Findings
Patient technologies were used across 55 countries, with mobile applications (53%) and wearable devices (33%) being the most common technologies.
Common data issues included data transmission failures, duplicate or missing data, and integration challenges with other datasets.
Factors like technical literacy, device usability, and preferences for paper-based alternatives affected adoption rates, particularly in elderly populations.
Varying broadband connectivity, importation hurdles, and compliance with regulations like GDPR posed significant challenges.
Most sponsors (54%) were willing to reuse technologies, citing improved retention, compliance, and remote monitoring capabilities as key benefits.
Recommendations
Consider patient demographics, such as age and technical literacy, when selecting and implementing technologies.
Offer multi-format training for sites, patients, and monitors, and provide robust support systems to address technical and compliance issues.
Risk Mitigation: Anticipate potential issues like data loss, non-compliance, and technical failures by incorporating backup processes into protocols.
Conduct feasibility assessments for site infrastructure and regulatory compliance in target regions to minimize delays.
Regularly gather experiential feedback from patients to refine technologies and improve future trial designs.
Regulatory Considerations
Seek advice from regulators to ensure patient technologies align with clinical trial protocols and data submission requirements.
Ensure Compliance with GDPR and Local Regulations: Address privacy concerns and adapt technologies to meet country-specific requirements.
Prepare Documentation for Importation: Account for additional time and costs related to import licenses and customs requirements.
Plan for the impact of technical updates on clinical data reliability and regulatory submissions.