Findings
The integration of mobile devices into interventional research, specifically RCTs, is evolving slowly.
There is a lack of standardization in mobile outcome assessments, making it difficult to compare results across studies.
Current definitions for conventionally measured outcomes do not adequately reflect the novelty of mobile outcome assessments.
Recommendations
Emphasize validating the clinical meaningfulness of mobile outcome assessments.
Develop new mobile outcome assessments for future clinical research.
Use CTTI’s recommendations and tools for selecting appropriate mobile outcomes as trial endpoints.
Regulatory Considerations
Standardization is necessary to facilitate the acceptance and use of mobile outcomes in regulatory interventional research.
Validation of mobile outcomes is crucial for their use in regulatory decision-making.
The development of new categories or modification of current definitions may be needed to accommodate novel measures using mobile devices.