Where innovation begins: the power of Phase 1 clinical trials in Canada

Most of us couldn’t make it through our morning routine without the successful outcome of a clinical trial. When you put in your contact lenses, apply sunscreen, or pop an ibuprofen to ease a headache, you’re benefiting from years of testing conducted by innovative teams of researchers, clinical staff, and physicians. “Any intervention today is the result of yesterday’s clinical trials,” explains Dr. Darryl Knight, president of Providence Research. “Any drug you take, any device you’re wearing for your health—I think that really puts the importance of clinical trials in perspective.”

Clinical trials consist of multiple phases designed to keep patients safe while evaluating the efficacy of the intervention being tested. Each phase is important, but Dr. Knight shares that Phase 1—the first time that the drug or device is given to a human—is the most critical. “It’s the gateway,” he says.

In 2025, Providence Health Care is poised to become a leading provider of these crucial trials: the newly opened Clinical Trials Unit (CTU) at Mount Saint Joseph Hospital is now the only dedicated non-cancer Phase 1 unit in Western Canada.

Despite its name, Phase 1 is not where a treatment’s journey begins. All medical interventions begin with an idea, which is typically followed by years of preclinical computer work, petri dish experiments, preclinical models, testing on human 3D bioprinted tissues, biomanufacturing, and obtaining Health Canada approval to conduct the trials.

Even then, the intervention isn’t yet given to a person with the condition it aims to treat. In a Phase 1 clinical trial, the drug or device is administered to healthy humans. Dr. Knight gives the example of an asthma puffer: “First, you try that puffer in healthy volunteers [people who do not have asthma], and if it’s safe and well-tolerated, then you can try it on an asthmatic patient.” The results of the Phase 1 trial determine whether the treatment moves on to the next phase.

In Western Canada, there are no other Phase 1 Clinical Trials Units solely devoted to non-cancer trials. In coming years, the Clinical Support and Research Centre (CSRC) connected to the new St. Paul’s Hospital on the Jim Pattison Medical Campus will have the potential to run all phases of trials. But for now, local biotech and pharmaceutical companies have access to the most fundamental phase at Mount Saint Joseph.

The eight-bed Phase 1 Clinical Trials Unit at Mount Saint Joseph was created thanks to a $4.2 million investment from the BC Ministry of Health and a further $600,000 from Michael Smith Health Research BC.

Participants may stay overnight or for up to a week for hospital staff to safely monitor them. Due to the CTU’s location—right below Mount Saint Joseph’s high acuity unit—there is swift access to emergency care in the unlikely event of an adverse reaction.

The Clinical Trials Unit will be able to conduct clinical trials on a myriad of conditions: respiratory, cardiac, renal, immune, ophthalmology, and more. Most fall into the categories of drugs, small molecule inhibitors, antibodies, and gene modifiers.

The global clinical trials market was worth roughly $69 billion CAD in 2021 and is predicted to increase to $111 billion by 2028. “Canada has done pretty well; it’s captured roughly 4% of the clinical trials market to date,” says Dr. Knight, “but it’s fallen behind in Phase 1 trials—outside of cancer—because we haven’t had that capacity.”

This means that Canadian biotech companies have had to go to the U.S., Australia, or India to conduct Phase 1 trials. Once a therapeutic is being tested abroad, it’s difficult to bring it back home for Phase 2 and beyond. By the time an approved drug reaches our shores, it may be too late for some patients.

He adds that BC’s biomanufacturing capability enhances the possibilities of these trials. “Now, we can develop a molecule, make enough of it, and put it into a person without actually leaving the province,” he says. “It’s an opportunity for industry and academia to be engaged for the entire duration of a potential therapeutic’s life cycle—from investigational product to approved therapy.”

Not only will the tested products stay in Canada, but the people testing them will, too. “It’s an absolute ecosystem of training opportunities and employment opportunities,” Dr. Knight points out. He stresses the importance of the multidisciplinary training that will take place, and of the high-income jobs that are created when Phase 1 trials can be done locally: “It’s fuelling economic growth.”

The impact of the Phase 1 Clinical Trials Unit at Mount Saint Joseph can’t be understated—not just for the patients and families that will gain access to better, faster care through rigorously tested interventions, but for Canada at large. “It’s a catalyst for economic development, a catalyst for health care improvement, and a catalyst for health innovation in general,” says Dr. Knight.

Researchers identify a potential medical intervention.

Laboratory testing is conducted.

The treatment is tested in healthy human volunteers for the first time. Doctors determine if the treatment is safe for people and find the best way to administer it. In some circumstances, the treatment may not be suitable for healthy volunteers, and patients are the first to be administered the drug. This is the case for cancer drugs, for example.

The medicine or intervention is given to humans with the condition that it aims to treat. Doctors determine how well it works, what the ideal dosage is, and identify any side effects.

Doctors determine if the treatment is better than other treatment options available. If it is more effective than others on the market, Health Canada may approve it.

After the treatment is approved, doctors continue to monitor patients and study potential long-term side effects.

Discover how local scientists, physicians, and innovators are working together to bring life-changing treatments from the lab to the bedside—and how you can be part of the journey.

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