ArticleBMJ open2025
Regional variation in clinical-trial risks: a large-scale analysis of 585 clinical trials.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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
1 citing paper in PubMed.
- Semaglutide in Japanese participants with metabolic dysfunction-associated steatohepatitis: a subgroup analysis of the ESSENCE trial.Journal of gastroenterology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess 10 common indicators of clinical trial risks across regions.
designRetrospective pooled analysis of routine central-monitoring outputs. DATA SOURCES: Data came from a central-monitoring platform (2015-2025), which contains data from clinical trials conducted worldwide by 46 different sponsors and contract research organisations acting on behalf of sponsors. Trial sites were grouped into seven geographic regions-North America, Central/South America, Western Europe, Eastern Europe, Africa/Middle East, Asia, Pacific-to assess regional differences in monitored clinical-trial risks.
main outcome measuresPrimary outcome-Relative Key Risk Indicator (KRI) risk score, defined as the relative risk in the selected region in comparison to the expected risk computed using data across all regions globally for 10 common risks usually assessed in clinical trials.
resultsA total of 585 studies involving 56 189 sites comprising data from all regions of the world were used in the analysis. No obvious concerns were identified regarding the conduct of reliable clinical research in any region. However, for some KRIs (eg, off-schedule visit rate, protocol deviation rate and screen failure rate), there was substantial variability observed of relative risks across regions. Conversely, some other KRIs (eg, visit-to-entry cycle time and adverse event reporting rate) had a very narrow distribution across all regions.
conclusionsThese results highlight regional differences across some common risks that may help clinical trials sponsors to plan future trials and take prospective measures to reduce KRI-related risks in some regions of the world.
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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.