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. 2020 Jan 9;21(1):59.
doi: 10.1186/s13063-019-3976-1.

Monitoring in practice - How are UK academic clinical trials monitored? A survey

Sharon B Love  1 , Victoria Yorke-Edwards  2 , Sarah Lensen  2 , Matthew R Sydes  2
Affiliations

Monitoring in practice - How are UK academic clinical trials monitored? A survey

Sharon B Love et al. Trials. .

Abstract

Background: Despite the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) encouraging the use of risk-based monitoring for trials in 2013, there remains a lack of evidence-based guidelines on how to monitor. We surveyed the academic United Kingdom Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) to find out their policy on monitoring of phase III randomised clinical trials of an investigational medicinal product (CTIMPs).

Methods: An online survey of monitoring policy with sections on the CTU, central monitoring and on-site monitoring was sent to all 50 UKCRC registered CTUs in November 2018. Descriptive data analysis and tabulations are reported using the total number answering each question.

Results: A total of 43/50 (86%) of CTUs responded with 38 conducting phase III randomised CTIMP trials. Of these 38 CTUs, 34 finished the survey. Most CTUs (36/37, 97%) use a central monitoring process to guide, target or supplement site visits. More than half (19/36, 53%) of CTUs do not use an automated monitoring report when centrally monitoring trials and all units use trial team knowledge to make a final decision on whether an on-site visit is required. A total of 31/34 (91%) CTUs used triggers to decide whether or not to conduct an on-site monitoring visit. On-site, a mixture of source data verification and checking of processes was carried out. The CTUs overwhelmingly (27/34, 79%) selected optimising central monitoring as their most pressing concern.

Conclusion: The survey showed a wide variation in phase III randomised CTIMP trial monitoring practices by academic clinical trials units within a single research-active country. We urgently need to develop evidence-based regulator-agreed guidance for CTUs on best practice for both central and on-site monitoring and to develop tools for all CTUs to use.

Keywords: Central monitoring; Clinical trial monitoring; On-site monitoring; Remote monitoring; Trial conduct.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Frequency of factors likely to trigger an on-site monitoring visit. CTU could choose multiple options. CTU clinical trial unit, No number, pt participant
Fig. 2
Fig. 2
Reasons for frequency of on-site monitoring visits. CTU could choose multiple options. CTU clinical trial unit
See this image and copyright information in PMC

References

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