Frequently Asked Questions
about clinical research
Many questions arise when considering participation in a clinical trial. Here is a short list of the most frequently asked questions. Q-CROC thanks the members of the Patient Partners Committee of the Quebec Cancer Consortium for their contribution to the development of this FAQ.
A clinical trial in oncology is a research project on cancer. It may also be called a clinical study. A clinical trial is used to test experimental cancer treatments or experimental approaches to prevent or diagnose cancer (e.g., drugs, medical devices or other medical interventions) in humans.
An experimental treatment may eventually become a “standard” treatment (available to the general population) if the results of clinical trials show that it is safe and effective.
You cannot be enrolled in a clinical trial without consenting voluntarily. After having received all the information, you’re the one who decides in
all freedom if you want to participate.
Although a large proportion of clinical trials are conducted in Montreal and Quebec City, several trials are conducted outside of these major centers. Clinical trials in oncology are taking place in Sherbrooke, Gatineau, Laval, Longueuil, Saint-Jérôme, Trois-Rivières, Lévis, Chicoutimi and Rimouski.
Since you will be making the decision, consider the pros and cons. You will receive a document that explains the clinical trial in detail: the “Information and Consent Form”. Read it carefully. Make sure you are comfortable with all aspects of the trial and what is expected of you as a participant, such as:
-the reason for testing the experimental intervention
-the duration of the trial and its various stages
-the number and frequency of hospital visits
-the types of examinations or tests and their frequency
-the experimental treatment you may receive, its risks and possible benefits
-whether you will be required to keep a diary at home
-whether a placebo (inactive substance) will be used
The research staff is there to help you understand all this information. Ask as many questions as you want. If – and only if – you are comfortable with everything, you can sign up to participate in the clinical trial.
The minimum treatment that you will ever receive is the current standard treatment approved for your condition. If there are no standard treatment for your condition, you may receive only a placebo. You will be informed by your study doctor if receiving a placebo is a possibility in the context of a clinical trial.
You may need to go to the hospital more often, so you may have extra expenses, such as transportation and parking expenses. Some clinical trials reimburse these costs. Before the start of the trial, ask your research team if these costs are covered.
Yes. You can always drop out of a clinical trial at any time, for any reason, without jeopardizing the quality of medical care you will be receiving.
To participate in a clinical trial, you must meet precise criteria that are specified in the study protocol, such as:
– type of cancer
– cancer stage
-whether it’s a first occurrence or a relapse
– general health status, apart from cancer
The investigator and his or her team are responsible for assessing whether you meet these criteria.