ArticleTherapeutic innovation & regulatory science2026
Analysis of Serious Breach Cases Reported in the EU Clinical Trials Information System: Quantitative and Qualitative Assessment.
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
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSerious breaches are significant deviations that may compromise participant safety or data integrity in clinical trials. Public reports in the EU CTIS offer a valuable, though limited, opportunity to examine reporting practices and identify potential operational gaps. This study used a mixed-methods approach to analyze publicly available CTIS serious breach notifications.
methodsAll publicly available CTIS serious breach notifications were reviewed. Quantitative variables included (i) the interval from breach occurrence to sponsor awareness and (ii) the interval from sponsor awareness to public posting in CTIS. Qualitative assessment employed descriptive content analysis to categorize breach themes.
resultsMost cases were assigned to the Protocol category (n = 50, 72.5%), followed by the Regulation category (n = 12, 17.4%). Breaches involving both Protocol and Regulation occurred in 7 cases (10.1%). The occurrence-to-awareness interval had a median of 50 days (n = 67; Q1-Q3: 9-130; range: 0-1996). The awareness-to-public-posting interval had a median of 7 days (n = 67; Q1-Q3: 6-25; range: 0-381). Qualitative analysis identified nine higher-order theme families, including Investigational Medicinal Product (IMP) management and concomitant therapy, allocation and blinding integrity, eligibility and informed consent, safety management and regulatory reporting, and data integrity and documentation (ALCOA+).
conclusionPublic CTIS serious breach notifications offer a useful, though incomplete, perspective on trial conduct issues under the Clinical Trials Regulation. Because key details, such as competent-authority assessments, are not publicly available, these findings should be interpreted with caution.
Indexed as
Identifiers
42469522What 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.