Perceived barriers and facilitators to risk based monitoring in academic-led clinical trials: a mixed methods study

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dc.contributor.authorHurley, Caroline
dc.contributor.authorSinnott, Carol
dc.contributor.authorClarke, Mike
dc.contributor.authorKearney, Patricia M.
dc.contributor.authorRacine, Emmy
dc.contributor.authorEustace, Joseph A.
dc.contributor.authorShiely, Frances
dc.contributor.funderNational University of Ireland, Galway
dc.contributor.funderHealth Research Board
dc.date.accessioned2017-10-18T09:40:16Z
dc.date.available2017-10-18T09:40:16Z
dc.date.issued2017
dc.description.abstractBackground: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a ‘gold standard’, validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists’ readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland. Methods: This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues. Results: Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants’ legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials. Conclusion: The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.en
dc.description.sponsorshipHealth Research Board (Trials Methodology Research Network (HRB-TMRN)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid423
dc.identifier.citationHurley, C., Sinnott, C., Clarke, M., Kearney, P., Racine, E., Eustace, J. and Shiely, F. (2017) 'Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study', Trials, 18, 423 (11pp). doi: 10.1186/s13063-017-2148-4en
dc.identifier.doi10.1186/s13063-017-2148-4
dc.identifier.endpage11
dc.identifier.issn1745-6215
dc.identifier.journaltitleTrialsen
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/4902
dc.identifier.volume18
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2148-4
dc.rights© 2017, the Authors. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectRisk-based monitoringen
dc.subjectICH-GCPen
dc.subjectMonitoringen
dc.titlePerceived barriers and facilitators to risk based monitoring in academic-led clinical trials: a mixed methods studyen
dc.typeArticle (peer-reviewed)en
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