Hospital patients have long played a vital role in clinical trials by testing new medications and treatments aimed at advancing human health.

And now, more and more often, patients and their family members are finding themselves on the other side of cutting-edge research, as key advisors on research teams with the scientists, doctors and other health-care professionals leading trials.

Patient and family involvement is partly driven by funding agencies, which are increasingly making patient representation on research groups a requirement on grant applications. But the research community also recognizes the unique role that a patient or caregiver perspective brings to their studies by sharing their unique insights and experiences. 

The study is looking at whether colchicine could help protect hemorrhagic stroke survivors from a second stroke or a heart attack.

“It’s not about ticking a box on a funding application,” says Dr. Aristeidis Katsanos, a Hamilton Health Sciences (HHS) neurologist and researcher with the Population Health Research Institute (PHRI), a joint institute of HHS and McMaster University. 

“Instead, it’s a research partnership that lasts throughout a trial. After all, we’re doing this research to benefit patients so it makes sense to have their representation on our research teams.

Improving outcomes for stroke patients

Katsanos is co-principal investigator for the CoVasc-ICH stroke study with HHS neurologist and PHRI senior scientist Dr. Ashkan Shoamanesh. Their research team includes Ancaster resident Francine Pilon, whose husband Allan Bignell survived a hemorrhagic stroke, or brain bleed, in 2016 only to die two years later after a second stroke. Bignell was well known in the business community as president of L3 Wescam, a world leader in electro-optic and infrared imaging technology.

The CoVasc-ICH study is evaluating the use of the drug colchicine in patients who experienced a hemorrhagic stroke by looking at whether this drug can help prevent a second, and potentially deadly stroke or heart attack from occurring. 

“People with intracranial bleeds have a high risk of experiencing a heart attack or stroke related to clots in the weeks, months or years after their brain bleeds,” says Katsanos. 

While patients who have a stroke due to a blood clot can take blood thinners to help prevent a second incident, those who experience strokes caused by bleeding can’t take blood thinners for long periods after the bleed. 

“We know that patients who experience bleeding in the brain are at risk for both clotting and re-bleeding,” says Katsanos. “There’s currently no medication available to prevent clotting without increasing the bleeding risk in this patient population. We need to find another way to improve outcomes for these patients by reducing the risk of clotting without increasing the risk of bleeding.”

The study is looking at whether colchicine could help protect hemorrhagic stroke survivors from a second stroke or a heart attack. The well-established anti-inflammatory properties of colchicine may also provide additional benefit for these patients by protecting them against inflammation-related brain damage that results from bleeding in the brain.

The research team, including Pilon, has spent two years laying the groundwork for phase three of the study which is expected to launch by the end of this year, be international in scope and last for five years. The goal is to enroll approximately 1,200 patients across eight countries in North America, Asia and Europe including 40 to 50 HHS patients. 

A patient perspective

Pilon sits on the research team with Katsanos, Shoamanesh and other PHRI researchers. The PHRI, which celebrates its 25th anniversary in November, is among the largest and most reputable research groups worldwide.

Shoamanesh was Bignell’s neurologist, and invited Pilon to join their team. The Canadian Institutes of Health Research provided a $2 million grant in support of their phase three trial, with a condition that a patient representative be part of the team, and Shoamanesh thought that Pilon would be an excellent fit. 

As well as being her husband’s main caregiver, she’s also a retired registered physiotherapist who taught physiotherapy and occupational therapy at McMaster University and the University of Guelph, and had participated in research through her work. While Pilon has a background in health care and research, her main role with the PHRI team has been to provide a patient and caregiver
perspective.

“Having Francine on our team has been a great experience, and very eye-opening,” says Katsanos, adding that this is the first time he has been part of a research team that included patient representation. “When you work directly with patients and their families, it’s incredibly motivating because you’re reminded why you’re doing this research.”

Pilon says she feels genuinely valued by the team. “They have been amazing to work with, involving me in all the processes and meetings. I can see that they’re very compassionate, and really want the whole patient-family centered approach in their research.”

Reader-friendly surveys mean better data

Study participants will be sent questionnaires to fill out and return, to give their perspective on their recovery journey so that researchers can build a scale to measure levels of disability after stroke and gauge colchicine’s effectiveness.  

“Can this drug reduce clotting and improve patient outcomes after a brain bleed?” asks Katsanos. “When we’ve finished phase three we’ll have the ultimate answer, and this could have huge worldwide implications.”

Pilon’s contributions include editing patient questionnaires, so they’re reader friendly and easy to complete. 

“Researchers want to extrapolate a lot of data from questionnaires, but in order to receive that data the patients and their caregivers need to fill them out and return them,” says Pilon. “If I can make a difference by helping motivate people to complete our questionnaires, then the research data will be that much better.” 

Motivated to help others 

While this study is coming too late for her husband, Pilon is excited about the possibility of helping other patients and families living with the fear of a second stroke or a heart attack.

“It would be so exciting to be able to make a difference in an area that’s so dear to my heart,” she says, adding, “It has been an incredible experience and a privilege to be part of such a prestigious and important research team.”