Yorke-Edwards Victoria, Diaz-Montana Carlos, Murray Macey L, Sydes Matthew R, Love Sharon B
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.
Health Data Research UK, London, UK.
Res Methods Med Health Sci. 2023 Sep;4(4):124-135. doi: 10.1177/26320843221147855. Epub 2022 Dec 21.
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.
We present a method for clinical trials units to track their metrics within clinical trials using descriptive statistics and visualisations.
We suggest descriptive statistics and visualisations within a SWAT methodology.
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.
The data collection for TEMPER is described in .
We show the results and discuss a protocol for a Study-Within-A-Trial (SWAT 167) for those wishing to use the method.
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.
在过去十年中，临床试验中基于风险的监测（RBM）越来越受到关注，监管机构发布了多项指南，并将其纳入了ICH GCP。然而，从实际角度来看，对于如何开展RBM缺乏详细说明，对最佳实践的理解也不足。
我们提出一种方法，供临床试验单位使用描述性统计和可视化手段在临床试验中跟踪其指标。
我们建议在SWAT方法中使用描述性统计和可视化手段。
我们使用TEMPER的指标来说明这种方法，TEMPER是在伦敦大学学院MRC临床试验单位的三项试验中进行的一项监测研究。
TEMPER的数据收集情况在……中有描述。
我们展示了结果，并为希望使用该方法的人员讨论了一项试验内研究（SWAT 167）的方案。
指标跟踪给临床试验带来的潜在益处包括加强对可能需要采取纠正措施的试验点的评估、改进对指标及其阈值影响的评估和情境化，以及在RBM中确立最佳实践。此类监测数据收集的标准化将使单个试验和整个临床试验界都受益。
