Trial reportClinical and translational science2026
Pioneering a Hybrid Decentralized Clinical Trial in South Korea: Assessing Feasibility, Data Integrity, and Participant Perceptions.
Trial report in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.