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.
Keywords: Risk-based monitoring; Study-Within-A-Trial (SWAT); central monitoring; centralised monitoring; clinical trials.