Regional variation in clinical-trial risks: a large-scale analysis of 585 clinical trials

ObjectivesTo assess 10 common indicators of clinical trial risks across regions.DesignRetrospective pooled analysis of routine central-monitoring outputs.Data sourcesData came from a central-monitoring platform (2015–2025), which contains data from clinical trials conducted worldwide by 46 different...

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Vydáno v:BMJ open Ročník 15; číslo 10; s. e094950
Hlavní autoři: de Viron, Sylviane, Young, Steve, Trotta, Laura, Buyse, Marc
Médium: Journal Article
Jazyk:angličtina
Vydáno: England British Medical Journal Publishing Group 17.10.2025
BMJ Publishing Group LTD
BMJ Publishing Group
Témata:
Case reports
Clinical Trial
Clinical trials
Clinical Trials as Topic - standards
Clinical Trials as Topic - statistics & numerical data
Compliance
EPIDEMIOLOGY
Humans
Patient assessment
Patient safety
Public health
Quality in health care
Regional differences
Retrospective Studies
Risk Assessment
Risk management
STATISTICS & RESEARCH METHODS
Japan
Ukraine
Clinical Trial
Risk management
STATISTICS & RESEARCH METHODS
Quality in health care
EPIDEMIOLOGY
ISSN:2044-6055, 2044-6055
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Shrnutí:ObjectivesTo assess 10 common indicators of clinical trial risks across regions.DesignRetrospective pooled analysis of routine central-monitoring outputs.Data sourcesData 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.
Bibliografie:Original research
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SourceType-Scholarly Journals-1
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-094950