Canada has long punched above its weight in clinical trial activity: the rigorous, multi-stage research studies that give Canadians early access to breakthrough treatments. For years, we’ve led the G7 in clinical trials per capita – a point of national pride – but that advantage is slipping away, and fast.
In 2024, clinical trial activity in Canada dropped by 11 per cent. We fell three spots globally, from fifth to eighth place, in the number of industry-run, Phase 3 clinical trials, typically the final round of testing before a new medicine can be approved and launched each year.
That same year, Canada was labelled a “next tier” country for clinical trial readiness, behind top-tier nations like France, Germany, Japan, the U.S. and China. Meanwhile, countries like Australia and the U.K. are aggressively streamlining trial start-up, patient recruitment and investment incentives to pull ahead.
Clinical trials aren’t just science experiments happening in a lab. For many patients, they’re the best – and sometimes the only – route to cutting-edge therapy or specialized care not available any other way in Canada.
Trials also anchor jobs; retain Canada’s STEM graduates; attract world-class researchers and investment; and strengthen the broader health system. They sustain hospital-based research capacity at teaching hospitals and academic health science centres across the country – capacity that takes years to build and can disappear quickly.
When trial activity declines, so does our return: less investment and research dollars; less care options for today’s patients; and a weaker pipeline for tomorrow’s breakthroughs.
So, what’s holding Canada back? Three things, mainly.
First, fragmentation: each province and territory runs its own approval and ethics processes, forcing industry sponsors to navigate a patchwork of requirements instead of a clear national path.
Second, slow trial start-up and patient recruitment push companies toward countries with faster, more streamlined systems.
Third, even when a trial succeeds here, the treatment takes far too long to reach Canadian patients through public drug plans. That is neither sustainable nor competitive.
Here’s the good news: all of this is fixable. Australia is proof of concept. A decade ago, it faced many of the same challenges Canada does now. Today, it boasts one of the fastest trial start-up times in the world, often six to 12 weeks from regulatory submission to first patient enrolled, compared with 12 to 38 weeks in Canada.
Australia got there deliberately, streamlining approvals through a single national ethics review and offering competitive tax incentives for early-phase research. It’s also in the process of developing a one-stop shop, Clinical Trials Australia, so industry sponsors and researchers face a single front door instead of multiple ones.
That kind of result doesn’t happen by accident. It takes conscious, collective effort and planning. Canada is fully capable of doing the same.
Health Canada has taken steps to modernize its regulatory processes, and that progress deserves recognition. But ambition and determination are more important now than ever. One department, acting alone, cannot fix a system this fragmented.
Competing for clinical trials means federal, provincial and territorial governments must all pull in the same direction, backed by the right market incentives. Right now, we have 13 provinces and territories competing against each other for a sliver of the global pie. Working together, they could get a much bigger share of it.
Canada has everything it takes to be among the world’s top three clinical trial destinations by 2030. We have some of the world’s top universities, the most educated population in the G7 and a strong talent pool of STEM graduates.
With genuine collaboration across governments, we could outperform the global competition with faster trial-start up, faster and broader patient recruitment and an investment environment that tells the world Canada is open for business.
Doing so would be a win for patients, a win for the health-care system and a win for the economy.
Spot on! Access doesn’t begin with HTA. It starts much before at trial selection. My question is beyond industry and policy leads, is there a role for us ‘normal humans’ to help push this forward?
The article by Dr. Bettina Hamelin and Michelle McLean makes some good points about clinical trial activity in Canada and there are definitely improvements that can be made to our clinical trial system. But it’s important to base decisions on objective evidence some of which is lacking in the article in Health Debate.
Drugs that are in clinical trials may be important therapeutic advances compared to existing treatments but that is only the case for 10-20% of new drugs. New drugs may be “cutting-edge therapy or specialized care not available any other way in Canada” but there is no guarantee that will be the case.
The 12-38 weeks that it takes to enroll patients in clinical trials only applies to British Columbia not all of Canada. The 6 weeks in Australia cited by the authors only applies if private, rather than public, research sites are involved. Moreover, the same report also notes that it takes 6-9 months in the United States and the European Union to enroll patients, just as long as British Columbia.
Canada may be a “next tier” country for clinical trial readiness but so are Sweden, the Netherlands, Denmark, Norway, and Australia, the latter of which the authors tout for its “aggressively streamlining trial start-up, patient recruitment and investment incentives”.
According to Innovative Medicines Canada, the organization headed up by Dr. Hamelin, there are about 75 clinical trials per 1 million people in Canada in 2025. The next highest number in the G7 countries is just under 50 in Italy. The number in the US is just over 40. So, whether clinical trial activity is declining in Canada appears to depend on what numbers are being used.
By all means, let’s make sure that Canadian talent is being used in conducting clinical trials in this country, but let’s make decisions based on all of the available information not just highly selected data.