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

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dc.contributor.author Hurley, Caroline
dc.contributor.author Sinnott, Carol
dc.contributor.author Clarke, Mike
dc.contributor.author Kearney, Patricia M.
dc.contributor.author Racine, Emmy
dc.contributor.author Eustace, Joseph A.
dc.contributor.author Shiely, Frances
dc.date.accessioned 2017-10-18T09:40:16Z
dc.date.available 2017-10-18T09:40:16Z
dc.date.issued 2017
dc.identifier.citation Hurley, 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/s13063-017-2148-4 en
dc.identifier.volume 18
dc.identifier.startpage 1
dc.identifier.endpage 11
dc.identifier.issn 1745-6215
dc.identifier.uri http://hdl.handle.net/10468/4902
dc.identifier.doi 10.1186/s13063-017-2148-4
dc.description.abstract Background: 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.sponsorship Health Research Board (Trials Methodology Research Network (HRB-TMRN) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central en
dc.relation.uri https://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.uri https://creativecommons.org/licenses/by/4.0/
dc.subject Risk-based monitoring en
dc.subject ICH-GCP en
dc.subject Monitoring en
dc.title Perceived barriers and facilitators to risk based monitoring in academic-led clinical trials: a mixed methods study en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Patricia Kearney, Epidemiology & Public Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: patricia.kearney@ucc.ie en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder National University of Ireland, Galway
dc.contributor.funder Health Research Board
dc.description.status Peer reviewed en
dc.identifier.journaltitle Trials en
dc.internal.IRISemailaddress patricia.kearney@ucc.ie en
dc.internal.IRISemailaddress f.shiely@ucc.ie en
dc.identifier.articleid 423


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© 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. Except where otherwise noted, this item's license is described as © 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.
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