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new system breaks down provincial barriers to clinical trials in canada
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sometimes the delay for a clinical trial could mean a patient no longer meets the criteria. for example, if a child has to be under the age of six and it takes two years to get the trial, they could miss the opportunity for life-saving treatment.
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maureen smith was diagnosed with a rare disease at the age of eight. she’s now 66 and says that people are living better lives today with her disease because of new drugs and therapies. they can even have children. but back when she and her family learned of her disease, there wasn’t a lot of hope or treatment. what did make a difference was joining a clinical trial for a 10-year longitudinal study in montreal, quebec, where she lived. that clinical trial extended her life and kicked off her advocacy work at a young age to give a voice to the patient experience.
“i started advocacy right then and there. so every year i went with my doctor to the mcgill university medical school to talk to students about what it was like to live with chronic disease,” says smith who now lives in ottawa, ontario.
however, after the study wrapped up, she was left to spiral into illness and disability for the next 20 years. there were no trials to enroll in related to her disease. she was an elementary school teacher trying to keep her career and benefits going, so she’d push herself to work for six months to a year and then be off for two years because of her health.
“my rare endocrine condition 60 years ago looked a lot different then. they didn’t really understand what would happen and all the attention was on the pediatric piece of it, so i started getting progressively worse with all kinds of issues and it was just terrible. i was off and on work with lots of hospitalizations in between and just really struggling.”
her disease and the rarity of it among young adults who survived, meant the possibility of another clinical trial was far from a sure thing. as well, this was before the connectivity and information of the internet. she spent a lot of time in the medical library trying to find articles on her disease and doctors who might be able to help. “it was me in the medical library. i wrote letters to different centres in the world and said, ‘where are the other kids in my condition? and are they alive and are they sick like me?’”
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she was still in touch with the montreal study team, hoping something would lead to a breakthrough and potential clinical trial. all through this she shouldered the emotional burden of not knowing if she’d ever be well again.
“i’m always thinking of living with the uncertainty of finding medication and therapies that will work for (you) and let you have a life,” she says. this is what living with a rare disease is like for many people and their families.
a second chance came at age 40 when a doctor in toronto started a trial that she participated in, and the pharma therapy worked. it took seven years to get the right dose, but she’s now living with a better quality of life and is determined to give others the same opportunity to access what could be life-changing clinical trials.
new central review system to speed clinical trial review
what’s getting her fired up these days is her work with canreview, a pan-canadian collaboration supported by the accelerating clinical trials consortium to centralize ethics reviews for clinical trials that may have multi-sites across the country.
instead of proposed clinical trials needing to jump through hoops with separate review boards in each jurisdiction, the recently launched canreview digital platform will streamline the process. now research ethics boards, institutions and researchers can connect with one main platform to go through the ethics review that’s designed to protect patients so the benefits of the research outweigh the risks.
experts say that having this collaborative framework and strict review timelines will improve the efficiency of clinical trials—especially critical in rare disease where time could save lives.
so, it’s not about shortcuts. it’s about a centralized system that will ensure the highest ethical and quality standards. a smoother process will draw leading scientists to run clinical trials across canada, making it a win for the health research community, all provinces and patients in need of critical treatments.
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over 150 people from the clinical trials community participated in one of canreview’s tactical teams to address concerns and promote system readiness. now there’s a period of refining processes and continuing the goal to remove interprovincial barriers for full participation in all jurisdictions.
“many other countries, including australia, brazil, denmark, spain, the u.k. and the u.s., have had a system like this in place for more than a decade. now, it’s canada’s turn,” noted pj devereaux, nominated principal applicant for the accelerating clinical trials consortium, in a news release. “canreview provides a clear path forward to strengthen canada’s health research environment. every province and every patient wins when we have more and better clinical trials, which canreview will facilitate.”
what happens next? research ethics boards across canada can connect with canreview to participate in the system and institutions can register as participating sites, opening the door for their researchers to submit new clinical trials or site applications for research ethics review. as well, a navigator and webinars are available to help introduce new users to the system.
‘the time is right’ for breaking down interprovincial barriers to data sharing
canada has put out the welcome mat for clinical trials.
it’s a big step forward that advocates like smith have been discussing for about 25 years when she joined the interagency advisory panel on research ethics as the first lay member. “i went to all the conferences then because i was on the panel, so i come at this from an understanding of the ecosystem. we do have some streamlining and there has been progress made, but we’re not there yet,” she says of work to set the stage for a centralized system like canreview that follows best practices from around the globe.
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“i think the time is right,” she adds of breaking down interprovincial barriers to rally against the onslaughts of tariffs imposed by the u.s. “first of all, we’re going to ride on the wave of nationalism, because if they can do it for business and they can do it for trade, then they can do it for clinical trials. clinical trials are an enterprise.”
the two main problems that need changing are making the environment friendly to attract clinical trials in canada and reducing all the waiting for people with rare diseases who will do whatever they have to do to access trials, like mortgaging their homes, smith says. sometimes the delay for a clinical trial could mean that now they no longer meet the criteria. for exampe, if they have to be under the age of six and it takes two years to get the trial while the child’s health is deteriorating, sometimes the trial comes and they’ve missed it by a day or two.
in terms of the clinical trials ecosystem, research stakeholders look at everything before they make a decision to come to launch a clinical trial, so they’re checking out the ethics review process and the regulatory framework, considering things like the following: “are they modernizing it? where will there be delays and what will make it unpalatable for them to come here?”
smith also talks about the push toward hybrid and decentralized trials to improve access for everyone, including underserved populations like first nations and rural residents. the hybrid approach is where part of the treatment can be done in your home so you don’t have to travel 500 or 1,000 km to a site. the travel isn’t easy for people who aren’t well or family members who need to take time off work to bring a child for treatment or need to arrange childcare and work leave so they can make the trip themselves.
“those trials go in front of a research ethics board, so why would it be ok for one site to say ‘yes, your patients can do the injection at home. they come in for the first one, we’ll watch them and then we’ll allow them to do it at home’ and then another site say no to that?” smith points out.
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“we should be getting the same level of ethical protection across the country. and if you straight-line it then you will be able to get that,” she says of the canreview system.
spirit of nationalism can boost canada’s health sciences sector
she comes back to the current geopolitical situation and how canada needs to embrace change. “in the rare disease community we used to say all the time, ‘there are no borders’ and rare diseases so often went to trials that were international. well, there are borders in rare disease now and the [clinical trials] in the states are getting blocked and cancelled, so the time is now,” she says for canada to lead in clinical trials.
smith also says the innovation in clinical trial methodologies and the focus on advancing equity and diversity in clinical trials and including those populations is the right step. with these changes, the ethics review process needs to adapt and build capacity. she explains that smaller ethics boards may not have the representatives to review trial submissions because they don’t typically see those kinds of trials or maybe they don’t have the training. streamlining the system taps into the shared expertise to provide a well-trained, thoughtful review process.
“we’ve got incredible capacity to run trials. we’ve got some of the best scientists in the world here,” smith says of the opportunity to make change with canreview. “it’s really a necessity that we do it and that we do it quickly because people’s lives are depending on it.”
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