Today, Canadians are living longer than ever before, thanks in part to treatments for illnesses like cancer. These medical advances wouldn’t be possible without the millions of patients who have participated in clinical trials — studies that determine whether or not a new medicine, diagnostic test, or procedure is safe and effective to use.
Clinical trials provide early access to treatments, contribute to medical knowledge about a condition, help guide future research, and have the potential to impact how people with the same condition are treated in the future. While Canada is a leader in clinical research, Canadians have many questions about this topic and hold many misconceptions that prevent them from participating in clinical trials. We recognize that — for many people — the decision to participate in a clinical trial is a daunting one, so we thought we’d take this opportunity to debunk a few common clinical trial myths.
Myth #1: Clinical trial participants are human guinea pigs
Before medicines can be approved for use, they must undergo extensive clinical research to ensure they are safe and effective. Each trial is conducted according to a carefully designed plan, known as a protocol, that safeguards you and other participants, and seeks to answer very specific research questions.
Investigational medicines are researched extensively in a laboratory before they are ready for clinical trials with human volunteers. Strict eligibility criteria based on individual characteristics prevent people that would not receive benefit or who may be at risk of developing adverse side effects from participating in the trial. The criteria also ensure that the outcome is the result of the new treatment or procedure and not just chance. Although researchers cannot guarantee outcomes, a patient’s safety is always the top priority.
Clinical research has enforced oversight, and patients also have rights that help protect them. Before participating, you are given in-depth information about the study — the purpose, length, procedures that will be completed during the study, any predictable risks or potential benefits, how information is collected and shared, and your rights regarding participation. In order to be admitted into the trial, you must understand and agree to all of these details through a process known as “informed consent.” The process of informed consent continues throughout the study and you may choose to withdraw from the trial at any time.
In addition to the built-in oversight, government and international regulations are also in place to make sure that research involving people is done according to strict scientific and ethical guidelines. Clinical trial protocols are reviewed by a panel at the hospital, clinic or university before the trial begins. The panel, called a Research Ethics Board (REB) or Institutional Review Board (IRB), includes doctors, scientists and members of the general public. REBs help to protect the people who take part in a clinical trial. They also ensure that the study is well designed, legal and ethical, and that it does not involve unnecessary risks. In addition, Health Canada must approve all clinical trials that assess the safety and efficacy of an investigational molecule (a medicine not approved for use in Canada).
Myth #2: Your doctor will tell you if there’s a clinical trial that might benefit you
While your doctor may be able to direct you to relevant trials, they may not be aware of all of the options available to you. Health Canada authorizes approximately 900 clinical trials every year, so there are numerous trials taking place in a particular disease area at any given time. If you are interested in looking for information about available trials, the U.S. National Library of Medicine site ClinicalTrials.gov, Health Canada’s Clinical Trials Database, CanadianCancerTrials.ca, and patient organizations are excellent resources for Canadians.
Before deciding whether a trial is an option for you, or someone you care about, it’s important to learn everything you can. While they may be a good choice for some people, clinical trials may not be the best option for everyone. You should always talk to your doctor or healthcare professional who will help you make the right choice for you.
Myth #3: Every clinical trial uses a placebo as a comparison
The comparison treatment you receive, whether placebo (an intervention with no active ingredients or therapeutic effect) or an existing medicine, depends on the type of trial. Clinical trials may compare a new therapy to one that is already available, to a placebo that contains no active ingredients, or to no medicine at all. The comparison group that does not receive the investigational medicine is known as the “control” group and they are used to determine how effective the new intervention is when compared to current practice.
In studies where there is no available treatment, or where the condition isn’t life-threatening or debilitating, the control group will receive a placebo. While many clinical studies today don’t give patients a placebo, informed consents are very clear, and you would be made aware before enrolling in a clinical trial if there was a possibility that you might receive a placebo. In the case of life-threatening or debilitating conditions, such as cancer, patients either receive the current standard of care or the investigational treatment — i.e., they do not receive a placebo. Placebo is only used where a standard of care has not been established or there is no existing treatment for the disease. This approach allows researchers to determine the potential impact of a new intervention without withholding treatment.
Myth #4: Being in a clinical trial won’t help you
Clinical trials can give patients access to the latest medicines and procedures. Studies show that patients who participate in clinical trials have outcomes at least as good, if not better, than the general patient population. In some cases, clinical trials are a last resort — there are no other treatments, or other interventions haven’t worked or have stopped working. But many times they involve an addition or adjustment to a standard treatment plan that may provide patients with a better quality of life.
Clinical trials may be available for patients at every stage of their disease, including newly diagnosed patients, as well as those who have exhausted some or all of the available treatment options. Before making any decisions about your treatment options, it’s important to talk to your doctor.
Myth #5: If you sign up for a clinical trial, you lose control of your personal health information
Sharing clinical data helps physicians, patients and healthcare providers make informed treatment decisions. Data sharing can also enable researchers to more easily build on research, with the hope of advancing scientific progress. While sharing is important, protecting the privacy of all individuals participating in clinical trials and ensuring clinical trial data is shared in a responsible manner that safeguards personal information is the most important consideration for companies like ours.
When you join a clinical trial you are required to provide a large amount of your personal health information such as weight, blood pressure, medical history, and sometimes even genetic information. As part of the informed consent process, you will receive information about all of the personal details that will be collected, how it will be used and shared, and how it will be protected. Generally, the clinical information gathered is separated from identifiers specific to the participant (such as individual names) because it’s not necessary for statistical analyses. When this data is accessed by a researcher, formal data agreements include conditions protecting the confidentiality of individual participant data.
Canada, like most other countries, has legislation that protects your privacy, including the Personal Information Protection and Electronic Documents Act (PIPEDA), which puts you in control of your personal information by prohibiting anyone from collecting, using, or disclosing your genetic information without your consent. In addition, each province has its own privacy legislation and each of these jurisdictions has a Privacy Commissioner who enforces privacy laws.
Clinical trials are an important step in discovering new treatments, as well as new ways to detect, diagnose, and reduce the risk of disease. Participating patients receive specialized care from leaders in their field, and trial costs, including patient care and the price of investigational, as well as comparator treatments are covered, resulting in cost savings for the healthcare system. In addition, clinical trials are essential to ensuring the healthcare sustainability as they offer high-quality data to help physicians make informed decisions, including which treatments will be approved and funded.
For more information about clinical trials or to find a Roche-sponsored study, speak with your doctor or visit clinicaltrials.gov, Health Canada’s Clinical Trials Database, or CanadianCancerTrials.ca.
November 5, 2018