Digital Endpoints: Definition, Benefits, and Current Barriers in Accelerating Development and Adoption

Area of Science:

• Digital health
• Biomedical engineering
• Health informatics

Background:

• Health status and disease progression are assessed using defined criteria called endpoints.
• Digital endpoints leverage sensor-generated data, often from free-living environments, for health monitoring.
• Examples include smartphone microphones for cognitive impairment and activity monitors for sickle cell disease drug effects.

Purpose of the Study:

• To analyze the current state of digital endpoints.
• To unify perspectives from various stakeholders involved in digital endpoint development and deployment.
• To identify collaborative challenges for widespread adoption.

Main Methods:

• Analysis of the current landscape of digital endpoint technology and application.
• Synthesis of viewpoints from regulators, physicians, researchers, and consultants.
• Identification of key challenges hindering broad adoption.

Main Results:

• Digital endpoints offer authentic patient experience assessment and potential drug discovery cost reductions.
• The shift towards home care and telehealth necessitates digital health characterization.
• Widespread adoption hinges on technical development, supportive environments, and data analysis ecosystems.

Conclusions:

• The future of digital endpoints depends on interdisciplinary collaboration and evidence of their efficacy.
• Addressing challenges in data analysis and ecosystem development is crucial.
• Cooperative efforts are essential for the broad adoption of digital endpoints in healthcare.