Clinical trials offer a chance to try experimental treatments and move the state of science forward. Here’s what patients need to know.
For Gretta Hutton of Orillia, Ontario, signing up for a clinical trial was a no-brainer. That is, once she learned about one.
Her story started in May 2014 when she was diagnosed with stage 4 mantle-cell lymphoma, a rare form of non- Hodgkin lymphoma (NHL) that affects 6 per cent of NHL patients. Her oncologist at a nearby community hospital suggested she start standard-of-care R-CHOP chemo- therapy (each letter stands for the name of a drug used).
“He gave me two to five years with treatment,” she says.
But before she began the treatment regimen, both her sister and a neighbour looked on the ClinicalTrials.gov website and found a clinical trial of the targeted drug Imbruvica (ibrutinib) that was recruiting newly diagnosed patients with her condition. Her oncologist was unaware of the trial, but once she told him about it, hospital staff provided access to phone and fax numbers for the trial nurse. Hutton received the informed consent form, which provided details about the trial, and within days, she was in Hamilton at the Juravinski Cancer Centre, one of several Canadian centres participating in the trial. Hutton underwent additional tests to make sure she qualified — and she did.
“When the trial oncologist walked in, the first thing he said was, ‘We have lots of time to talk,’” she says. He explained the study, the medications that would be used, the risks and benefits and the steps involved in being in a trial.
Hutton was placed on either Imbruvica or placebo paired with the targeted drug Rituxan (rituximab) and the chemotherapy bendamustine — a different combination of medicines than the R-CHOP regime. She isn’t certain she received Imbruvica, but suspects she did: Her condition improved significantly and her cancer is in remission. She initially made monthly trips to Hamilton and now makes the two-hour drive from her home every other month.
“I was really sick when I first went in, so there wasn’t much to lose to try a trial,” she says. Besides, she knew she could quit any time and switch to standard care. Instead, her experience was so positive that she became a patient-spokesperson for the Canadian Cancer Clinical Trials Network, also known as 3CTN, an organization that works to increase the number of academic trials conducted in Canada and encourage patient participation.
Clinical trials, which test new treatment strategies, are opportunities for patients to “access cutting-edge technologies, new drugs and new ways of doing things (as therapies) for their cancer. We’re always trying to improve how we treat patients with cancer, be it a new drug, a new pathway (treatment protocol) or a new way of doing radiation,” says Dr. Daniel Heng, a professor of medicine at the University of Calgary and medical director of the Clinical Research Unit at the Tom Baker Cancer Centre.
A trial can investigate the effects of things like diet and lifestyle changes, new medications or novel combinations of older ones or variations in surgical techniques, he says.
“Often, patients in a clinical trial get exposed to new therapies long before they are approved or reimbursed for use,” he says — and at no cost.
PARTICIPATING IN TRIALS
According to the 2018 Cancer System Performance Report put out by the Canadian Partnership Against Cancer, between 1 per cent and 6 per cent of Canadians with cancer participated in clinical trials through 2015. Today, that number hovers between 6 per cent and 10 per cent, says Dr. Janet Dancey, a professor of medicine at Queen’s University and scientific director of 3CTN. There are multiple reasons more people don’t participate: lack of interest, worry about trying something new, concern about ending up in a trial group getting standard treatment or placebo, discomfort with being a test subject, the amount of time involved, geographic distance and the inconvenience of travelling for multiple appointments.
For Hutton, the multiple trips to Hamilton are worth it. At first, she was so unwell someone had to drive her, but now she’s healthy enough to drive herself.
According to Heng, Alberta, where his institution is located, has a higher participation rate than the United States, where it is 5 per cent. He attributes this largely to a concerted effort by the province to help patients and doctors alike become aware of clinical trials, and to find ways to help rural patients have better access. He noted that participation rates vary between different types of cancers. For example, there tend to be more trials of the more common cancers such as breast or lung, and they often recruit much larger numbers of patients. There aren’t as many trials for rare cancers.
There are also other barriers to participation for many patients. Some trials require that participants have not yet taken any cancer treatment, and patients may need to meet a certain level of health or might be disqualified if the cancer is too extensive or if they have other health-complicating issues. Some groups of people are underrepresented in cancer clinical trials, including rural and Indigenous populations and those who aren’t proficient in English or French.
“We are working on initiatives that improve these issues,” Heng says. Heng points out that all trials are different, so a patient who doesn’t qualify for one might be eligible for another. Also, some trials help patients pay for travel if distance is an issue.
Patients can even participate in trials taking place in provinces they don’t live in, but it takes extra paperwork to ensure public health coverage. “It is possible,” Dancey says. “We can figure out a way to make it work, but it takes time to get that coverage in place. And then, to be in the trial may require you to relocate to a new place.”
Advantages of clinical trials include participants getting more monitoring and tests than they might in other treatment settings, as well as a very high level of care. That’s because researchers need to know if a new treatment or regimen is working, and also about any side effects.
Participating also gives patients opportunities to help move science and treatments forward.
Clinical trials in Canada are required to meet rigorous standards. “All trials have to go through a research ethics board that includes input from medical and legal experts, patient advocates and ethicists to ensure patients are being safeguarded. There is a lot of oversight for clinical trials in Canada,” says Dr. Sharlene Gill, a professor of medicine at the University of British Columbia and spokesperson for the Canadian Association of Medical Oncologists.
Because of her experience in a clinical trial, Hutton has been able to establish a new normal in her life. She has had to make some sacrifices — she continues to take medications that cause side effects, including a suppressed immune system, potential blood clots and a risk of bleeding that means she has to refrain from riding or showing her horses. However, Hutton is convinced that her outcome is better than it would have been on standard-of-care drugs, and she says she would certainly make the same choice again.
Dancey appreciates that commitment, noting that “the only reason we have treatment now is because patients went through trials before.”
FINDING A CLINICAL TRIAL
One of the best ways to find a clinical trial is to go to the ClinicalTrials.gov website, Heng says. Canadian centres are required to register clinical trials on the site. It also lists trials from around the world.
A more local source is the Alberta Clinical Trials website, which focuses on trials available to patients within Alberta. Trials in Ontario are listed on their website or by contacting the clinical trials navigator for that site.
“Definitely ask your oncologist about clinical trials,” Heng says. “They can look to see what’s available. It helps for patients to be proactive and see what they can find on the web to open up the discussion.”