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I was invited to participate in a research protocol. What is involved?

– Dr. André Robidoux, founder of the Clinical Breast Cancer Research Centre at Hôtel-Dieu Hospital in Montréal, demystifies the question.**

What is a Clinical Trial?

Since the 1970s, much progress has been made in improving the standard treatment for breast cancer, thanks, to a large extent, to the participation of many affected women in clinical studies carried out through a rigorous, scientific methodology:

If we can see that today’s breast cancer treatments are based on a well-established protocol, we should remember that none of this medical progress would have been possible without the selfless sacrifice of women patients from Quebec and other parts of the world who participated in the many research protocols that allowed us to develop the treatments we have today.

Forty years ago, when a woman consulted her doctor about a large, suspicious lump in her breast, she was placed under general anesthesia to have a biopsy and, if a cancerous tumour was found, she immediately underwent a radical mastectomy and had the lymph nodes in her underarm removed. Since then, using the scientific method to find solutions to problems has led to enormous progress.

This method consists in making assumptions and then testing them through a type of study called a “prospective randomized trial”. Two groups of patients are formed randomly from the pool of participants: an experimental group (patients who follow the new treatment being analyzed) and a control group (patients who follow the current standard treatment). Results for both groups are then compared to assess the effectiveness of the new treatment or care protocol. Every prospective study tests a new hypothesis, building on the results of previous studies.

These studies have led to the development of today’s standard treatment, made up of six components: surgery, chemotherapy, radiotherapy, hormonotherapy, targeted therapy and support therapy.

Thanks to the various studies carried out over the years, we have now reached the era of personalized medicine. However, although we are more competent than ever at treating breast cancer, we still have a long way to go before we can fully understand this disease.

Benefits and Drawbacks of Participating in a Clinical Study

According to Dr. Robidoux, patients agree to participate in a research protocol for several reasons:

  • altruism: being suddenly overwhelmed with anxiety for not knowing whether they’ll survive, women want to help researchers make progress so that their children and future generations can benefit from the scientific advances;
  • a feeling of gratitude towards women who participated in previous studies;
  • the chance to benefit from the most advanced treatments;
  • the possibility of receiving better medical care: at the same stage of the disease, women who participate in research protocols have a higher survival rate than those who don’t. They receive treatment in leading-edge facilities, are monitored very closely by medical teams, undergo numerous examinations on a regular basis, and are closely followed by the entire international community of breast cancer experts when problems arise.

That being said, participation does require a great deal of involvement and altruism can reach its limits. Moreover, participating in a research program does not guarantee that the patient will receive a revolutionary experimental treatment since participants are usually assigned randomly to either the experimental or the control group.

Dr. Robidoux reminds that a clinical trial is scientifically valid only if the research protocol is followed from the beginning until the end of the treatment. Thus, when a woman agrees to join a research program, she becomes subject to a fairly strict monitoring regimen. For example, she may have to go to the hospital every week, have regular check ups, or keep a daily log of when she takes her medication.

In light of this, patients usually have mixed feelings: on the one hand they are satisfied and reassured to be in such a solid and rigorous environment, to know that a research nurse is at their disposal to answer all kinds of questions about their health, and to be in the care of a leading-edge medical team; on the other hand, it’s difficult to spend entire months in a rigorous medical environment that restrains their freedom. That being said, if a patient ever feels the need to leave the research protocol, she can do so at any time; a provision for this is included in the consent form that was signed by both patient and doctor beforehand.

How to Join a Research Protocol

As we make advancements in research and acquire knowledge on breast cancer, we’re faced with new scientific questions. If a patient suffers from a specific issue that is being analyzed in a prospective study, joining this study often proves to be her best treatment option.

Whether the research is ongoing or has just begun, patients with issues related to the subject being studied are evaluated to determine whether they meet the various selection criteria laid out in the protocol. This doesn’t always turn out to be the case.

Once the doctor and the research team confirm that patients meet the recruitment criteria, they are asked to join the research protocol that deals with their issue. They can then either accept or refuse to participate. It’s only once patients are fully informed of the risks and benefits of joining a trial, and after they’ve had from a few days to several weeks to think it over that they can make a commitment by signing a consent form.

To learn more about clinical trials currently in progress, visit cancerview.ca.

** In his new book, Les raisons d’espérer, Dr. André Robidoux demystifies clinical research and explains every aspect of breast cancer. He covers a wide range of topics related to clinical research, including information on his 30-year career as a surgical oncologist, the different types of breast cancer, breast cancer treatments through the centuries, current treatments, prospective randomized trials, patient-based clinical research and the future of treatment and research.

With his permission, we have used several excerpts from his book (our translation) to write this column.

Les raisons d’espérer is published by Les Presses de l’Université de Montréal and is available online and in bookstores. The QBCF is proud to be a participant of this important project.