Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event

Area of Science:

• Digital Health
• Clinical Trial Innovation
• Health Informatics

Background:

• Digital technologies, including wearable devices and smartphone applications, facilitate decentralized clinical trials.
• These technologies enable high-frequency, sensitive health outcome measurements outside traditional clinical settings.
• However, the integration of digital endpoints presents underexplored challenges requiring interdisciplinary collaboration.

Purpose of the Study:

• To facilitate cross-sector and interdisciplinary conversations on the challenges and opportunities of digital endpoints in clinical trials.
• To identify key challenges and develop recommendations for the effective implementation of digital endpoints.
• To foster collaboration among diverse stakeholders within the digital health research ecosystem.

Main Methods:

• A multi-stakeholder Knowledge Exchange event was organized.
• Stakeholder identification involved surveys and iterative discussions.
• The event featured cross-disciplinary talks, panel discussions, small-group sessions, and audience participation via Slido.
• Data collection included event transcripts and Slido outputs, followed by post-event meetings for analysis and recommendations.

Main Results:

• Key challenges identified include patient adherence and acceptability, algorithm and software development, clinical trial design and analysis, environmental impact, and ethical support.
• Learnings for future events emphasize including funder and regulator perspectives and enhancing patient and public engagement.
• The need for additional resources and facilitation for meaningful patient involvement was highlighted.

Conclusions:

• Consortium building and collaborative, multi-disciplinary, cross-sector efforts are crucial for innovation in digital endpoint research.
• Enhanced funder recognition is needed to support multi-stakeholder projects involving patient input.
• Standardized terminology and the use of open-source software are recommended for advancing digital endpoint utilization.