In part 1 of our blog series on clinical trials, we explained what clinical trials are, why you should participate in them and how to get more information about participating. You may now be familiar with clinical trials but still hesitant about enrolling in one because of certain concerns that you may have. These concerns are valid as many breast cancer patients have these same concerns. However, some of these concerns about clinical trials are ill-informed. In part 2 of our blog series on clinical trials, we debunk some of the most common myths surrounding clinical trials. We hope that this will provide you with some fact-based information to make a more informed decision about whether or not clinical trials are right for you.
Myth #1:
Once I begin a clinical trial I have to stay on it until the end.
Fact:
Participating in a clinical trial requires informed consent. That means that you will be given information about the treatment being studied and are kept informed during the study and once it is completed.1 While you must sign a consent form to indicate you are aware of the details of the study and so that you can participate in the study, you can decide to leave at any time, for any reason. Those in charge of the study will make sure that you can safely stop the study and you will then continue your regular treatment with your doctor or healthcare provider.2
Myth #2:
Clinical trials are a last resort for when I’ve run out of treatment options.
Fact:
Clinical trials are not just for those who feel like they have exhausted all other options. Instead, clinical trials can provide you with more and potentially better treatment than what is considered standard. Clinical trials also have very strict guidelines about who can participate; sometimes not receiving any other treatment is an eligibility criterion.
Myth #3:
I’ll be treated like a guinea pig or a lab rat.
Fact:
Clinical trials in Canada must follow strict guidelines from Health Canada to make sure that patients are protected.3 Treatments being tested in clinical trials also undergo a preclinical trial (which can take years) where they are tested on cells in petri dishes or on animals to determine their safety, before they are tested on people.4 You must also provide informed consent, meaning that you will be given information before, during and after clinical trials.5 In addition to this, the quality of care is sometimes better than the standard of care. This is because patients in clinical trials are closely monitored and attended to so any issues that you have will be addressed.6
Myth #4:
If I’m in the placebo group I won’t be receiving any treatment.
Fact:
Being in the placebo group means that you are not receiving the specific treatment that is being tested. In most clinical trials, you are randomly placed in either the placebo group, also called the control group, or the experimental group, which is the group that gets the treatment that is being tested. If you are randomly assigned to the placebo group, you will simply be given the current standard of care.7 That means that regardless of what group you are placed in, you will always be getting treated.
Myth #5:
My doctor will tell me which clinical trial to participate in.
Fact:
There are hundreds of clinical trials authorized by Health Canada every year. Your doctor or healthcare provider may be very familiar with the trials that are offered in the centre that they work in; however, there may be trials that aren’t offered in the centre that they work in that may be beneficial for you. Some patients are also able and willing to travel to other cancer centres, cities and provinces to access a clinical trial; conducting some of your own research will allow you to understand if there are other trials outside of the centre that you’re currently receiving treatment at that may be beneficial for you. You can then discuss with your healthcare team whether or not these may be beneficial and how to enroll in trials outside of your current treatment centre. You can visit Clinical Trials Ontario or ClinicalTrials.gov to search which Canadian clinical trials you may be able to participate in.
Your doctor and/or healthcare provider are there to help you make an informed decision about whether (and which) clinical trial you should participate in. This means that they cannot force you to enroll in a clinical trial nor can they stop you from enrolling in a clinical trial.
Myth #6:
Participating in a clinical trial is not safe.
Fact:
While clinical trials come with a unique set of risks, as with anything else, clinical trials are safe. The treatment in question first goes through years of testing in a preclinical trial that uses non-human subjects; the treatment is only tested in clinical trials on humans when it has been deemed safe to do so.8 The procedure to study a new treatment on humans is regulated by Health Canada and part of this process includes passing ethical standards judged via a research and ethics board.9 Those conducting clinical trials must submit a protocol, which is a detailed plan of what the clinical trial will consist of. Furthermore, if the clinical trial is not going according to plan or any safety issues come up, they will stop the testing.10
Researchers do not only submit documentation to the government about their study but to patients as well. Patients receive informed consent with information about the study such as how long the study should take and potential side effects.11 Signing the consent form indicates that you have read it, not that you will stay in the study to the end; you can stop a clinical trial whenever you want and for whatever reason.12 Before signing a consent form, feel free to ask questions about any concerns you may have.
Myth #7:
I can’t participate in a clinical trial because of the stage of my cancer.
Fact:
Each clinical trial has its own list of eligibility criteria. This can be based on age, family history, medical history etc. Therefore, clinical trials are available for various types and stages of breast cancer.13 The best way to know if there is a clinical trial for your situation is to check with your doctor and/or healthcare provider and to also conduct research on your own starting with visiting Clinical Trials Ontario or ClinicalTrials.gov.
Photo by Chang Duong on Unsplash
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