Objective: To report the feedback from global regulatory agencies to Critical Path Institute (C-Path) on the use of digital health technologies (DHTs) for Parkinson’s disease (PD) drug trials with focus on early intervention.
Background: Regulatory agencies recommend consortium-based approaches as a catalyst to advancing DHT-based endpoints for use in clinical trials. C-Path’s Critical Path for Parkinson’s (CPP) Consortium’s 3DT (digital drug development tools) project is a global precompetitive collaboration focused on aligning with regulators. WATCH-PD, a longitudinal observational study focused on early stages of disease, has been used an exemplar study for aligning with regulators in unique ways.
Method: C-Path facilitated meetings with FDA in 2024 and with EMA in 2025 and leveraged their five core competencies to review the totality of evidence to date from the WATCH-PD study at 12 months follow up duration from baseline. C-Path received both informal (FDA) and formal (EMA) feedback.
Results: C-Path presented data-driven evidence to support a digital monitoring biomarker context-of-use for use in clinical trials of disease modifying treatments with phenotypically defined early PD patients. The totality of quantitative and qualitative results of the WATCH-PD study supported gait speed measure as a measure of disease progression. Regulatory feedback focused on the relation between gait speed and other PD motor and nonmotor symptoms, establishing clinical relevance, standardization of DHT assessments, defining paths for interoperability of different device platforms and alignment of findings with other similar DHT initiatives. Both regulatory agencies recommended follow-up of the WATCH-PD participants beyond 12 months.
Conclusion: Early and frequent regulatory feedback and advice have been critical to the success of CPP’s 3DT initiative. Sharing of data and expanded collaborations will inform the field as we search for more objective, precise, and patient-centric measures to enable efficient and meaningful evaluation of future therapies.
To cite this abstract in AMA style:
D. Stephenson, C. Coon, J. Cosman, M. Dockendorf, S. Dolan, J. Edgerton, L. Gaetano, E. Goikoetxea, D. Hill, G. Jones, S. Jorgensen, T. Kangarloo, C. Kopil, G. Lee, J. Mammen, A. Mirelman, C. Ollivier, K. Romero, S. Sardar, Y. Xiao, M. Müller, J. Adams. Advancing the regulatory maturity of digital health technologies with focus on early intervention, Critical Path for Parkinson’s 3DT initiative [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/advancing-the-regulatory-maturity-of-digital-health-technologies-with-focus-on-early-intervention-critical-path-for-parkinsons-3dt-initiative/. Accessed October 5, 2025.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/advancing-the-regulatory-maturity-of-digital-health-technologies-with-focus-on-early-intervention-critical-path-for-parkinsons-3dt-initiative/