Confederation of ICU clinical trials – guidance
Date: 15 December 2023
Please see request from Warwick Clinical Trials Unit:
A group of NHS collaborators and Warwick CTU are currently in the process of setting up four trials in patients with acute respiratory failure. The trials occur sequentially and concurrently along the clinical care pathway of a patient with moderate to severe acute respiratory failure. Due to the similarities in these trials and in order to reduce participant and site burden, we have joined them in a confederation, where efficiencies will be gained by running the trials under one master protocol, with the procedures and processes specific to each trial (e.g. intervention details) being detailed in individual trial protocols that will sit under the master. We plan to submit the master protocol and the domains (trials) as a single IRAS application and have had initial conversations with the HRA who are supportive of this approach. Sites will be able to review all trials in this application and then select only the trials they choose be involved in, leading to a single mNCA. We would like to discuss this approach with R&D departments in all nations to understand support required for R&D review.
We would like to invite you to get in touch at icuconfederation@warwick.ac.uk to share your perspective of what considerations we need to take into account. We would really value the views of a wide variety of set-ups and teams to incorporate these into our planning.