. Recruitment processes were standardised and aligned with our EDI goals: (1) Guidance for Pre-screening Telephone Calls; (2) Recruitment and Retention Guide. The national network remains active across all open sites and meets monthly under defined terms of reference. It facilitates dissemination of best practices and discussion of optimal local recruitment strategies. Evaluation of survey data assessing perceived usefulness of these resources is underway.

Conclusion: A structured, PPIE-informed framework, based on real-world translation that is meaningful to participants, was developed to support the delivery of EJS ACT-PD. By combining educational materials with network-based collaboration, this approach aims to reduce inter-rater variability, strengthen recruitment/retention, and enhance data integrity.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/demystifying-the-delivery-of-multi-arm-multi-stage-platform-trials-for-parkinsons-disease-framework-and-recommendations-from-ejs-act-pd/