ArticleTherapeutic innovation & regulatory science2026
Current Landscape of Investigator-Initiated Decentralized Clinical Trials in Japan: A Nationwide Survey.
Article in Therapeutic innovation & regulatory 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
20 authors.
Funding
Abstract
backgroundDecentralized clinical trials are becoming more widespread, driven by advances in digital technologies. However, little is known about the use of these trials in Japan.
methodsWe carried out a nationwide survey targeting 221 major clinical research institutions in Japan. Respondents were asked to report details of investigator-initiated decentralized clinical trials for which their institution was the lead facility for fiscal years 2021-2025.
resultsOverall, 82 institutions responded (37.1% response rate), including all 54 Clinical Research Core Hospitals and National University Hospitals (100% response rate), which are the institutions most likely to conduct investigator-initiated clinical research. Eighteen institutions (22.0%) reported conducting a total of 36 decentralized clinical trials, mostly at Clinical Research Core Hospitals or National University Hospitals. Twenty-one trials (58.3%) were classified as interventional studies under the Ethical Guidelines. Annual initiations increased from four in fiscal year 2021 to 15 in fiscal year 2024, and seven were reported for the incomplete fiscal year 2025. The most frequently used decentralized elements were electronic informed consent (eConsent) (14 trials, 38.9%) and online medical consultations (12 trials, 33.3%). Twenty-seven trials (75.0%) incorporated only one or two decentralized elements. Oncology was the most common disease area, although the trials spanned a wide range of therapeutic areas.
conclusionsThe use of decentralized clinical trials is gradually increasing in Japan. These trials often use hybrid approaches incorporating a few decentralized elements, such as eConsent and online medical consultations. This pattern may reflect an approach adapted to Japan's unique regulatory, healthcare, and geographical circumstances.
Indexed as
Identifiers
42732042What 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.