Findings
Widespread use of mobile technologies in clinical trials is impeded by perceived challenges.
Scientific and technical challenges affect decision-making around using mobile technology for data capture.
Concerns include choosing appropriate technology, data collection and analysis, ensuring data authenticity, and designing protocols.

Recommendations
Use CTTI’s framework for mobile technology selection to assist sponsors.
Conduct feasibility studies prior to launching trials.
Engage with regulatory authorities early to discuss endpoint appropriateness and validation processes.
Secure data generated by mobile technologies using recommended practical approaches.
Optimize data quality to minimize variability and ensure robust conclusions.

Regulatory Considerations
Engage with the FDA early in the trial design process.
Ensure data integrity and security throughout the data life cycle.
Maintain open dialogue with regulatory authorities regarding trial-specific strategies for data collection and sharing.