Shut out of clinical trials, community hospitals miss out on ‘cutting-edge therapy’
A network of community doctors is urgently trying to bring “cutting-edge therapy” from clinical trials to Ontario’s large community hospitals.
Although the majority of the sickest COVID-19 patients are treated in community hospitals, these hospitals do not have the same access to clinical trials as academic centres in urban areas.
Dr. Jennifer Tsang, a critical care physician and researcher at Niagara Health, says getting her hospital involved in three COVID-19 trials was urgent. “If your site was not part of a trial, your patients were potentially not going to receive cutting edge therapy.”
Due to limited drug supply, medications like remdesivir were not available in Niagara unless patients were enrolled in a clinical trial. Now, she says, patients are asking to be part of research studies. “Because of COVID, community hospitals are doing trials in a much more serious way. It pushed some hospitals into research that weren’t doing research at all.”
Dr. Alexandra Binnie, a critical care physician and researcher at Brampton Civic and Etobicoke General Hospitals, two of Ontario’s COVID-19 hotspots, says her sites’ research involvement was born out of necessity. “Seeing so many sick patients made us feel like we had to do something other than just watch people die in our hospital wards.”
Since March, Brampton and Etobicoke have been two of the highest recruiting sites in Canada’s arm of the SOLIDARITY trial, one of world’s largest trials comparing four antiviral regimens.
But participation in a World Health Organization-sponsored trial is not happenstance nor is it the norm in non-academic Canadian centres. According to Binnie, the infrastructure necessary to run trials at her hospitals would have taken a decade to develop had it not been for the urgency of the pandemic – sudden access to funding – and a visionary researcher who died in June.
Dr. Ron Heslegrave, the founding director of Clinical Trials Ontario, made enrolling patients in community hospitals achievable in the years preceding the pandemic, in part by centralizing research ethics approvals. In the months before his death, Binnie says, “He felt we must recruit for COVID-19 studies at all costs.”
Adding research to the tasks of frontline nurses and doctors may seem an unpalatable burden but Paige Gehrke, an intensive care nurse in Niagara, disagrees. “When our patients are involved in research, we are really excited. It is new and although frontline care is very fulfilling, you feel you are contributing a little bit more.”
Gehrke says her unit’s approach was proactive, inviting nurses and doctors to be part of a research advisory committee to ensure study protocols considered nuances of bedside care. The committee also developed one-page study summaries for providers, patients and their families.
While some community hospitals tout early research success, Dr. Giulio DiDiodato, a critical care physician and chief research scientist at the Royal Victoria Regional Health Centre in Barrie, says he believes COVID-19 has revealed a critical divide between academic and non-academic centres. “The deficits in our system of not having a prepared non-academic research infrastructure is patently evident in the pandemic,” he says.
According to DiDiodato, the Royal Victoria is the only hospital of five in the region participating in COVID-19 studies. He says his site is “like an island” and describes a recent example of one hospital requesting a transfer for a patient to access a COVID-19 clinical trial. “Hospitals do not accept patient transfers only for the purpose of enrollment in studies. We are creating inequity in the system, which creates an ethical conundrum.”
DiDiodato says most non-academic hospitals do not have experienced personnel or a budget to support research. He puts the onus on the healthcare system to provide more coordinated infrastructure and access to research funding.
In the development of Royal Victoria’s research program, he has encountered an uneven playing field, particularly when competing against academic sites for grants from agencies like the Canadian Institutes of Health Research.
“For us to build our research centre,” he concedes, “we have to fundraise.”
With 65 per cent of hospitalizations taking place in non-academic centres in Canada, Binnie, Tsang and DiDiodato say running clinical trials in large volume community hospitals is a no-brainer. More eligible patients, more efficient study enrollment and wider study recruitment would lead to faster implementation of study results, improved patient outcomes and lower health care costs, they say.
In addition, Binnie seeks research studies that are applicable to her patients in Brampton and Etobicoke and says, “Some communities are over-represented in downtown centres. Their patients are also much more complex. They do not fully represent the Canadian population. If you only recruit patients downtown, you will miss a huge proportion of Canada’s diverse population.”
The pandemic has brought clinical research to the forefront, and frontline nurses like Gehrke applauds her hospital for facilitating research studies as part of clinical care.
“COVID has shown us how quickly we can get research launched while ensuring it is safe. Community hospitals need to know they can do it. It takes time, effort, and people who are interested,” she says.