Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Turning Mobile Technology Barriers Into Practical Trial Design Recommendations

Mobile technologies hold real promise for clinical trials, reducing costs while collecting high-quality, real-world health outcomes data that’s directly relevant to patients and clinicians. But adoption has been slower than the promise suggests, held back by real and perceived operational, regulatory, and data challenges. A publication in Digital Biomarkers, authored on behalf of the Clinical Trials Transformation Initiative (CTTI), lays out concrete best practices sponsors can use to move past those barriers.

What the Recommendations Cover

• Technology selection: Guidance for choosing the mobile technology best suited to a given endpoint and trial population, rather than defaulting to whatever device is most familiar or available.
• Data collection, analysis, and interpretation: Recommendations addressing how to handle the volume and complexity of continuous data streams generated by mobile sensors, and how to interpret them meaningfully.
• Data management: Practical approaches to storing, securing, and governing mobile-technology-derived data throughout a trial’s lifecycle.
• Protocol design and execution: How trial protocols need to adapt to accommodate mobile technology use from patient onboarding to ongoing engagement and compliance monitoring.
• FDA submission and inspection readiness: Specific recommendations for preparing mobile-technology-derived data and processes for regulatory submission and inspection.
• A grounding principle: The authors emphasize that the same scientific principles underpinning traditional clinical trials continue to apply when mobile technologies are involved; mobile data collection doesn’t change the underlying evidentiary bar.

Why Sponsors Should Pay Attention

This publication reframes mobile technology adoption in trials as a solvable operational problem rather than an unavoidable risk. The barriers to using mobile technologies in clinical trials are well understood and, increasingly, so are the solutions. For sponsors evaluating whether to bring wearables, sensors, or mobile apps into a trial design, these CTTI recommendations offer a practical starting framework across the full trial lifecycle, from technology selection through FDA inspection.

Koneksa Health applies this same lifecycle thinking when building digital measurement strategies for sponsors, aligning technology selection, data management, and regulatory readiness from day one, rather than solving for each in isolation.

Reference: Coran P, Goldsack JC, Grandinetti CA, et al. Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative. Digit Biomark. 2019;3(3):145-154. doi:10.1159/000503957. PMID: 32095773.