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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Published in:	BMJ open Vol. 15; no. 10; p. e094950
Main Authors:	de Viron, Sylviane, Young, Steve, Trotta, Laura, Buyse, Marc
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 17.10.2025 BMJ Publishing Group LTD BMJ Publishing Group
Subjects:	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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Abstract	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.
AbstractList	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. To assess 10 common indicators of clinical trial risks across regions. Retrospective pooled analysis of routine central-monitoring outputs. 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. Primary 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. A 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. These 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. Objectives To assess 10 common indicators of clinical trial risks across regions.Design Retrospective 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 measures Primary 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.Results A 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.Conclusions These 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. To assess 10 common indicators of clinical trial risks across regions.OBJECTIVESTo assess 10 common indicators of clinical trial risks across regions.Retrospective pooled analysis of routine central-monitoring outputs.DESIGNRetrospective pooled analysis of routine central-monitoring outputs.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.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.Primary 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.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.A 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.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.These 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.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.
Author	de Viron, Sylviane Buyse, Marc Trotta, Laura Young, Steve
Author_xml	– sequence: 1 givenname: Sylviane orcidid: 0000-0003-3890-557X surname: de Viron fullname: de Viron, Sylviane email: sylviane.deviron@cluepoints.com organization: CluePoints SA, Louvain-la-Neuve, Belgium – sequence: 2 givenname: Steve surname: Young fullname: Young, Steve organization: CluePoints Inc, King of Prussia, Pennsylvania, USA – sequence: 3 givenname: Laura surname: Trotta fullname: Trotta, Laura organization: CluePoints SA, Louvain-la-Neuve, Belgium – sequence: 4 givenname: Marc surname: Buyse fullname: Buyse, Marc organization: Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, Hasselt, Belgium
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Cites_doi	10.4155/cli.14.116 10.1093/rheumatology/keaa043 10.1002/sim.6294 10.1186/1477-7525-4-79 10.1177/1740774512447898 10.1177/2168479014546336 10.4103/2229-3485.86880 10.1177/2168479014529573 10.1080/19466315.2016.1164751 10.1007/s43441-021-00341-5 10.1177/03000605221143284 10.3389/fmed.2022.966220 10.1097/01.NCC.0000305730.95839.83 10.1177/2168479014546335 10.1007/s43441-024-00613-w 10.1002/(sici)1097-0258(19991230)18:243.0.co;2-o 10.1177/1740774519862564 10.1007/s10147-015-0877-5 10.1002/ejhf.326 10.1007/s43441-022-00470-5 10.1177/2168479015618696 10.1002/(SICI)1097-0258(19991230)18:24<3435::AID-SIM365>3.0.CO;2-O
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References	Talbot, Connor, Austin (R25) 2022; 50 Ferreira, Girerd, Rossignol (R28) 2015; 17 Venet, Doffagne, Burzykowski (R18) 2012; 9 Barnes, Katta, Sanford (R5) 2014; 48 Buyse, George, Evans (R12) 1999; 18 Trotta, Kabeya, Buyse (R20) 2019; 16 Im, Liu, Kim (R16) 2008; 31 George, Buyse (R10) 2015; 5 Gough, Wilson, Zerola (R4) 2016; 50 Wilson, Provencher, Gough (R3) 2014; 48 Kermani, Politis Virk (R14) 2011; 20 (R15) 2006; 4 Kurihara, Crawley, Baroutsou (R26) 2022; 9 Keebler, Teng, Chia (R27) 2020; 59 Tominaga (R17) 2014; 48 de Viron, Trotta, Schumacher (R8) 2022; 56 de Viron, Trotta, Steijn (R7) 2023; 57 de Viron, Trotta, Steijn (R11) 2024; 58 Desmet, Venet, Doffagne (R21) 2017; 9 Timmermans, Venet, Burzykowski (R9) 2016; 21 Desmet, Venet, Doffagne (R19) 2014; 33 Bhatt (R13) 2011; 2 2025111907122807000_15.10.e094950.1 de Viron (2025111907122807000_15.10.e094950.8) 2022; 56 Keebler (2025111907122807000_15.10.e094950.27) 2020; 59 2025111907122807000_15.10.e094950.19 Tominaga (2025111907122807000_15.10.e094950.17) 2014; 48 2025111907122807000_15.10.e094950.18 2025111907122807000_15.10.e094950.16 2025111907122807000_15.10.e094950.15 Wilson (2025111907122807000_15.10.e094950.3) 2014; 48 de Viron (2025111907122807000_15.10.e094950.7) 2023; 57 2025111907122807000_15.10.e094950.14 2025111907122807000_15.10.e094950.12 2025111907122807000_15.10.e094950.11 2025111907122807000_15.10.e094950.10 Kurihara (2025111907122807000_15.10.e094950.26) 2022; 9 Barnes (2025111907122807000_15.10.e094950.5) 2014; 48 Gough (2025111907122807000_15.10.e094950.4) 2016; 50 Bhatt (2025111907122807000_15.10.e094950.13) 2011; 2 2025111907122807000_15.10.e094950.6 Talbot (2025111907122807000_15.10.e094950.25) 2022; 50 2025111907122807000_15.10.e094950.9 2025111907122807000_15.10.e094950.2 2025111907122807000_15.10.e094950.28 2025111907122807000_15.10.e094950.24 2025111907122807000_15.10.e094950.23 2025111907122807000_15.10.e094950.22 2025111907122807000_15.10.e094950.21 Trotta (2025111907122807000_15.10.e094950.20) 2019; 16
References_xml	– volume: 5 start-page: 161 year: 2015 ident: R10 article-title: Data fraud in clinical trials publication-title: Clin Investig (Lond) doi: 10.4155/cli.14.116 – volume: 59 start-page: 3023 year: 2020 ident: R27 article-title: Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials publication-title: Rheumatology (Sunnyvale) doi: 10.1093/rheumatology/keaa043 – volume: 33 start-page: 5265 year: 2014 ident: R19 article-title: Linear mixed-effects models for central statistical monitoring of multicenter clinical trials publication-title: Stat Med doi: 10.1002/sim.6294 – volume: 4 start-page: 79 year: 2006 ident: R15 article-title: Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance publication-title: Health Qual Life Outcomes doi: 10.1186/1477-7525-4-79 – volume: 9 start-page: 705 year: 2012 ident: R18 article-title: A statistical approach to central monitoring of data quality in clinical trials publication-title: Clin Trials doi: 10.1177/1740774512447898 – volume: 20 year: 2011 ident: R14 article-title: Language & culture in global clinical trials publication-title: Appl Clin Trials – volume: 48 start-page: 536 year: 2014 ident: R5 article-title: Technology Considerations to Enable the Risk-Based Monitoring Methodology publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014546336 – volume: 2 start-page: 124 year: 2011 ident: R13 article-title: Quality of clinical trials: A moving target publication-title: Perspect Clin Res doi: 10.4103/2229-3485.86880 – volume: 48 start-page: 702 year: 2014 ident: R17 article-title: Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014529573 – volume: 9 start-page: 1 year: 2017 ident: R21 article-title: Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials publication-title: Stat Biopharm Res doi: 10.1080/19466315.2016.1164751 – volume: 56 start-page: 130 year: 2022 ident: R8 article-title: Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring publication-title: Ther Innov Regul Sci doi: 10.1007/s43441-021-00341-5 – volume: 50 start-page: 3000605221143284 year: 2022 ident: R25 article-title: The impact of the 2022 Ukraine/Russian conflict on cancer clinical trials publication-title: J Int Med Res doi: 10.1177/03000605221143284 – volume: 9 start-page: 966220 year: 2022 ident: R26 article-title: The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines publication-title: Front Med doi: 10.3389/fmed.2022.966220 – volume: 31 start-page: E17 year: 2008 ident: R16 article-title: Asian American Cancer Patients’ Pain Experience publication-title: Cancer Nurs doi: 10.1097/01.NCC.0000305730.95839.83 – volume: 48 start-page: 529 year: 2014 ident: R3 article-title: Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1 publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014546335 – volume: 58 start-page: 483 year: 2024 ident: R11 article-title: Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials publication-title: Ther Innov Regul Sci doi: 10.1007/s43441-024-00613-w – volume: 18 start-page: 3435 year: 1999 ident: R12 article-title: The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials publication-title: Stat Med doi: 10.1002/(sici)1097-0258(19991230)18:243.0.co;2-o – volume: 16 start-page: 512 year: 2019 ident: R20 article-title: Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring publication-title: Clin Trials doi: 10.1177/1740774519862564 – volume: 21 start-page: 38 year: 2016 ident: R9 article-title: Data-driven risk identification in phase III clinical trials using central statistical monitoring publication-title: Int J Clin Oncol doi: 10.1007/s10147-015-0877-5 – volume: 17 start-page: 893 year: 2015 ident: R28 article-title: Geographic differences in heart failure trials publication-title: Eur J Heart Fail doi: 10.1002/ejhf.326 – volume: 57 start-page: 295 year: 2023 ident: R7 article-title: Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes publication-title: Ther Innov Regul Sci doi: 10.1007/s43441-022-00470-5 – volume: 50 start-page: 8 year: 2016 ident: R4 article-title: Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2 publication-title: Ther Innov Regul Sci doi: 10.1177/2168479015618696 – ident: 2025111907122807000_15.10.e094950.22 – ident: 2025111907122807000_15.10.e094950.18 doi: 10.1177/1740774512447898 – ident: 2025111907122807000_15.10.e094950.24 – ident: 2025111907122807000_15.10.e094950.1 – ident: 2025111907122807000_15.10.e094950.14 – volume: 48 start-page: 702 year: 2014 ident: 2025111907122807000_15.10.e094950.17 article-title: Competitive Strategies for Japanese Clinical Trial Sites: A New Approach to Quality publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014529573 – volume: 9 start-page: 966220 year: 2022 ident: 2025111907122807000_15.10.e094950.26 article-title: The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines publication-title: Front Med doi: 10.3389/fmed.2022.966220 – volume: 59 start-page: 3023 year: 2020 ident: 2025111907122807000_15.10.e094950.27 article-title: Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials publication-title: Rheumatology (Sunnyvale) doi: 10.1093/rheumatology/keaa043 – ident: 2025111907122807000_15.10.e094950.15 doi: 10.1186/1477-7525-4-79 – volume: 50 start-page: 8 year: 2016 ident: 2025111907122807000_15.10.e094950.4 article-title: Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2 publication-title: Ther Innov Regul Sci doi: 10.1177/2168479015618696 – ident: 2025111907122807000_15.10.e094950.28 doi: 10.1002/ejhf.326 – volume: 57 start-page: 295 year: 2023 ident: 2025111907122807000_15.10.e094950.7 article-title: Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes publication-title: Ther Innov Regul Sci doi: 10.1007/s43441-022-00470-5 – volume: 56 start-page: 130 year: 2022 ident: 2025111907122807000_15.10.e094950.8 article-title: Detection of Fraud in a Clinical Trial Using Unsupervised Statistical Monitoring publication-title: Ther Innov Regul Sci doi: 10.1007/s43441-021-00341-5 – ident: 2025111907122807000_15.10.e094950.11 doi: 10.1007/s43441-024-00613-w – ident: 2025111907122807000_15.10.e094950.16 doi: 10.1097/01.NCC.0000305730.95839.83 – volume: 48 start-page: 529 year: 2014 ident: 2025111907122807000_15.10.e094950.3 article-title: Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 1 publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014546335 – volume: 2 start-page: 124 year: 2011 ident: 2025111907122807000_15.10.e094950.13 article-title: Quality of clinical trials: A moving target publication-title: Perspect Clin Res doi: 10.4103/2229-3485.86880 – ident: 2025111907122807000_15.10.e094950.6 – ident: 2025111907122807000_15.10.e094950.23 – ident: 2025111907122807000_15.10.e094950.2 – volume: 48 start-page: 536 year: 2014 ident: 2025111907122807000_15.10.e094950.5 article-title: Technology Considerations to Enable the Risk-Based Monitoring Methodology publication-title: Ther Innov Regul Sci doi: 10.1177/2168479014546336 – volume: 16 start-page: 512 year: 2019 ident: 2025111907122807000_15.10.e094950.20 article-title: Detection of atypical data in multicenter clinical trials using unsupervised statistical monitoring publication-title: Clin Trials doi: 10.1177/1740774519862564 – ident: 2025111907122807000_15.10.e094950.19 doi: 10.1002/sim.6294 – ident: 2025111907122807000_15.10.e094950.12 doi: 10.1002/(SICI)1097-0258(19991230)18:24<3435::AID-SIM365>3.0.CO;2-O – ident: 2025111907122807000_15.10.e094950.10 doi: 10.4155/cli.14.116 – ident: 2025111907122807000_15.10.e094950.21 doi: 10.1080/19466315.2016.1164751 – volume: 50 start-page: 3000605221143284 year: 2022 ident: 2025111907122807000_15.10.e094950.25 article-title: The impact of the 2022 Ukraine/Russian conflict on cancer clinical trials publication-title: J Int Med Res doi: 10.1177/03000605221143284 – ident: 2025111907122807000_15.10.e094950.9 doi: 10.1007/s10147-015-0877-5
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Snippet	ObjectivesTo assess 10 common indicators of clinical trial risks across regions.DesignRetrospective pooled analysis of routine central-monitoring outputs.Data... To assess 10 common indicators of clinical trial risks across regions. Retrospective pooled analysis of routine central-monitoring outputs. Data came from a... To assess 10 common indicators of clinical trial risks across regions.OBJECTIVESTo assess 10 common indicators of clinical trial risks across... Objectives To assess 10 common indicators of clinical trial risks across regions.Design Retrospective pooled analysis of routine central-monitoring...
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SubjectTerms	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
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Title	Regional variation in clinical-trial risks: a large-scale analysis of 585 clinical trials
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