The Crucial Role of Clinical Trials in Shaping the Present and Future of Cancer Treatment

Clinical trials often become tomorrow’s new standard of care, boosting many patients’ quality of life now and helping ensure that future cancer patients have continuously higher standards of care for years to come. Moreover, our understanding of cancer is evolving so quickly, we’re in a different place than we were even five years ago. Here’s a short primer on cancer clinical trials:

There are two main types of clinical trials: therapeutic trials and non-therapeutic trials. Therapeutic trials provide a specific treatment to patients to study that treatment’s impact on cancer. Non-therapeutic trials do not provide a treatment to patients but instead study important factors which help advance our understanding of cancer and its impact. For example, some non-therapeutic studies collect tissue specimens to examine the cellular structure of a cancer tumor. Other studies track epidemiological information such as the long-term health effects of chemotherapy.?At Princess Margaret Cancer Centre, we conduct both therapeutic and non-therapeutic clinical trials.

Why are clinical trials so important? Clinical trials help inform our understanding of cancer and improve prevention, diagnosis, treatment, and care. Lifesaving therapies that are offered today, such as?immunotherapy, are in place because past clinical trials led to their approval. All clinical trials are voluntary. At The Princess Margaret, we hear from our patients all the time that they want to help other people dealing with cancer by participating in clinical trials, an act of great selflessness and generosity.

What are the benefits of clinical trials to patients? Clinical trials are often the best or only treatment option for cancer patients, offering new therapies that may have fewer side effects and better efficacy than traditional treatments – and that would otherwise be inaccessible or unaffordable to most Canadians. In addition to access to the latest cancer therapies, though, research studies typically mandate a certain number of imaging tests and appointments for patients on clinical trials. For many cancer patients, more frequent check-ins are reassuring, whether they are receiving an experimental therapy or a placebo.

And, speaking of placebos … Receiving a placebo does not mean that a patient won’t receive treatment for their cancer. In fact, the opposite is true – placebos in clinical trials need to be just as good as the current standard of care. This means that when a patient participates in a clinical trial, the worst-case scenario is that they will receive the same standard, effective therapy that patients not enrolled in the clinical trial will receive, in addition to more frequent monitoring of their cancer. At Princess Margaret Cancer Centre, there are separate clinical trials teams who works closely with a patient’s care teams and are dedicated to answering questions from study participants. For more information, see the Cancer Clinical Research Unit (CCRU) Convergence Centre, led by Dr. Amit Oza.

How does Canada rank in cancer clinical trials? Canada is regarded as a leader in scientific research due to the quality and expertise of our researchers and their teams, many of whom are globally recognized for major medical discoveries and innovations, and our ability to conduct clinical research in complex therapeutic areas with diverse population bases. Canada is also the G8 leader in clinical trial productivity (number of trials by population), with cancer dominating clinical trials. Oncology is the leading area for industry sponsored clinical trials in Canada with a 31.6% “market share”, followed by infectious diseases at 15.2%, the central nervous system at 11.8%, respiratory at 8.9%, and cardiovascular at 6.7%.

Cancer clinical trials don’t just help cancer patients. As the world braces for a 77% increase in cancer cases predicted by 2050 and with cancer already being the leading cause of death in Canada, cancer clinical trials are obviously important to current and future cancer patients. However, cancer clinical trials are also important because cancer research benefits other diseases. For instance, the metabolic features of many diseases, such as diabetes, chronic kidney disease, and pulmonary disease, have a striking overlap with cancer, not to mention that several viruses are linked to cancer in humans. And it was the exploration of mRNA vaccines by cancer researchers that allowed for the rapid deployment of COVID vaccines during the pandemic.

How can we improve the cancer clinical trials system in Canada? Despite our strength in many areas of clinical trials, there are challenges with Canada’s cancer clinical trials system. For example, because we now know that each instance of cancer has unique characteristics in every person – meaning that outcomes for the same cancer subtype diagnosed at the same stage can be starkly different between two people – molecular profiling of individual patients has become critical in effective cancer treatment, as well as in clinical trials. However, molecular profiling is expensive. Moreover, timely access to off-label drugs based on a patient’s molecular profile or other evidence can be a challenge. Sometimes, requests for approval from government can be slow and are declined for funding.

At The Princess Margaret, we’re often able to bridge the gap with compassionate programs funded by philanthropy, but a systemic solution is needed, especially for Canadians living in less populated, rural or remote areas who are missing out on potentially life-saving cancer clinical trials, according to a?recent study?by a University of Alberta oncologist. Finally, there are disparities in the availability of trials for certain cancers. The University of Alberta study showed lymphoma clinical trials are the most common cancer clinical trials in Canada, with almost 33 per 1,000 projected cancer cases, while there are only 7 bladder cancer clinical trials per 1,000 cases.

From a global perspective, only 3.1% of cancer clinical trials initiated worldwide in 2022 had sites in Canada, compared to 6% in 2010. This highlights the need to better position Canada as an attractive destination for clinical trials, which could be encouraged through initiatives such as a National Ethics Approval with one informed consent, national contract language, and increased support for infrastructure at clinical trial sites, particularly in smaller centres. Additionally, there are challenges relating to the availability of medicines and Canada’s lengthy and onerous pharmaceutical funding pathway. Companies provide patient access to medicines through clinical trials, but once approved, those medicines are not always made available to patients insured through public drug plans in a timely manner. This impacts Canada’s international reputation during a period of high global competition for clinical trials development. Governments across Canada can help to attract pharmaceutical investment by addressing these pressing patient access gaps.

At Princess Margaret Cancer Centre, we open about 120 new clinical trials every year, and about 23% of our patients are on clinical trials – the highest rate in the country and a rate that is more than double the average participation rate of major cancer centres across the U.S. and U.K. But there have been almost no changes in the way we run clinical trials and approve new therapies for public funding in Canada. This needs to change.

We learned during the pandemic what is possible though: through faster ethics reviews and implementation of remote patient consent and data collection, in the UK alone over half a million people were able to take part in research into COVID-19.?A similar level of urgency, funding, and coordinated action is required for cancer clinical trials. Canada boasts the highest percentage of foreign-born citizens among all G8 countries. A diverse population combined with a universal healthcare system, top ranked universities, hospitals and research centres, and a rich history of some of the boldest and most impactful discoveries in cancer and other diseases, means that we can lead the world in cancer clinical trials. This is an opportunity we must seize – for all of Canada and the world.