Chronic obstructive pulmonary disease (COPD) is a major global health burden, significantly impacting patients' quality of life and leading to increased healthcare costs. Mobility impairment is a key manifestation of COPD, limiting daily activities and contributing to disease progression. Digital measures, such as wearable sensors and mobile applications, offer the potential for continuous, real-world assessment of mobility in COPD, enabling personalized treatment plans, remote monitoring, and early intervention.

Several public-private partnerships, such as the Mobilise-D consortium, the COPD Biomarker Qualification Consortium (CBQC), and the PROactive consortium, as well as academic institutions, have made significant progress in developing and validating digital mobility measures for COPD. 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 advance the regulatory qualification process for digital measures of mobility in COPD, 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 COPD.

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 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 COPD.

 

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 COPD 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 COPD mobility assessment.

 

Call for Collaboration:

This initiative invites active participation from:

Pharmaceutical companies with COPD therapies in their pipeline or portfolio.

Device manufacturers creating wearable sensors or digital health technologies.

Academic Institutions: Researchers and institutions conducting clinical studies or developing digital technologies for COPD management.

Patient Advocacy Groups: Organizations representing COPD patients, providing valuable insights into patient needs and priorities related to mobility.

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.

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