With tears in her eyes, Lisa Harder describes her three-year-old daughter Ayla’s favourite game: She’ll jump onto her mother’s back and pretend she’s riding a horse around the living room, giggling so hard she almost falls off.
It’s a game Harder might never have been able to play without her remarkable response to a new drug tested in a clinical trial at the University of Alberta.
Now Harder’s life-threatening lung condition is under control, and her life expectancy has extended from just five years to a potentially normal lifespan.
“Clinical trials are vital, in terms of being able to develop new drugs and treatments for people who are really struggling, and give them hope,” Harder says. “For me, now I get to worry about normal mom things like what Ayla’s getting into in the kitchen, and not about if I can continue to be a mom at all.”
A new collaboration between members of the Clinical Trials Alberta initiative, including the University of Alberta, the University of Calgary, and Alberta Innovates, with system co-ordination and alignment by Acute Care Alberta, aims to get Albertans like Harder into clinical trials faster, so they can access more innovative treatments.
“The pace of innovation around the world in fields ranging from cancer to genetics to metabolomics is faster than at any other time in history,” says project co-lead Lawrence Richer, a pediatric neurologist, associate dean of research in the U of A’s College of Health Sciences and centre director of the Northern Alberta Clinical Trials and Research Centre.
“I’m concerned that without this program, our capacity to test new medicines for safety and efficacy in humans could become a blocking point,” he says. “We want Alberta patients to have access to the most promising developments as soon as possible.”
The goal is to cut the time it takes for a trial to start signing up patients from the current 90+ days to 45, says Richer. A simplified master contract system and streamlined health-care system approvals, with clear steps for ethics approval, will ensure any trial, whether it’s led by a pharmaceutical company or a university researcher, can launch smoothly in the province.
The Alberta Fast-Track to Accelerate Start-up of Clinical Trials (FAST) program kicked off with $322,000 from Alberta Innovates in the spring.
“The most promising developments as soon as possible”
“The global clinical trials industry is highly competitive, and Alberta has a major opportunity to attract more investment, create high-value jobs, and give patients earlier access to new treatments and technologies, improving overall health care for Albertans,” says Raja Mita, executive director of Health System Innovation and Partnerships at Alberta Innovates.
“Through our partnership with the universities of Alberta and Calgary, we are working to reduce clinical trial startup times and strengthen Alberta’s position as a leading destination for clinical research,” Mita says.
Alberta is ideal for conducting clinical trials because of its province-wide health care system, unified electronic medical records and two research-intensive universities.
“Trials can recruit and identify potential participants in a variety of ways,” says co-lead Dr. Stephen Freedman, associate dean of clinical trials at the U of Calgary’s Cumming School of Medicine. “Sometimes it could be an abnormal blood test, a pathology result, a CT scan result or a diagnosis. You don’t have to be located in Calgary or Edmonton.”
Albertans can find out what trials are already available through the Be the Cure Alberta website, and can register their desire to be contacted about clinical trials through MyChart (accessed via myhealth.alberta.ca).
Richer, whose own mother participated in clinical trials before she passed away from metastatic cancer, envisions clinicians recruiting patients for trials as soon as they become eligible.
“When standard treatment is no longer working for a patient, the possibility of entering a clinical trial offers hope,” he says.
Every standard treatment prescribed by doctors across the country was once experimental. Current clinical trials underway at the U of A include streptococcus A and hepatitis B vaccines developed by Nobel Prize-winning virologist Michael Houghton, numerous cardiac trials led by the Canadian Vigour Centre, and new treatments for women and children.
“Now I can just live life”
When Ayla was just one, Harder found it so hard to breathe she would have to take rests on a walk to the park. She wound up in the emergency department thinking she was having a heart attack. She was eventually diagnosed with pulmonary arterial hypertension, a rare condition that affects only 4,000 Canadians.
Dr. Jason Weatherald, associate professor of pulmonary medicine at the U of A, enrolled her in a clinical trial for a new drug called sotatercept, an injection taken every three weeks to help make breathing easier. Harder started to feel relief within 10 minutes of her first injection.
The trial found that sotatercept — in combination with other therapies — significantly reduces pulmonary vascular resistance, improves exercise capacity, slows disease progression and decreases the rate of clinical worsening. It has since been approved for use in Canada and is covered by Alberta Health.
Harder can now carry her daughter around West Edmonton Mall when she’s too wiggly to walk on her own, the two take dance classes together, and Harder even gets out for 20-minute runs on her own. She’s a full-time psychologist and is also working on her doctorate.
“The effects of this new drug have been amazing,” Harder says. “Now I can function like a normal human being and keep up with Ayla and just live life.”
