Is participating in a clinical trial in oncology an option for me?
Several steps are necessary for drug development.
In general, only a few people with cancer are recruited. They often suffer from advanced cancer and have generally received all available treatments that can be offered.
Phase 1 is used to determine whether an experimental treatment is safe for patients.
More specifically, it is about finding the highest dose of treatment that can be given without serious adverse reactions.
The goal might also be to:
Usually, a group of patients with the same type of cancer receives the experimental treatment.
Phase 2 is to test the efficacy of the product and determine the optimal dose.
In some studies, patients may be randomly assigned to different treatment groups. These groups may receive different doses or follow treatment in different ways to determine what is safest and most effective.
The goal might also be to:
Most Phase 3 clinical trials are conducted with a large number of patients who have the same type of cancer or, more rarely, with patients who have different types of cancer.
Phase 3 is used to compare the experimental treatment with the treatment usually used (called “reference treatment” or “standard treatment”).
Phase 3 trials are comparative trials.
Most of the time, two or more groups of patients are randomized: one will receive the reference treatment and the other the experimental treatment.
It is not the doctor who decides which of the treatments his/her patient will receive.
Key points of Phase 3 clinical trials:
Once a new treatment is approved and available to the entire population, its long-term effects are studied.
Many measures are in place to protect clinical trial participants. Every effort is made to minimize the risks. The following is a list of these safeguards to ensure the safety of clinical trial participants.
The research team must ensure compliance with good clinical practice during the course of the trial. These rules ensure the protection of the participants and the quality of the results of the test.
Researchers must conduct their clinical trials in accordance with the law. This includes allowing inspections to ensure compliance with regulatory requirements.
It allows to stop the test if the expected benefits are not there, or if the adverse effects are more harmful than expected.
The participant consent process includes the use of an informed consent form that clearly explains the clinical trial, benefits and anticipated risks and describes the rights and responsibilities of the participants.
The Research Ethics Board evaluates and authorizes clinical trials before they begin and continue until they are completed.
Experienced nurses from the Quebec Cancer Foundation and information specialists from the Canadian Cancer Society can help you: