Parkinson's disease is a progressive neurodegenerative disorder that significantly impacts patients' mobility and quality of life. Digital measures offer the potential for continuous, real-world assessment of mobility, enabling personalized treatment plans, remote monitoring, and earlier detection of disease progression.

Initiatives like Mobilise-D, Watch PD, PPMI, i-PROGNOSIS, and mPower have pioneered the development and validation of digital mobility measures in Parkinson's. However, translating these advancements into regulatory-accepted endpoints for clinical trials and clinical practice remains a challenge.

 

Overall Goal:

Leverage the collective knowledge and resources from previous initiatives to streamline the regulatory qualification process for digital mobility measures in Parkinson's disease, ultimately enabling their widespread use in improving patient care and accelerating drug development.

 

Specific Objectives:

Consolidate Existing Evidence: Gather and synthesize available evidence on the validity, reliability, and clinical meaningfulness of digital mobility measures in Parkinson's disease.

Assess Regulatory Landscape and Gaps: Evaluate the current regulatory framework and identify key evidence gaps hindering the qualification of digital mobility measures.

Address Evidence Gaps: Collaboratively design and execute targeted research and validation studies to address the identified gaps in evidence.

Pursue Regulatory Qualification: Work towards regulatory qualification of digital mobility measures as clinically meaningful endpoints in Parkinson's disease.

 

Potential Benefits:

Advancing Regulatory Acceptance: Streamlined development and validation of digital measures, leading to faster adoption in clinical trials and clinical practice.

Enhanced Patient Care: Improved disease management and treatment decisions through real-world, continuous monitoring of Parkinson's patients' mobility.

Efficient Drug Development: Enable the use of digital mobility endpoints in clinical trials, potentially leading to more efficient and patient-centric drug development.

Collaborative Innovation: Foster knowledge sharing and collaboration between stakeholders to advance the use of digital health technologies in Parkinson's disease mobility assessment.

 

Call for Collaboration:

This initiative invites active participation from:

Pharmaceutical companies with Parkinson's therapies in their pipeline or portfolio.

Device manufacturers creating wearable sensors or digital health technologies.

Academic Institutions: Researchers and institutions conducting clinical studies on digital mobility measures in Parkinson's.

Patient Advocacy Groups focused on Parkinson's disease.

Service providers offering expertise in areas like clinical trial design, data management, regulatory strategy, or patient engagement, who can support the development and validation of digital mobility measures.

 

Ways of contributing to a DEEP collaboration mission:

There are many ways that you can contribute to a DEEP collaboration mission. Contributions can be in the form of funding, time & expertise, or prior work you have completed and would like to contribute to the cause in exchange for others' contributions. DEEP's built-in legal framework and mission contracting services aim to simplify the process of collaboration for all partners who would like to engage. If you have questions about the ways you can contribute, please reach out to us via the DEEP website here.

 

If your organization is interested in contributing to this important initiative, please express your interest through the DEEP Interest Register.