Clinical trials: their myths and the different drug approval processes in Canada
Despite the fact that Canada is one of the most popular destinations for clinical trials and drug approvals, there are still many misconceptions about the subject. We want to take the opportunity of this blog to present you with an exhaustive list of the various common myths about clinical trials.
Myth 1: Clinical trial participants are guinea pigs
One of the most common questions asked by volunteers curious about clinical trials is “will I be a guinea pig?”.
We will answer this question and debunk the myths surrounding it. First and foremost, it is essential to understand that before a drug is approved, it must undergo a multitude of evaluations to validate its safety and efficacy. As such, each clinical trial is designed according to a rigorous plan and closely monitored to ensure the safety of all participants.
Before the study, clinical trial participants are provided with all the necessary information to ensure that they have a precise picture of each clinical trial stage and what to expect. The information includes the aim, period, potential risks, as well as potential benefits to participants, etc. These different terms must be fully understood and accepted by the participants. The individuals in charge of the study remain available at all times to guide and answer any inquiries related to the study in question.
In addition to these various procedures and oversight mechanisms, the entities conducting the study must comply with governmental and international regulations to ensure that the research is executed according to high scientific and ethical standards.
Myth 2: Clinical trials are only recommended by a doctor
Your doctor is indeed the person you can rely on to refer you to clinical trials relevant to your condition. However, he or she may not be aware of all the trials that are being conducted, as there are over 900 clinical trials approved by Health Canada in Canada each year.
Therefore, if you would like to learn more about the different clinical trials underway or in the recruitment phase, we invite you to visit ClinicalTrials.gov or consult Health Canada’s clinical trials database.
Please feel free to email or sign up for our newsletter and read about our ongoing studies.
We encourage all of our participants to always learn as much as possible about the study in which they are considering partaking and to consult with their physician or a health care professional to make an informed decision.
Myth 3: Clinical trials provide no benefit to the participant
Clinical trials provide patients/participants with access to new and innovative treatments. It is true that for some patients, clinical trials also represent the last resort when existing treatments are ineffective or have become or are completely unavailable.
Clinical trials, therefore, aim to provide an alternative solution and thus improve the quality of life of patients.
Myth 4: Recruiting in Canada is a risky business
Recruitment and retention of participants are not different from elsewhere. In fact, according to the Canadian Coordinating Centre for Clinical Trials (CCCEC), the average time from trial initiation to the first participant visit is three months, with over 98% of subjects enrolling.
In addition, Canada offers a wide variety of patients from around the world, providing researchers with a broad range of participants.
Myth 5: When starting a clinical trial, it is necessary to complete it
As mentioned earlier, all participants receive all the necessary information before commencing the study. This implies that the sponsor will clarify that even if you sign the consent form, you have the right to cease the trial at any time. There will be no repercussions for quitting the trial. In addition, the sponsor will take all necessary steps to safely stop the treatment and allow you to resume your standard treatment.
Myth 6: The risks associated with a clinical trial are significant
Clinical trials are indeed associated with risks; however, they remain safe. To ensure a study is safe, several steps are taken into account.
A preclinical trial involving non-human subjects is conducted for years on the evaluated treatment. Therefore, if the treatment is not deemed safe, it will not be tested on humans.
Adherence to ethical standards as assessed by a research ethics board is necessary to proceed with the study of a new treatment in humans.
The sponsor of the clinical trial must submit a protocol consisting of a detailed plan of the nature of the trial.
In addition, all documentation regarding the study must be provided to the government and patients. This documentation includes information about the study, such as the duration and possible side effects. For you information, signing the consent form does not commit you to continue the clinical trial until termination. Therefore, you have the right to end you participation at any time.
Myth 7: Once the clinical trial is over, I will no longer have access to the treatment
If the treatment in the clinical trial was successful for you, it may be possible to participate in an “extension group” offered by the pharmaceutical company or trial sponsor. This opportunity allows patients to continue the experimental treatment. However, if no “extension group” is created, the trial participants may apply to have the drug granted for compassionate use for the client.