On March 18, the director-general of the World Health Organization announced the launch of an international study to test experimental treatments for COVID-19. It’s called the SOLIDARITY trial. Over 45 countries have signed up.
A key player in the Canadian arm is St. Michael’s Dr. John Marshall, a critical care physician and global expert in ICU-acquired infections like pneumonia. As founding chair of the International Forum of Acute Care Trialists (InFACT), he’s a leader in the design of clinical trials and pandemic preparedness.
We spoke with Dr. Marshall about new developments in clinical trials for COVID-19 treatments.
Why is the WHO’s announcement so important?
The WHO identified infectious pandemics as one of the top threats to global health. That’s because – as we saw with SARS, MERS and H1N1, and as we’re seeing now with COVID-19 – these pandemics are impossible to predict, and can spread rapidly throughout the world.
The SOLIDARITY trial fast-tracks studies in humans to identify the most effective treatments. The more hospitals that participate, the more critically ill patients we recruit, the better the data we’ll have on what works and for whom – and the more quickly we can roll out treatments on a wide scale.
You helped design this new clinical trials model. Tell us about that.
We’ve been studying severe community-acquired pneumonia (CAP) in infectious diseases and looking at how to conduct clinical research involving the most critically ill patients during a future pandemic. Our experience with SARS and H1N1 convinced us that to respond adequately to the next pandemic, we must have the bulk of work done in advance. That means designing research studies, obtaining ethics and regulatory approval and lining up funding.
In 2011, we hosted an international meeting at St. Michael’s Hospital that brought 100 researchers, clinicians, government officials and funding agency representatives to talk about pandemic research preparedness. Since then, the global critical care research community has worked to expedite research in the face of a future pandemic: the future is now.
What is different in this approach?
We’re investigating the disease – in this case COVID-19 – rather than a specific intervention (a potential drug, for instance). The platform, REMAP-CAP, uses a novel trial design that can test several treatments at the same time, in the same patient, to see what works and what’s safe. The results are applied to new patients in the study so they get the best treatments. Less effective treatments are dropped and new ones added for testing on a rolling basis. Right now there are 400 trials going on, and REMAP-CAP is working with SOLIDARITY to build a harmonized global trial. The scale of collaboration is unprecedented.
What is St Michael’s bringing to the global table?
We’re a premier critical care hospital and we have research expertise in areas applicable to an influenza pandemic. We set up the first Canadian research program to assess the effectiveness of the platform clinical trial for community-acquired pneumonia. We have the global experts in mechanical ventilation, people like Drs. Art Slutsky, Laurent Brochard and Chris Sinderby. And with Drs. Warren Lee and Claudia dos Santos, we have basic research expertise in the host response to infections like COVID-19.
Why should we prioritize research?
It’s key. When we see the escalation of cases in Europe and the U.S., and the massive burden of the disease as it spreads, we must be able to rapidly mobilize our research capacity. The more quickly we can generate answers, the better our response will be – for the patients we care for and the society we cherish.
What about next time?
The COVID-19 pandemic will tell us whether international collaboration for rapid deployment of clinical trials works. Can everyone come together? Can we get the infrastructure in place for a future pandemic?
We know it will be messy. It already is. The willingness to engage on this scale is creating logistical and resourcing issues.
But our hope is that we will build the capacity for the next one. And more importantly, it is changing the way the world works together.
Interested in supporting COVID-19 research at St. Michael’s Hospital? Please contact Ashley Downey, Director of Philanthropy – Principal Gifts at DowneyA@smh.ca or 416.889.3426.