Yorke-Edwards, Victoria;
Diaz-Montana, Carlos;
Murray, Macey L;
Sydes, Matthew R;
Love, Sharon B;
(2022)
Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics.
Research Methods in Medicine & Health Sciences
10.1177/26320843221147855.
(In press).
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Abstract
Background: Over the last decade, there has been an increasing interest in risk-based monitoring (RBM) in clinical trials, resulting in a number of guidelines from regulators and its inclusion in ICH GCP. However, there is a lack of detail on how to approach RBM from a practical perspective, and insufficient understanding of best practice. Purpose: We present a method for clinical trials units to track their metrics within clinical trials using descriptive statistics and visualisations. Research Design: We suggest descriptive statistics and visualisations within a SWAT methodology. Study Sample: We illustrate this method using the metrics from TEMPER, a monitoring study carried out in three trials at the MRC Clinical Trials Unit at UCL. Data Collection: The data collection for TEMPER is described in DOI: 10.1177/1740774518793379. Results: We show the results and discuss a protocol for a Study-Within-A-Trial (SWAT 167) for those wishing to use the method. Conclusions: The potential benefits metric tracking brings to clinical trials include enhanced assessment of sites for potential corrective action, improved evaluation and contextualisation of the influence of metrics and their thresholds, and the establishment of best practice in RBM. The standardisation of the collection of such monitoring data would benefit both individual trials and the clinical trials community.
| Type: | Article |
|---|---|
| Title: | Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1177/26320843221147855 |
| Publisher version: | https://doi.org/10.1177/26320843221147855 |
| Language: | English |
| Additional information: | © The Author(s) 2022. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
| Keywords: | Risk-based monitoring, clinical trials, central monitoring, centralised monitoring, Study-Within-A-Trial (SWAT) |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10162460 |
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