Findings
There is a lack of standardized methodologies for deriving meaningful change thresholds for digital endpoints (DEs).
Challenges exist in identifying DEs that capture the most meaningful concepts to patients.
There is a need for further unification and synergy of efforts in the field, especially given the absence of clear cross-agency regulatory frameworks.

Recommendations
Form multidisciplinary task forces to develop consensus expert guidance recommendations.
Improve transparency and sharing of learnings within the industry.
Engage with regulatory bodies early and frequently throughout the DHT development process.
Use anchor-based methods as the primary approach for deriving meaningful change thresholds.
Ensure DEs reflect concepts that are meaningful to patients.

Regulatory Considerations
Early and frequent engagement with regulators is crucial.
DEs must reflect meaningful patient concepts and be validated early in the development process.
Anchor-based methods are preferred by regulatory authorities for deriving meaningful change thresholds.