An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Beever, Daniel; Swaby, Lizzie

Abstract

Background
Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units (CTUs) with the published guidance and makes recommendations for risk-based monitoring in pragmatic trials.

Methods
An online survey of UK Clinical Research Collaboration registered CTUs was administered via email invitation. Forty-nine units were invited, and 23 responded. Respondents were also invited to share copies of risk assessment templates.

Results
Most CTUs reported using remote combined with on-site monitoring. All reported undertaking a risk assessment for Clinical Trials of Investigational Medicinal Products (CTIMPs) and 21 units did so for non-CTIMPs. Most CTIMP risk assessments used MHRA (Medicines and Healthcare products Regulatory Agency) classifications, although some also employed staff judgement. Almost all units based their monitoring on perceived risk level; this number was higher for CTIMPs (n = 22) than for non-CTIMPs (n = 19). In most cases, monitoring plans were produced. More CTUs revisited risk assessments during trials in CTIMPs (n = 21) than in non-CTIMPs (n = 18). Small numbers of units reviewed the monitoring approach always (n = 4) or sometimes (n = 9) and few used the reflection to guide future monitoring.

Conclusions
A high proportion of UK CTUs are using risk-based monitoring in the UK, as recommended by guidelines, for both CTIMPs and non-CTIMPs. This has the potential to make trials more efficient and reduce costs. However, there appears to be a lack of reflection on the value of these revised approaches. There may be a benefit in CTUs collaborating nationally to improve processes for reflection and making changes during the life course of a trial.

• Journal Article Type: Article
• Acceptance Date: Jul 29, 2019
• Online Publication Date: Sep 10, 2019
• Publication Date: 2019-12
• Deposit Date: Apr 11, 2024
• Publicly Available Date: Apr 24, 2024
• Journal: Trials
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 20
• Issue: 1
• Article Number: 556
• DOI: https://doi.org/10.1186/s13063-019-3619-6
• Public URL: https://nottingham-repository.worktribe.com/output/33027360
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3619-6