Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
ABSTRACT Clinical trials with decentralized elements (DCTs) may improve accessibility and convenience by reducing the need for frequent on‐site visits; however, empirical evidence remains limited. Within a Phase 1 pharmacokinetic drug–drug interaction (DDI) study, we concurrently implemented an additional study arm incorporating decentralized elements to evaluate feasibility, data integrity, and participant perceptions compared to conventional on‐site procedures. In this open‐label, hybrid DCT, 20 healthy adults were randomized in a 1:1 ratio to either the DCT arm or the conventional arm. Between on‐site periods (Periods 1 and 3), 5‐day paroxetine dosing was administered during arm‐differentiated Period 2. During this period, DCT arm participants self‐administered paroxetine with a wearable dosing‐monitoring and remote adverse events (AEs) reporting, whereas conventional‐arm participants underwent on‐site dosing and AE reporting. Participant burden was assessed using a survey conducted at completion of the study. In Period 2, the DCT arm achieved 100% dosing adherence, whereas one participant in the conventional arm missed the on‐site dose. Wearable device records showed 2% missing data with high concordance with paper logs (mean difference, 0.24 min). AE incidence was comparable between the arms, suggesting that remote reporting maintained AE detection sensitivity. Participants rated app/web‐based methods as the least burdensome, followed by paper, wearable devices, and on‐s
Abstract
ABSTRACT Clinical trials with decentralized elements (DCTs) may improve accessibility and convenience by reducing the need for frequent on‐site visits; however, empirical evidence remains limited. Within a Phase 1 pharmacokinetic drug–drug interaction (DDI) study, we concurrently implemented an additional study arm incorporating decentralized elements to evaluate feasibility, data integrity, and participant perceptions compared to conventional on‐site procedures. In this open‐label, hybrid DCT, 20 healthy adults were randomized in a 1:1 ratio to either the DCT arm or the conventional arm. Between on‐site periods (Periods 1 and 3), 5‐day paroxetine dosing was administered during arm‐differentiated Period 2. During this period, DCT arm participants self‐administered paroxetine with a wearable dosing‐monitoring and remote adverse events (AEs) reporting, whereas conventional‐arm participants underwent on‐site dosing and AE reporting. Participant burden was assessed using a survey conducted at completion of the study. In Period 2, the DCT arm achieved 100% dosing adherence, whereas one participant in the conventional arm missed the on‐site dose. Wearable device records showed 2% missing data with high concordance with paper logs (mean difference, 0.24 min). AE incidence was comparable between the arms, suggesting that remote reporting maintained AE detection sensitivity. Participants rated app/web‐based methods as the least burdensome, followed by paper, wearable devices, and on‐site visits. Burden scores for electronic versus paper AE reporting showed no significant differences between or within arms. This study, one of the earliest reported DCTs in the Republic of Korea, demonstrated the feasibility and reliability of decentralized self‐administration with wearable monitoring and remote AE reporting. These findings support the potential of hybrid DCTs in offering efficient and participant‐friendly alternatives to conventional approaches. Study Highlights What is the current knowledge on the topic? cts70618-li-1001 What question did this study address? cts70618-li-1003 What does this study add to our knowledge? cts70618-li-1005 How might this change clinical pharmacology or translational science? cts70618-li-1007 bullet cts70618-list-1001 highlights CTS70618-abs-5001