Clinical trials are scientific studies that determine whether a new treatment or approach to treatment is safe and effective in humans. They inform policymakers’ decision to approve new treatments for use in care settings, and/or to fund new treatments for public access.
By participating in a clinical trial, you can help improve healthcare and quality of life for yourself, your loved ones, and members of your community.
All research must follow internationally applicable rules and regulations that ensure it will produce high-quality evidence while protecting the rights of participants. Clinical trials have to follow stricter regulations related to safety measures and quality assurance than other types of research studies. One reason for this is that clinical trials test new medical treatments that may not be well-understood. The particular rules and regulations that apply to clinical trials allow the scientific community and policymakers to be surer of the effectiveness and safety of a new treatment. This is why clinical trials are considered the “gold standard” of scientific research, and policymakers consider them the most important type of scientific evidence for a treatment when considering whether to make the treatment accessible to the public.
Not all clinical trials are about drugs, medical devices or treatments. Clinical trials have helped develop screening processes and prevention methods to find diseases earlier or prevent them altogether. The value of lifestyle changes like exercise and diet are studied through clinical trials, and more often, people are surviving diseases like cancer due to clinical trials.
Many Canadians live with medical conditions or chronic illnesses. Some of them need medication or require many different treatment approaches, and others live with a medical condition for which there is no cure or effective treatment. To ensure medicine and treatments can advance to meet the needs of all Canadians, the involvement of Canadian volunteers in clinical trials is critical.
To learn more information about the rights of a research participant, please review the research participant bill of rights, a document collaboratively prepared by N2 and the Harvard Catalyst group. The document is available in both English and French.
• Clinical trials that test new medications are done in a series of steps called ”phases”.
• In total, there are four phases of a clinical trial. A new treatment must pass all phases in order to be implemented in healthcare settings.
• When the results of one phase are considered safe and effective, the trial moves on to the next phase, Information from each phase helps researchers design the phases that follow it.
Clinical trials take place once initial research is conducted to identify new, promising treatments. This initial research usually takes place in a laboratory, and includes animal subjects.
Once a new treatment has been identified, the clinical trial can enter Phase One.
Phase One of a clinical trial involves 20-80 participants. Individuals without a medical condition can usually participate in Phase 1 of a clinical trial. Healthy participants take a new treatment to determine:
• How much of the treatment is needed to address target symptoms of an illness.
• Possible side effects of the new treatment.
• The overall safety of the new treatment.
Phase Two of a clinical trial involves 100-300 participants. In this phase, researchers want to know if the treatment works as expected, if there are any later-onset side effects, and to further see if there are side effects, and determine what dose is most effective while still being safe.
Involves 1000-3000 people. Larger groups of volunteers are divided into two groups: one group receives the new treatment, and the other receives an existing treatment relevant for a target illness, or no treatment at all – this group is called the “control group.” Both groups are then monitored to continue observing side effects and to see how well a treatment works in the long-term, how long its effects last, and how it compares to current treatments or a placebo.
Involves a large population. After successful completion of all phases, once the treatment is on the market, the long- term effects and safety are studied and determine if existing therapies should be replaced.
Search for new ways to prevent illness.
Help detect diseases or conditions.
Test new types of treatments.
Depending on the research that is being done, clinical trials may happen in many different places, including:
Doctor’s offices, hospitals, clinics, community nursing stations, etc.
Usually universities or medical schools
You can participate in some clinical trials from the comfort of your own home