Rheumatoid arthritis (RA) is a chronic inflammatory disease that significantly impacts patients' pain experience and mobility, leading to decreased quality of life. While traditional clinical assessments provide valuable information, they may not fully capture the day-to-day fluctuations and real-world impact of these symptoms. Digital measures, particularly wearable sensors and mobile applications, offer the potential for continuous, objective assessment, enabling personalized treatment plans and improved disease management.

 

Initiatives like Mobilise-D and IMI-PainCare, alongside academic research, have made progress in developing digital measures for pain and mobility in RA. 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 measures of pain and mobility in RA, 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 measures for pain and mobility in RA.

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

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

Pursue Regulatory Qualification: Work towards regulatory qualification of digital pain and mobility measures as clinically meaningful endpoints in RA.

 

Potential Benefits:

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

Enhance Patient Care: Improve disease management and treatment decisions through real-world, continuous monitoring of RA patients' pain and mobility.

Efficient Drug Development: Enable the use of digital 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 RA assessment and management.

 

Call for Collaboration:

This initiative invites active participation from:

Pharmaceutical companies with RA therapies in their pipeline or portfolio.

Device manufacturers creating wearable sensors or digital health technologies for pain and mobility assessment.

Academic Institutions: Researchers and institutions conducting clinical studies on digital measures of pain and mobility in RA.

Patient Advocacy Groups focused on rheumatoid arthritis.

Service providers offering expertise in areas like patient engagement, clinical trial design, data management, or regulatory strategy.

 

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 you have questions, or if your organization is interested in contributing, please reach out to us here: