Sunnybrook Health Sciences Centre is not only a hospital and Canada’s largest trauma centre.
As an institution committed to inventing the future of healthcare, it is also a major centre of medical research with more than 500 clinical trials currently underway.
Clinical trials help advance medicine and ensure patients have access to some of the most innovative therapies and procedures.
At the latest Sunnybrook Speaker Series, experts shared their insights into how clinical trials work – and some key things that potential participants should know.
What is a clinical trial?
Clinical trials are research studies that test a medical, surgical or behavioural intervention in people. Interventions may include drugs, vaccines, devices or procedures.
Clinical trials have several phases during which they undergo rigorous checks and balances to ensure they are safe and effective. The goal is to determine whether a new treatment is more effective, or has less harmful side effects, than the current standard of care.
“All clinical trials happen in an important ethical and regulatory framework,” explains Dr. Nir Lipsman, a neurosurgeon and senior scientist with the Sunnybrook Research Institute.
Dr. Lipsman is also Director of the Harquail Centre for Neuromodulation and Co-Director of the Focused Ultrasound Centre of Excellence at Sunnybrook. He and his team have been involved in several world first clinical trials.
“The risks must always be outweighed by the benefits,” he says.
Who can participate?
Participation in clinical trials is strictly voluntary. It is also a deeply personal decision, says Maheleth Llinas, Manager of Sunnybrook’s Focused Ultrasound Centre for Clinical Research.
Llinas has years of deep experience coordinating clinical trials for various brain diseases and speaking with participants about why they choose to take part. She says some patients participate in the hopes of accessing cutting-edge treatments, while others are driven by an altruistic desire to help those with a similar condition or to help advance science.
Would-be participants should be aware that each trial has its own goal and eligibility criteria, Llinas says.
“It’s important for us to inform patients that when they’re being screened for a clinical study, they may undergo a series of assessments that determine their eligibility and whether they can proceed,” Llinas says.
In some cases, researchers might be looking for only healthy individuals to take part while other times they might want patients with disease to participate. Each study must also have a set of inclusion and exclusion criteria – characteristics such as age, gender and medical conditions — to ensure safety and reliable results.
What are some benefits and risks of taking part?
One possible benefit for patients taking part in clinical trials is having access to new treatments they might not otherwise, Llinas says.
Patients might also benefit from more focused care that allows them to learn about their condition in greater detail.
They might also feel good knowing they could be helping other people with similar diseases and advancing medical knowledge.
Risks include unknown interactions with the drug or medical device and the patient’s condition, or other side effects that might emerge as the trial goes on.
There is also the possibility that the intervention might not work.
Llinas says it’s important for patients to know about possible risks and benefits at the outset so they can make an informed decision about whether to take part in a clinical trial.
What happens if side effects occur?
Clinical trial participants should report any side effects they experience so they can be treated and monitored until the symptoms resolve.
If serious side effects occur, the intervention could be paused, reduced or discontinued.
Patients can withdraw from a clinical trial at any time.
“We want to assure patients that clinical trials are designed with safety as a top priority,” says Llinas. “However, they have the option to withdraw at any time and it will not be held against them. As researchers we really want to show empathy and understanding of patients’ concerns and fears and we want to provide them with as much support and information as possible.”
All clinical trials have safety assessments built in to reduce the impact and occurrence of side effects. If reviews of safety and efficacy find that the risks outweigh the benefits, then a decision is made to stop or modify the trial.
How do ethics help guide clinical trials?
At Sunnybrook, all human research activities must meet current scientific, regulatory and ethical standards.
This is monitored by Sunnybrook’s Research Ethics Board, which has a mandate to independently review, approve, reject, propose modifications to, put on hold or terminate clinical research.
Board Chair Dr. Brian Murray, who is also Head of the Division of Neurology, says there are three basic ethical principles that guide the Board’s decisions.
“One is respect for persons, so that means people have the right to be in the trial if they want and they have the right to have their information used or not,” Dr. Murray says.
Another guiding principle is concern for people’s welfare.
“Is the study safe and is this a good thing for participants to be involved in?” Dr. Murray says. “The safety of participants is paramount and above all other considerations.”
Finally, the Board also considers the question of justice. “Everybody should have access and ability to participate, and we should be looking after all people,” Dr. Murray explains.
Dr. Murray sums up the role of the Research Ethics Board by saying: “Our philosophy is that we are not here to protect participants from research — but rather we are here to protect patients for research.”
How can I learn more about clinical trials?
Anyone interested in learning more about taking part in a clinical trial should start by speaking with their primary care physician or specialist, says Dr. Lipsman.
“Speak to them and ask them: Is a clinical trial right for me and my particular condition, or the condition of my loved one?” he says.
Websites such as clinicaltrials.gov, which is run by the U.S. National Institutes of Health, is also a helpful resource because it lists all clinical trials that are running around the world and can be searched by location or hospital, Dr. Lipsman adds.
Sunnybrook’s website is another useful place to check, as well as disease-related organizations which often list clinical trials that are underway.
