Findings
Current PD endpoints, such as UPDRS and PDQ scales, rely on subjective assessments and may not fully capture disease fluctuations or treatment effects.
Accelerometer technology offers objective and continuous data, addressing limitations of traditional endpoints.
The proposed endpoint focuses on “bothersome tremor,” validated through observational studies and patient input.
Collaboration among stakeholders, including regulators and technology manufacturers, is crucial for endpoint development and standardization.
Developing a basket of endpoints, including accelerometer-derived measures, can provide a more comprehensive picture of PD burden and treatment impact.

Recommendations
Define the context of use (COU) for accelerometer-derived endpoints, focusing on patient-centered measures like “number of episodes and total duration of bothersome tremor.”
Validate accelerometer data through real-world and controlled studies, correlating it with existing PD measures and clinical outcomes.
Collaborate with technology manufacturers to optimize accelerometer placement, signal detection, and patient usability.
Engage with regulators early to align novel endpoints with evidentiary and regulatory requirements.
Establish frameworks for data sharing and standardization to facilitate endpoint development and adoption.

Regulatory Considerations
Validate endpoints to ensure alignment with existing PD measures and regulatory standards for clinical trials.
Incorporate patient feedback during endpoint development to support meaningful and relevant measures.
Address intellectual property (IP) concerns by redefining IP as the execution of algorithms rather than the algorithms themselves.
Align trial design with regulatory requirements, ensuring endpoints can reliably measure treatment impact on PD symptoms.
Engage regulators early to obtain feedback and confirm endpoint readiness for regulatory submission.