The AGILE Clinical Trial Platform
The AGILE clinical trial platform is a new type of study designed for pandemic drug testing which represents a world-first for infectious diseases – capable of testing multiple potential treatments in parallel and speeding up testing by pooling control data across patient groups
The coronavirus pandemic is like nothing we’ve seen in modern times. Its transmissibility and severity have overwhelmed conventional means of managing infectious diseases, and so far quarantine – with its considerable social and economic costs – is our only effective defence.
The AGILE clinical trial platform has been launched specifically to test new COVID-19 treatments, faster than ever before. It bridges the gap between non-human trials and large-scale testing, so potential new treatments can go through the important testing stages in a matter of months rather than years, while maintaining a high level of safety at all times.
This provides the potential for one or more suitable treatment options to become broadly available for patients with COVID-19 much sooner, and ultimately, allowing us to restart society.
The MHRA (Medicines and Healthcare products Regulatory Agency) has fully evaluated this platform and given its approval. The UK regulatory body has adapted rapidly to the altered circumstances in the pandemic to help efforts against coronavirus.
Southampton Clinical Trials Unit and the Southampton NIHR Clinical Research Facility are working to support and deliver the AGILE platform and trials within it.
Royal Free Hospital
Support led by Dr Sir Michael Jacobs, clinical lead in infectious diseases at the Royal Free London NHS Foundation Trust supported by a team of consultants providing a clinical service dealing with infections.
The University of Liverpool and the Liverpool School of Tropical Medicine
The Liverpool NIHR Clinical Research facility, Liverpool University Hospitals NHS Foundation Trust, Liverpool University and the Liverpool School of Tropical Medicine are working to support and deliver the AGILE platform.
Support led by Professor Thomas Jaki based in the Dept of Mathematics and Statistics in Lancaster University.
The AGILE Initiative is made possible thanks to support provided through a variety of donors. In addition to funding provided by Unitaid and the Steve Morgan Foundation, some candidate-specific trials will be funded directly and solely through companies (for example, Ridgeback Biotherapeutics, Glaxo Smith Kline, Vir Biotechnology). Collaborative financial support has also been provided by the Liverpool School of Tropical Medicine, University of Liverpool, and Southampton Clinical Trials Unit as well as the NHS (Liverpool University Hospitals NHS Foundation Trust).