Findings
1. Challenges related to patient privacy and lack of sufficient validation for digital endpoints.
2. Lack of transparency in endpoint calculations and operational challenges.
3. Added complexities due to software version changes and regulatory unknowns.

Recommendations
1. Increase patient-centricity and reduce patient burden through digital health technologies.
2. Foster collaboration among pharmaceutical companies, regulators, academia, and technology companies.
3. Embrace innovation and ensure senior leadership support for digital health initiatives.
4. Utilize real-time data access to enrich clinical trial data sets.
5. Implement outpatient sampling to augment decision-making processes.

Regulatory Considerations
1. Request feedback from regulatory agencies as part of the development plan for outpatient sampling.
2. Consider the FDA’s guidance on bioanalytical method validation for dried blood sampling.
3. Note examples of regulatory acceptance of digital biomarkers as primary or secondary endpoints.