This article originally appeared in Saltwire newspapers across Atlantic Canada on July 11, 2024.
Dr. P.J. Devereaux, co-chair of Accelerating Clinical Trials (ACT) Canada, and Dr. Bettina Hamelin, president of Innovative Medicines Canada, provided the following opinion article.
An alarming true story was shared by a Canadian mother at a medical research conference in Hamilton, Ont. last year. Her son was diagnosed with cancer when he was only two years old. When the cancer relapsed in his brain, the family was told they would only have a few months left with him, and there were no remaining treatment options.
The family found a clinical trial with promising preclinical data at one of the largest cancer centres in the U.S. They remortgaged their home, used all their savings, and borrowed money to travel to the U.S. for treatment. The clinical trial they enrolled their son in ultimately saved his life, and today he’s a remarkable 17-year-old young man.
But what if they hadn’t moved heaven and earth to get their child in that trial? What if, like so many Canadians, their circumstances didn’t allow them to do that?
In an era where rapid advancements in medical treatments can mean the difference between life and death, Canada must modernize its approach to clinical trials.
Unified approval
The average startup time for a clinical trial can stretch to 35 weeks, which is significantly longer than other jurisdictions. Systemic inefficiencies limit access to pioneering treatments and cause unnecessary suffering for patients. By making a few changes, Canada can correct course, attract clinical research, and, most importantly, provide a lifeline for many Canadians.
First, Canada needs to streamline the approval process for clinical trials with a pan-Canadian, distributive research ethics board (REB) review and approval process with strict timelines. Currently, a trial approved in one province or centre must undergo separate approvals in others, placing us at a competitive disadvantage internationally.
Many other countries, including the UK, Australia, Sweden, and the US, have adopted a unified approval process that simplifies and accelerates the time to activate clinical trial centres. Canada also needs to adopt a standardized agreement template that minimizes redundant legal activities across Canadian healthcare facilities.
National portfolio
Second, Canada needs a national portfolio system for clinical trials that increases capacity for research and improves access for patients no matter where they live.
Portfolio systems break down regional barriers by embedding study personnel into hospitals across the country. This allows for quicker mobilization of clinical trials and is instrumental in prolonging and saving lives. Through this approach, the UK was able to launch its historic RECOVERY trial with unprecedented speed during the COVID-19 pandemic, resulting in the first major breakthroughs that saved many COVID-19 patients around the world.
The Accelerating Clinical Trials (ACT) Consortium, supported through multi-year funding from the Canadian Institutes of Health Research Clinical Trials Fund, has made strides to build a portfolio system in 20 community hospitals across Canada. While this is a great start, we need continued support to broaden this initiative.
A national portfolio system would increase access to clinical trials locally, ensuring that Canadians in big cities like Montreal or in rural areas like Fort McMurray have equal opportunities to participate in potentially life-saving research. This is particularly important for Canadians living with rare disease.
Continuity of care
Lastly, Canada needs to provide opportunity for continuity of care once a clinical trial has ended and improve access to new treatments once they’ve been approved by our regulators. Canada lags all other G7 countries in the time it takes for patients to access approved new treatments.
It takes more than two years on average for Canadians to get access, which is one year longer than many other developed countries. This is in addition to the time Health Canada requires to evaluate the efficacy and safety of a novel treatment.
This unfortunately sends a strong signal globally that commercializing a new drug is a long and arduous process in Canada. It puts us at a significant disadvantage when trying to attract more trials. As a result, our physicians have limited options to treat critically ill patients, inevitably decreasing quality of life for patients.
Achievable goals
But there is much cause for optimism. Canada has the expertise and the capability to be a world leader in clinical trials.
We punch above our weight when it comes to the calibre of our teaching hospitals, research institutions, and scientists and clinicians. Collaborations between government, researchers and the life sciences industry are already well underway. We can’t let silos and process inefficiencies hold us back.
The changes proposed here are ambitious but entirely achievable. We need to work together to set a common ambitious goal and create a national unified system that makes Canada the most efficient country in the world to conduct clinical trials. Doing so won’t just build a competitive edge and attract more clinical trials investments; it will fulfill a moral obligation to provide Canadians with the best possible health outcomes.
