The 2009 H1N1 influenza pandemic confronted critical care researchers with a challenge: how to mobilize a research response to a rapidly emerging and incompletely understood international threat, and how to communicate the data emerging from any studies to decision-makers who were charged with leading a global clinical response. This challenge framed InFACT’s initial forays into international research collaboration. It is fair to say that we were largely unsuccessful, but that failure shaped ideas about how we might respond more effectively to future challenges.
Building on a CIHR- and PHAC-funded meeting in Toronto in 2011, and on a follow-up meeting in Pittsburgh later that year, and working in close collaboration with the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC), we embraced the concept of creating, in the inter-pandemic period, the research architecture that could be seconded to rapidly launch one or more clinical trials in response to an acute need.
The model we embraced was the platform trial. A platform trial uses Bayesian models, and evaluates multiple interventions, simultaneously and sequentially; it is, in essence, a hybrid model of research and continuous quality improvement. The resulting trial – the Randomized, Embedded Multinational Adaptive Platform (REMAP) trial – selected as its focus severe community-acquired pneumonia (CAP) as the dominant phenotype for an emerging infectious disease. REMAP-CAP has now been funded in the EU as part of the PREPARE initiative, in Australia, New Zealand, and most recently, Canada. Additional funding applications are being considered for the USA, Brazil, and Africa.
REMAP-CAP will not only explore the creation of a platform for global collaboration in pandemic research, but also build a mechanism for better international research collaboration in investigator-led clinical trials. The opportunities for, and barriers to this are a key focus of this preliminary work.