Findings
There is a lack of accepted DHT-derived endpoints for labeling claims, with most endpoints categorized as secondary measures.
Barriers include sponsor uncertainty, a burdensome qualification process, and the need for shared standards and data.
Key evidence required includes demonstrating the safety, reliability, and meaningfulness of endpoints in specific trial contexts.
Collaboration among stakeholders, including regulators, patients, and technology providers, is essential for advancing endpoint development.
Engagement with regulatory bodies, such as FDA and EMA, is critical to align endpoints with evidentiary and regulatory standards.

Recommendations
Engage Early and Collaboratively: Engage with regulators, patients, and technology providers early in the process to ensure alignment on trial design and endpoint validation.
Focus on Fit-for-Purpose Validation: Ensure DHTs and endpoints are validated for their intended contexts of use, with evidence supporting their reliability and relevance.
Use Exploratory Endpoints in Early Trials: Include novel endpoints in early-phase trials and observational studies to build evidence for regulatory submission.
Promote Knowledge Sharing: Develop shared databases and resources to standardize data collection and analysis across trials.
Incorporate Meaningful Measures: Align endpoints with patient-reported outcomes and clinical assessments to ensure they capture meaningful health improvements.

Regulatory Considerations
Use tools like the FDA’s Critical Path Innovation Meetings (CPIM) to obtain early feedback on endpoint development.
Distinguish between device validation and endpoint validation, ensuring clarity in regulatory submissions.
Provide specific examples of how endpoints and technologies will be used to demonstrate their value and mitigate risks.
Ensure endpoints align with regulatory definitions of clinically meaningful outcomes, such as changes in health status that matter to patients, caregivers, and clinicians.
Address interoperability, privacy, and compliance concerns to meet regulatory and ethical standards.