Canada’s clinical trials system is failing Canadians with cancer. I know this as a cancer surgeon and researcher — and as the spouse of someone thriving despite advanced-stage cancer thanks to molecular testing, experimental therapies and enrolment in a clinical trial abroad at personal expense.
While unprecedented innovations in research have led to an explosion of novel cancer treatments — molecular, immuno-oncology and cell therapies — there have been almost no changes in the way we run clinical trials and approve new therapies for public funding in Canada.
This outdated approach hurts cancer patients. With so many new treatments coming down the therapeutic pipeline, it is critical that we transform the process for testing, approving and funding therapies, so the increasing number of Canadians diagnosed with cancer each year can benefit.
Clinical trials are often the best or the only treatment option for cancer patients, offering novel therapies that may have fewer side effects and better efficacy than traditional treatments and that would otherwise be inaccessible or unaffordable to most Canadians.
Participating in clinical research also gives patients hope.
As a new report from CONECTed — a network of oncology patient groups — notes, Health Canada regulations around trial design and monitoring are complicated and outdated, creating complexity and delays in initiating and completing trials. This discourages sponsors from opening trials in Canada and investigators from initiating these trials at their cancer centres.
A lack of molecular testing in Canada compounds the problem.
For many cancer clinical trials, patients need to have molecular testing on their tumours to determine if their cancer harbours the mutated gene the trial therapy is targeting. Unfortunately, no province funds comprehensive molecular testing and a recent report from the coalition Access to Genomic Testing states that most provinces are wholly unprepared to provide it, even if funding were available.
That leaves it up to cancer patients to pay for these costly tests themselves. For many, the $2-5K price tag is simply unaffordable, leaving them unable to participate in the trial. This also discourages industry trials from even being offered in Canada because it is too challenging to find the specific patients who meet the eligibility.
Even when trials are open in Canada, they are often only available at one or two large-volume cancer centres. The burdensome regulatory Health Canada framework makes it too onerous and costly to open a clinical trial site that can only expect to enrol a couple of patients. While delegated or virtual treatment is acceptable for clinical care, it is not allowed for the oversight of clinical trial patients. As a result, cancer patients wishing to take part must travel to the location of the trial, which may be costly and inconvenient – or inaccessible.
Adding to these barriers is a mindset in government and hospital leadership that views research as separate from clinical care. While grounded in efforts to ensure patient safety, this separation is now creating obstacles for patients to access the best cancer care.
Fixing the system will require policy and practice changes at the federal, provincial and hospital levels.
The federal government must accept new ways of designing and administering clinical trials. While there must be no compromise on safety, there is room to imagine a system that is faster, more efficient, more cost-effective and geographically accessible to all Canadians.
Canada should have a single, centralized research ethics board to review the ethical conduct, safety and privacy considerations of a clinical trial. Cancer centres should be allowed to form networks that enable operations as a single “site” for clinical trial administration and patient enrolment with delegated and virtual options for participation.
These changes would encourage sponsors to open trials in Canada and make it easier for patients to enrol at any site on a network’s list, enabling access to clinical trials closer to home.
Provincial governments must also be forward-thinking in their approach to funding molecular and other diagnostic tests, supporting not just the proven targets of yesterday, but also those being evaluated in clinical trials today, many of which will define future therapy.
Hospitals must also need to embrace a culture of research and be incentivized to engage in clinical trials.
Hospital leaders must recognize the value of research and integrate it into their care paradigms and deliverables, so more patients have access to innovative cancer treatments.
Cancer patients do not have the luxury of time. We need to transform all aspects of the clinical trials system now, so patients have the opportunity to participate and live with hope.
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About the author:
Dr. Rebecca Auer is a Surgical Oncologist and Director of Cancer Research at the Ottawa Hospital Research Institute.
