Findings
Operational inefficiencies in participant recruitment and data acquisition inflate costs and extend timelines.
Disparities in access to research due to geographic and mobility constraints limit participant diversity.
Many digital biomarkers require further validation for use in clinical trials.
Heightened need for security measures to protect against data breaches in digital trials.
Opportunities exist to improve clinical trials using real-world data from EHRs and IoT technologies.

Recommendations
Leverage existing technologies and research platforms to transform clinical trials.
Develop partnerships with technology and computational communities.
Create standard protocol templates for automation in recruitment, retention, and data collection.
Develop validation models for new devices and analyses using existing trials.
Invest in the next generation workforce in medicine, technology, and clinical research.

Regulatory Considerations
Address data privacy and security concerns in digital trials.
Provide guidance for IRBs on consenting requirements, reporting, and oversight in digital trials.
Develop empirical research on the risks and benefits of digital trials.
Educate IRBs on digital technology and its implications for clinical trials.