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Why B.C. needs to build up its early clinical trial capacity

Clinical trials are critical not only in the development of drugs, but a healthy life sciences ecosystem
Alison Orth, director of Clinical Trials BC, says that the province needs to focus on building clinical trial capacity and capability

This article was originally published in Life Sciences Magazine. Read the full digital edition here.

Clinical trials are a crucial step in the development of much-needed medications, but a lack of local early-stage trials could jeopardize B.C.’s position as a leader in this area of science.

As the B.C. government looks to build the province’s life science sector, more attention is being paid to the barriers that prevent the development of local clinical trials, such as challenges in attracting and retaining talent, infrastructure needs and the need for wrap-around services to support this kind of testing.

“The life sciences sector is immensely valuable to B.C. and to the future economy of B.C. So it’s critically important in and of itself,” says B.C. Minister of Health Adrian Dix. “That access for patients in B.C. to clinical trials is also hugely valuable and so on both of those grounds, it’s very important.”

Early-phase clinical trial capacity is one of the biggest bottlenecks when it comes to conducting medical testing in the province.

The capacity issue for Phase 1 clinical trials is most starkly seen in Western Canada not having any non-cancer, Phase 1 clinical trial facilities, according to Dix.

“For B.C. companies, that has tended to mean that they conduct these trials in other jurisdictions. That has a number of effects, including the value of intellectual property leaving the province, lack of benefit to B.C. patients from the trials themselves and the real impact for the life sciences economy,” he says.

Phase 1 trials are considered the first step in human trials and are done following in-vitro and other modes of testing, says Darryl Knight, vice-president of research and academic affairs with Providence Health Care.

“Traditionally, if a company in B.C., for example, has something with therapeutic potential it would have to go to the U.S., maybe the East Coast, Australia and other places for Phase 1 trials. That makes it really difficult to bring it back into Canada to do any subsequent trials,” he says.

The province announced a new B.C. Life Sciences and Biomanufacturing Strategy in April 2023 which aims to secure B.C.’s position as a leading global hub for life sciences and biomanufacturing. Clinical trials are identified as the one of the main pillars in achieving this.

Knight says that Canada and B.C. are seen as a destination for clinical trials. Yet of the approximately 1,300 active clinical trials conducted in B.C. as of September 2022, roughly one per cent were early-phase or Phase 1 trials, according to Knight.

Canada captures roughly four per cent of the global market for clinical trials, with B.C accounting for 25 per cent of them, he says.

“The opportunity that B.C. has if we can get this clinical trial environment right will enable us to compete on the world stage,” he said. “A thriving clinical trial sector fosters innovation, encourages researchers and industry to work together and invest in these medical technologies and treatments. So, it’s crucial that we grow the clinical trials capacity in the province.”

Further compounding the issues around early-phase and Phase 1 trials is a lack of a major pharmaceutical company in Canada, says Murray McCutcheon, senior vice-president of partnering at AbCellera, a Vancouver-based biotechnology company.

“We don’t have a company operating at scale to bring new early-stage medicines into the clinics here. What we do have is a lot of early-stage biotechs and small companies that are trying to scale,” he says, adding that it is a “chicken-and-egg” problem.

Attracting and retaining talent is another focus when building clinical trial capacity and capability, according to Alison Orth, director of Clinical Trials BC.

The organization is an operating unit of Michael Smith Health Research BC, which has been working alongside the provincial government as a stakeholder in the development of B.C.’s Life Sciences and Biomanufacturing Strategy.

Their goal is to create a “robust, innovative, coordinated and person-centred clinical trials ecosystem improving health and economic outcomes for British Columbians.”

“By participating in research, you really are further advancing the integration of research and care and that has been shown to attract prominent clinicians and other health-care providers to the institutions where research is being conducted,” she says, adding that research activities can also help prevent workplace burnout in medical professions.

Having access to early-stage trials also encourages the creation of job opportunities in trial construction, implementation, analysis and regulatory affairs, says Knight.

“There are key skills that we do not have well developed in our labour pool at the moment, because we have a sector and industry that has not reached the critical mass of scale,” says McCutcheon, who clarified that AbCellera has been able to grow to a 600-person company.

“When I referenced how we you don’t have a major pharmaceutical company operating here, we don’t have biotech companies that are in many hundreds of thousands of employees that are building out the spectrum of skills that are required.”

In addition, there are not enough wrap-around services to support to these early-stage clinical trials in addition to clinical trials in general, according to Knight.

“What may not be immediately obvious is the wet lab capacity,” he said. “We need participants of trials provide biospecimens that can be analyzed for biomarkers of disease or biomarkers of response, or other types of analysis.… How do we wrap support structures around the clinical trial and wrap the clinical trial around participant so that they feel meaningfully engaged and they feel that they’re a part of something that’s going to be helping them?”

One of the solutions that Orth has been working on alongside Michael Smith Health Research BC is a clinal trial management system (CTMS).

“Health authorities, and researchers affiliated with them, can use the single system to better manage their clinical trials, and that increases their efficiency and effectiveness of running trial,” Orth says.

There are 54 “sites” where a clinical trial is being conducted that currently use this system.

Another platform that was supported by Health Research BC and Clinical Trials BC is Reach BC, which aims to help patients in the public identify research opportunities. Researchers can use it help recruit members of the public or patients for their clinical trials.

These sites also work hand-in-hand with awareness events to increase community engagement, Orth says.

Many of these issues were brought to light during the COVID-19 pandemic. It offered a chance for B.C.’s life sciences sector to shine and through that the province was “involved in all aspects of the development of vaccines against COVID-19,” Dix says.

While on one hand this offered a chance to demonstrate the province’s clinical trial capacity, the flip side is that it also highlighted the issues that are preventing more clinical trials from being conducted locally.

For Orth, the pandemic represented the need to be prepared and to bolster B.C.’s capacity and capability for health research.

“It shone a light on the value of clinical trials in other sectors and communities that hadn’t really thought about it and recognize the value that we saw for treatments and prevention of COVID-19,” she says.

Dix says that clinical trials have become a central element of the province’s life sciences sector strategy.

“What’s come out of this period of the pandemic and a period of other issues is a significant breakthrough in public policy on the question and the work of our full sector, which is making immense progress,” he says.⎜

This article was originally published in Life Sciences Magazine. Read the full digital edition here.