seizing the opportunity: how canada can take the reins in clinical trials
15 minute read
from left to right: susan marlin, president and ceo of clinical trials ontario; barry stein, president and ceo of colorectal cancer canada; dr. pj devereaux, co-chair of the accelerating clinical trials (act) consortium; and dr. megan bettle, executive director of clinical trials at the canadian institutes of health research (cihr).
clinical trials ontario
why are clinical trials so important for canada? these research studies test new medical interventions, like drugs, devices or other treatments, to evaluate their safety and effectiveness in people. and sometimes, those interventions mean the difference between life and death.
“one of our patient partners did a presentation for us, and she showed a picture of her son at the time, who was two years of age and was critically ill. they live in southern ontario, and they were told that their son was going to die. he had cancer, and there was no treatment,” says cardiologist dr. pj devereaux, co-chair of the accelerating clinical trials (act) consortium, a national initiative to improve the efficiency of randomized clinical trials in canada.
“the mom, who was super-impressive, did not accept this. she did research and found a clinical trial in upstate new york. they remortgaged their house. they took their child to upstate new york, enrolled him in this clinical trial. and in the next picture she showed us, her son was 18 years of age.”
new innovative treatments can save lives or change them in significant ways. healthing spoke with devereaux and other leaders in clinical trials research after the recent clinical trials ontario conference in toronto.
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new therapies proven in clinical trials change lives
devereaux also mentions a young man who grew up beside him who became a talented musician.
“he was having a wonderful life and then developed crohn’s disease and was terribly sick for a decade. he’s at the point where he is scheduled to get a colectomy (to remove part of his colon). the morning he’s supposed to have surgery, he phones the surgeon and says, ‘i can’t go through with this.’ a week later, he gets enrolled in a clinical trial, gets a new drug, and the drug completely changed his life.”
having a robust and efficient clinical trial system in canada will attract more biotechnology companies and others to conduct clinical trials here, help bring new therapies to market for people who need them, and support significant economic growth, he says.
but the challenge becomes, how do we do this?
there are a number of strategic plans underway to seize the opportunity in canada, just as the spirit of nationalism grows. the national institutes of health in the united states, under president donald trump, has cut billions of dollars from critical research projects. these cuts include clinical trials testing treatments for cancer, brain diseases and other health problems that a recent report said affected more than 74,000 people enrolled in the experiments.
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canada is building research opportunities with top international talent
while many top scientists in the u.s. are now out of a job, canada is looking to build research opportunities and discovery. the federal government has launched a $1.2 billion push to attract leading international researchers. the 12-year investment will recruit and support more than 1,000 individuals advancing research in key fields, including doctors and scientists.
devereaux, who is also a senior scientist at the population health research institute of mcmaster university and hamilton health sciences, leads initiatives with act to invest in funding trials of canadian biotech companies to anchor biopharmaceutical companies in canada that produce treatments that can be sold here and around the globe.
“we basically have to invest in ourself. we’re asking for the government to make a $2.5 billion endowment that would then provide the interest, $100 million annually, that can create a fund that would allow us to support phase 3 trials (the final phase after phases 1 and 2 to ensure safety and efficacy). we would need industry to match or triple that money, but that’s real money, so that industry will not pass it up,” he says.
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“in the phase 3 trials, for every five that we do, we’d expect at least one to lead to a regulatory approval, which leads to annual big global sales and hopefully that company becomes an anchor biopharmaceutical company in canada.”
push to invest in biotech and keep canadian discovery in canada
while canada has a population of 44 million people, there are many countries in europe far smaller that have big pharmaceutical companies. denmark is a prime example with nova nordisk and leo pharma.
“we don’t have a single large pharmaceutical company in canada, not one that we own,” he explains, noting the need for tax incentives for businesses and citizens to invest in canadian biotech.
“america and europe are not the ones destined to have big pharma. they have it because they invest more money. we have to create the incentive structure that will actually invest in our canadian biotech and then keep it canadian.”
he highlights the historical example of insulin, the canadian discovery in 1920 that changed the world. before that time, if your child developed diabetes, they’d likely die within the year. danish researcher august krogh befriended john macleod, the director of the university of toronto lab, who guided the work of frederick banting and his assistant charles best to create insulin.
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krogh and macleod were instrumental in founding novo nordisk, and the company “made all its money for 80 years on insulin, and they were the biggest distributor of insulin in europe with all their focus being on metabolic medicine,” says devereaux. “then they also bought a glp-1 (ozempic) … and then they were printing money and, you know, that should have been a canadian company.”
novo nordisk has paid the danish government, a country of less than six million people, $2.3 billion in income taxes in 2023, cbs news reports. “novo nordisk accounts for nearly half of the country’s gdp growth, according to an analysis by denmark’s danske bank. denmark’s economy could be facing a risk due to its dependence on one sector and one company.”
as devereaux adds, economic health dramatically affects human health.
“even just from a tax point of view, and think about all the people that you employ. if you find yourself unemployed, you will quickly realize how the economy has a profound impact on your health. so, we should be looking to improve health while growing our economy.”
to move this forward, act brought together over 100 biotech companies and over 300 researchers to bridge the knowledge gap so that biotech understands what researchers are working on. “we had companies do three-minute elevator pitches on their technology and then respond to questions. then we held competitions to fund studies that would address canadian biotech,” says devereaux.
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“the reality is that when a big international trial is happening that’s funded by industry, it is the global office that ultimately decides which countries it’s going to happen in. if it was a canadian-owned company, that would absolutely happen in canada, there’s no doubt about it.”
from a government perspective, one of the key players in advancing clinical trials in canada is the canadian institutes of health research (cihr), where dr. megan bettle, executive director of clinical trials, wants to see canadian researchers get the opportunities to take their work forward.
“we have really, really good scientists in canada and clinical trials are an essential part of the work that goes into supporting the medicines that people take,” says bettle, who worked for health canada for more than a decade before joining cihr. she also commends the quality of academic institutions and research hospitals that contribute to the many impressive studies that are published in leading journals. innovative medicines canada, the national association representing canada’s pharmaceutical industry, reports that canada has the highest number of clinical trials per capita among the g7 countries.
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“the theme for the work i’ve done is really about making sure that canadians have access to the medicines they need when they need them. and clinical trials are a huge part of that because that’s where we get the evidence that demonstrates how well a medicine works, whether it’s more cost-effective or better than other options, and how safe is it? and that’s the key thing that holds the whole system together.”
cihr: canada is a world leader in scientific research
she notes that clinical trials in canada are highly regulated and well structured, with the protection and support of the participants as the primary goal. another advantage for canada as a leader in clinical trials is our diverse population, which means that you can trust the evidence from the trials to be generalized. pharmaceutical companies want to make sure that the evidence from clinical trials will be applicable to many different populations.
work in clinical trials has to be collaborative, where best practices can be shared across provinces and countries. since covid-19, bettle says there’s been a huge amount of work by the world health organization (who) to lead efforts into strengthening clinical trial processes around the world.
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“we’re part of those conversations, bringing global research funders together to talk about how we support clinical trials and how we can make them better.”
who has published guidance on best practices, and cihr has refined its approach, funding trials that have researchers engaging with patients when they develop their trials and enrolling populations who are representative of the people who need the results of the trial. “we are supporting really good research. it’s challenging because there’s never enough funding to support all of the high-quality research in canada,” she says of parcelling out $100 million for clinical trials every year.
overall, cihr makes a $1 billion annual investment in health research, which includes funds for act and other research networks that bring people in the ecosystem together to work on improvements.
“being part of that process is exciting. it’s good to see projects start from ideas and then go through to the end,” bettle says.
other initiatives to improve clinical trials include engaging community hospitals in research, and training for scientists and clinicians to learn more about how to conduct clinical trials and come together to share best practices. inclusivity and access to clinical trials are also a focus, with testing for decentralized trials. this follows australia’s tele-trials program that uses technology and logistics to address similar challenges of population concentration and large numbers of remote and rural people.
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“so there is a main trial site in a bigger institution, but certain functions of the trial are delivered through satellite sites,” she says. “maybe blood can be taken at your local clinic, or maybe you can go somewhere closer to you to get this assessment, and it’s a way of really broadening access to trials.”
bettle also acknowledges concerns that research is segregated and siloed from the delivery of healthcare, in part because research funding is federal and healthcare delivery is provincial. “a huge conversation that’s been happening over the past couple of years is how do you get research more embedded in clinical care, whether that means that some of the tests that are done are standard tests or that the people involved in trials or the people delivering healthcare have more opportunities to take part in trials, so bringing those pieces together is a challenge for sure.”
as well, access to health data has long been a hurdle in a country that is disconnected because of the provincial delivery of healthcare. as clinical trials are highly regulated for patient safety and privacy, there are layers of review and layers of approval, which add delays to starting trials, she notes.
in this vein, act has worked to facilitate agreements between institutions to allow data and sample sharing to boost efficiency.
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streamlining research ethics review system to make canada more attractive
the consortium has also helped roll out another major project, canreview, to centralize ethics reviews that are required to protect patients so that the benefits of the research outweigh the risks. now, research ethics boards, institutions and researchers with multi-site trials can connect with one digital platform instead of waiting for approvals from separate review boards in each jurisdiction.
susan marlin, president and ceo of clinical trials ontario (cto), describes canreview as a significant win: “we’re on the cusp of implementing a single research ethics review system in canada that will really make things more efficient, make canada more attractive and help us break down barriers, all the while upholding the highest ethical standards. this will be a first for canada, so we’re very excited.” she recalls discussions around the initiative several years ago, and seeing it come to fruition shows the commitment to advancing clinical trials in canada.
“the researchers have always called for it. i hope that this will help buoy their spirits as they’re working through some of the more challenging pieces of doing this.”
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it’s a move supported by her colleagues in pharma, medtech and biotech who are “telling us all the time where this is happening elsewhere and how it makes them more comfortable doing trials in those locations.”
marlin says the patient participant community getting access to clinical trials more quickly is another pull for situating clinical trials in canada. cto has surveyed public opinion on clinical trials and willingness to participate, with 70 per cent willing to participate if given the opportunity. many respondents in the 2015 ipsos poll saw both societal and personal benefits of clinical trials. a high percentage agreed that clinical trials “may help advance science” (78 per cent) and “may help save or improve lives of patients” (78 per cent), followed by “may help improve my disease or condition” (68 per cent). another poll was done in 2022 with similar results, she says.
in marlin’s view, despite the upheaval during the pandemic, canadians still trust doctors, medicine and science, and “doing things in an evidence-based way matters.” the rigour of clinical trials in canada is important.
“there is so much work going on across our country in our hospitals, in our universities and many other places that’s all about seeking better care for patients. every day, these are the people, and we’re talking about tens of thousands of people, that are focused on creating better treatments for patients. and it only works because canadians are willing to work along with us when we do these clinical trials.”
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last year, marlin was diagnosed with breast cancer and benefited from the advancements in treatments, proven by clinical trials, where a dye is injected beforehand to determine which nodes are most active in cancer growth. this way, chemo and surgery are more targeted and effective.
“for me, it was a bit of a full circle experience,” she says. “these are treatment decisions that i’m benefiting from now when my oncologist comes in or my radiation oncologist, they come in, and they’re telling you the data, and you know you’re one per cent better survival if you do this or recurrence if you do that.”
she also says we are well-positioned to continue to grow our capacity for clinical trials. with rising global uncertainty, canada remains a “very certain, reliable, open, free country for people to live and work in. you can be here as a company. your family can be here with you. these are all things that were counted on in other places that aren’t so reliable these days.”
further, canada is renowned for successful research and evidence-based practices in medicine, she says, along with high-calibre research facilities. all these merits make a “very attractive package” to draw more clinical trials, create jobs, and impact patient health and the economy.
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u.s. pharma pressures to lower drug prices a ‘five-alarm fire’ for canada
despite efforts to bring more clinical trials to canada and turn canadian innovations into long-term economic wins, there’s trouble brewing south of the border that could have dire impacts on canadians. barry stein, president and ceo of colorectal cancer canada, says there’s a “five-alarm fire coming” that needs attention. “nobody has actually seen any of the smoke or flames yet, but it’s coming.”
president trump’s efforts to pressure drug companies to lower prescription drug prices for americans could have serious consequences for clinical trials and drug access and affordability for canadians, stein says.
president trump’s most-favored-nation (mfn) pricing model ensures that americans do not pay more than the lowest prices set in other developed nations, although legal experts warn of problems ahead: “if pharmaceutical companies are forced to accept lower profits in the u.s., they may try to compensate by raising prices in markets that currently benefit from lower-cost drugs,” says a report from harvard law school.
“this undermines global health equity, as countries with universal health care systems or limited budgets could see diminished access,” stein says. “in essence, the u.s. would be exporting its high-cost model, potentially turning an american pricing reform into a global affordability crisis.”
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pharma companies could hike canadian list prices to protect u.s. revenues, which would chip away at our affordability advantage—despite the regulatory oversight we have in place with the patented medicine prices review board and the pan-canadian pharmaceutical alliance (pcpa), which negotiates prices with drugmakers on behalf of provincial, territorial and federal health insurance plans.
there’s a possibility that pharma and biotech companies could start to exit the u.s., moving to countries where they can test, produce and access markets quickly.
stein knows the stakes are high for late-stage cancer patients who need access to expensive new treatments, including some that may come at the eleventh hour through participation in clinical trials.
“we get fast access to some of the newer drugs because of our proximity to the u.s., because of our excellent researchers here and a good place to do clinical trials and investment in life sciences. but if all that goes away, i don’t think we’ll get as fast access, and they may not launch in canada.”
he says there are still systemic problems in lengthy, complex clinical trial processes, along with the lag between health canada approval of the therapy and market release, which would deter u.s. investment.
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“so how we counter that is really important,” he says of the need for change. “we have to reform the way we do clinical trials in canada to make it more accessible and to make the launching of these clinical trials easier and faster.”
his focus is in oncology, where “participation in canada in oncology trials as a whole ranges between two and seven per cent, so very low. certain centres will recruit fast because they’re major cancer centres, like princess margaret in toronto, for example, but we’re not getting to the community outside of those larger centres,” he says of advocacy for more equity, diversity and inclusion in trials to ensure treatments work for everybody. “we also really need to be equitable in terms of giving people that opportunity to participate in the trials.”
informing patients about relevant clinical trials is a key challenge
stein notes that most people, including patients, are not aware of the opportunities in clinical trials and may even view clinical trials in a negative way, thinking that they will be a “guinea pig” or receive a placebo, but that’s not how it works. “clinical trials in oncology are a new drug versus the standard of care. so at minimum you’re getting the standard of care.”
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creating awareness of clinical trials in canada is a challenge, but it’s on the radar, experts agree.
devereaux points out that even if people are sick in a hospital, they won’t hear about a high proportion of the trials that are relevant to their health that are happening in their hospital. why?
“it’s not because their doctors or nurses are against the trial, but it’s not their trial. their doctors and nurses are really busy trying to take care of patients, so this trial gets lost, forgotten about,” at the expense of you or your loved one.
while some aspects of clinical trials in canada are sobering, especially when they hit close to home, there’s momentum and thought leaders committed to driving change.
“we have to get the message out to canadians and do a better job to make them realize the importance of clinical trials. what people don’t realize is, if you became sick or your loved one became sick and you had to go to the emergency tonight, the only reliable treatments come from randomized controlled trials. so you’re praying that someone before you was in a clinical trial and we know what the right treatment is,” devereaux says, noting there’s truly a need for more trials and participation.
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“we’ve not yet cured disease…it’s important for people to know that so that they’ll realize, ‘hey, i’ve benefited from so many people before me who went in clinical trials. and i should be part of the cure and be in the next trial.’”
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