Trial Methodology

Trial Methodology

Central Statistical Monitoring

The team has expertise in using statistical methods to monitor trial data as it is collected. This is an efficient and cost-effective way to ensure data quality, patient safety and trial integrity. Statistical methods are used to highlight errors and omissions, detect outliers, check for low variance to identify unusual correlations that may suggest scientific misconduct or improper data collection. By distinguishing sites that require on-site monitoring and source data verification, trial resources can be allocated appropriately, avoiding the need to visit all sites

Trial Management

Expert trial managers with the training and experience to overcome operational challenges are often the difference between the success and failure of a clinical trial. Yet, trial managers are often overlooked in terms of recognition, value and status. Danielle Beaumont et al. highlight some of the key barriers to achieving this and makes suggestions on how they can be addressed within clinical trials units registered with the UK Clinical Research Collaboration

Methods of consent taking

The the consent procedure used in emergency trials needs to be adaptable depending on the clinical situation and the capacity of the eligible participant.

Environmental impact of clinical trials

Clinical trials are energy intensive and produce substantial greenhouse gas emissions. We need to establish awareness about the broader consequences of health care and research, and through awareness increase the pace of action to avert one of the most important global challenges of our time.