developing a roadmap for principles of global federated platform trials and their application: an infact/isaric/icc-ctn technical workshop

Platform trials are revolutionising acute care clinical research and the Irish Critical Care-Clinical Trials Network (ICC-CTN) are leading four global platform trials in pneumonia, lung failure and cardiac arrest. Platform trial design differs to traditional clinical trials: they are not once off but a whole infrastructure, can test multiple treatments at the same time, do not require a set number of participants, but instead report results as they are ready for rapid inclusion in clinical practice. Treatments that are not yet ready continue to be tested, and new treatments are added, allowing learning healthcare research. They generated 14 treatment recommendations for COVID-19 in <3 years, changing patient care. We co-hosted a meeting of 300 clinicians, researchers, patients, and policymakers (60 countries) in Toronto, Canada, with global organisations the World Health Organisation (WHO), International Forum for Acute Care Trialists (InFACT) and International Severe Acute Respiratory and emerging Infection Consortium (ISARIC). This meeting and its discussions afterward all conclude that the next step is 'Federated Platform trials', where individual platform trials can standardise and harmonise so that a trial is managed regionally but can contribute data and samples to a global effort, co-analyse results and conduct in-depth analyses leading to rapid, more efficient, globally-representative results. There is an urgent need to develop key rules as to how best to achieve this. The ICC-CTN, with InFACT and ISARIC, propose to host this technical workshop in Dublin, Ireland, to develop trials methodology identifying the Principles of Federated Platform Trials and how to apply them. This includes standard protocols, data collection, statistical analysis, sharing, collaboration and public and patient involvement with the goal to establish this reality, delivering faster, beneficial results for our patients and healthcare systems. This meeting will develop a roadmap for the global conduct of these trials for the next decade.