Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics.

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 d

SUBMITTER: Yorke-Edwards V 

PROVIDER: S-EPMC7615148 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature