Integrating Personal Health Records to Improve Data Integrity in Trials With Decentralized Elements: A Pilot Study

Data integrity has long been a challenge in decentralized trials compared to traditional site-based trials. One key area impacted by these challenges is eligibility assessment, which is critical in clinical trials but often limited in depth during remote screening procedures. Integrating personal health records may help address this issue. This randomized, open-label, single-center, fully remote study evaluated the feasibility of using personal health records for eligibility assessment in 20 healthy Korean adults. During initial screening interviews, most participants reported being healthy with no significant medical history or prior medication use. However, after reviewing their personal health records, including their past 2-year health check-ups and recent 3-month prescription records, medical histories were revealed for 9 participants (45.0%, 17 cases), and 10 (50.0%, 68 cases) showed prior medication use. These findings suggest that personal health record-based interviews could substantially improve data integrity in eligibility assessments. In addition, the study incorporated various decentralized elements, such as electronic consent acquisition, self-recorded diary submission, smartwatch-based AI system for drug administration monitoring, and digital reporting of adverse events and concomitant medications. While compliance was generally adequate and participants reported high satisfaction, some experienced challenges retrieving personal health records and using the smartwatch, highlighting digital accessibility as a barrier in decentralized trials. Receiving and returning research materials through the parcel and blood sampling process at local hospitals also received high ratings, but this high score reflects Korea's unique infrastructure, including extensive delivery systems and accessible local hospitals.

Trial Registration

KCT0009827.