Kim Yoonjin, Huh Ki Young, Yu Kyung-Sang
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Clin Transl Sci. 2025 Jun;18(6):e70267. doi: 10.1111/cts.70267.
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.
与传统的基于站点的试验相比，数据完整性长期以来一直是分散式试验中的一项挑战。受这些挑战影响的一个关键领域是资格评估，这在临床试验中至关重要，但在远程筛查程序中往往深度有限。整合个人健康记录可能有助于解决这一问题。这项随机、开放标签、单中心、完全远程的研究评估了在20名健康韩国成年人中使用个人健康记录进行资格评估的可行性。在初始筛查访谈中，大多数参与者报告身体健康，没有重大病史或既往用药史。然而，在查看他们的个人健康记录，包括过去两年的健康检查和最近三个月的处方记录后，发现9名参与者（45.0%，17例）有病史，10名（50.0%，68例）有既往用药史。这些发现表明，基于个人健康记录的访谈可以显著提高资格评估中的数据完整性。此外，该研究纳入了各种分散式元素，如电子同意书获取、自我记录日记提交、基于智能手表的药物管理监测人工智能系统以及不良事件和伴随用药的数字报告。虽然依从性总体上足够，参与者报告满意度较高，但一些人在检索个人健康记录和使用智能手表时遇到了挑战，凸显了数字可及性是分散式试验中的一个障碍。通过包裹接收和返还研究材料以及在当地医院进行血液采样过程也获得了高分，但这个高分反映了韩国独特的基础设施，包括广泛的递送系统和可及的当地医院。试验注册号：KCT0009827。
