The second installment in our series looks at the structures in place to ensure clinical trials are safe for participants.

The first part of our Let’s talk about clinical trials series explored why cancer clinical trials are important to research, and how cancer patients can benefit from participating.

In this next installment, we’re talking about the safety and wellbeing of the people who participate in clinical trials.

We asked Natascha Kozlowski, Executive Director of the Ontario Cancer Research Ethics Board (OCREB), about how clinical trials, and the systems around them, protect the health and safety of trial participants.

What potential advantages are there for patients interested in participating in a clinical trial?

Clinical trials provide options for patients, and the potential to access the latest therapies years before they would otherwise be available. There are no placebos in cancer clinical trials. All participants receive, at minimum, the standard of care they would receive as part of their regular cancer treatment. And by participating, they are helping develop even better methods to prevent, diagnose and treat cancer that will benefit future generations.

What systems are in place to ensure that clinical trial participants are protected?

Clinical trials undergo a lot of scrutiny before being launched. For one, trial proposals are often peer reviewed to make sure their design and procedures are safe and scientifically rigorous. They also undergo a detailed review by regulatory bodies like Health Canada to ensure there is solid evidence behind the device or medication being tested. And, of course, clinical trials must be reviewed by a research ethics board to ensure any potential risks or burdens for participants are minimized. So, it’s a three-pronged approach, and it’s quite robust.

Tell us more about how research ethics boards ensure participant safety.

Research ethics boards are independent committees of experts that thoroughly review clinical trials with the rights and welfare of participants in mind.

They evaluate whether the research team has the credentials to safely perform a trial, whether there is any conflict of interest that could compromise patient safety, and whether any part of the trial design could pose undue risk for participants.

Risk mitigation is extremely important. The potential benefits of a trial must outweigh any potential risks for participants, and any risks must be clearly outlined in the consent process so that participants can make informed decisions.

Clinical trials can’t move forward unless they are approved by a research ethics board, and there are several conditions that must be met for that to happen.

What advantages are there in having a cancer-specific research ethics board like OCREB?

As a specialized research ethics board, OCREB only reviews cancer research studies. Our committee is comprised of world-class oncologists, statisticians, pathologists, pharmacists, research staff, scientists, ethicists, legal and privacy experts, cancer patients and community members who understand the complexities of cancer research.

That allows OCREB to streamline the review process, with fewer questions for the research team, and usually a faster turnaround time so that promising, safe clinical trials can proceed more quickly.

Why should cancer patients ask their doctor about clinical trials?

Cancer treatment is a very personal decision. Asking about clinical trials can add interesting new options to that decision — for that patient and for others in the future.

While clinical trials may not be an option for every cancer patient, asking their doctor about trials allows patients to take a more active role in their health. It could also be hugely beneficial for others affected by cancer.

Right now, only a fraction of adult cancer patients participate in clinical trials. If more people participate, research and care will advance at a faster rate, and we can take even bigger steps toward solving cancer.