Findings
There is a lack of research on patient perspectives regarding the use of digital health technologies in clinical trials.
Digital health technologies offer opportunities to reduce participant burden and streamline operations but require effective engagement strategies.
Protocols need to address safety signals and data contexts not covered by traditional designs.

Recommendations
Engage patients and research sites early and often in planning digital health trials.
Ensure that outcome measurements meaningful to patients are identified before selecting digital health technologies.
Conduct feasibility or pilot studies with representative patient populations prior to trial launch.
Provide thorough descriptions of digital health technologies in informed consent documents.
Ensure sites have appropriate infrastructure and training for digital health trials.

Regulatory Considerations
Protocols should address safety signals not previously observed with traditional designs.
Communicate clearly about data confidentiality risks to participants.
Ensure informed consent documents provide clear guidance on expectations and responsibilities.