Findings
Patient-centeredness is a key criterion, with higher importance assigned to endpoints identified by patients as meaningful.
The tool includes predefined weighting criteria to ensure that endpoints addressing unmet needs are prioritized.
A structured rating scale facilitates the comparison of novel endpoints across different therapeutic areas.
Digital measurement technologies, such as wearables and ePROs, are increasingly considered viable novel endpoints.
The tool provides a standardized approach to endpoint selection but requires user input to tailor scores to specific trial needs.

Recommendations
Clinical researchers should use the tool to systematically evaluate novel endpoints before incorporating them into study designs.
Weighting criteria should be adapted based on the specific therapeutic area and patient population to reflect real-world priorities.
Endpoint selection should incorporate regulatory and scientific considerations to ensure alignment with study objectives.
Digital health technologies should be leveraged where appropriate to support novel endpoint validation and implementation.
Stakeholder engagement, including patient advocacy groups, should be integrated into the endpoint selection process.

Regulatory Considerations
Novel endpoints should align with FDA and regulatory body expectations for evidence generation and validation.
The tool does not replace regulatory guidance but can serve as a structured framework for early-phase endpoint assessment.
Sponsors should document endpoint selection rationale in submissions to regulatory agencies.
Digital health endpoints should comply with data integrity and privacy regulations, including HIPAA and GDPR.
Ongoing validation and post-market evidence generation may be required for novel digital endpoints used in pivotal trials.