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The Voice of People With Breast Cancer


Our Voices Blog

Clinical Trials – 101

Clinical trials play a big role in the discovery of new treatments for cancer. They help to determine the safety and effectiveness of potential new treatments. For metastatic patients, they can also potentially offer additional treatment options after the cancer has grown resistant to the standards of care.

Any cancer drug available for use in Canada has been tested through a clinical trial program, starting with laboratory testing and moving on to phases with human subjects. There are three phases in clinical trials. Phase 1 and phase 2 trials generally have a smaller number of participants and researchers are trying to understand whether a new treatment is effective and safe, what the side effects may be, and what the best dose is for that treatment. Phase 3 trials can involve as many as 3000 people and are usually offered in several cities across the country. At this point, the medication has shown clinical benefit and the researchers are comparing it to the current standard of care to see what provides the most benefit and tolerable side effects.

Currently, many of the clinical trials that are available in Canada are phase 3 trials. Trial participants will be randomly placed into one of two groups: the one receiving the study medication or the one receiving an alternate medication (known as the control group). If you are in the control group you can either be given the current standard of care or a placebo if there is no current standard. For metastatic trials, however, the participants will never be given a placebo so they will never be deprived of treatment for their cancer. Neither the researchers nor the participants will know what treatment is being administered. This helps to avoid any potential for bias in both the administration and reporting of the trial.

Every clinical trial will have its own set of eligibility criteria to determine who is suitable to participate. Criteria can include age, sex, type and stage of cancer, overall health, and if you’ve received previous treatment.  The eligibility may seem restrictive but it does help to ensure a better understanding of how and for whom the treatment will benefit.

While you have the potential to benefit from new medications during a clinical trial there can be some risk as well. It may turn out that the new medication does not work as anticipated or does not work as well as the current standards of care. Unknown and potentially adverse side effects are also a risk when participating in a clinical trial. You will be closely monitored by doctors who will give you as much information as they can about the potential side effects before you begin. They will also help you manage the side effects if necessary.  You can always choose to leave a clinical trial if you find it is not right for you.

One of the benefits that patients often find with clinical trials, aside from possibly accessing a more effective treatment, is that you’re followed more closely for years after the trial. Some patients find it reassuring to know that they are still being monitored by a specialized oncology team even after they are done that particular treatment.

If you’re interested in participating in a clinical trial, download our list of questions to ask your healthcare team here.

Photo by Marcelo Leal on Unsplash

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