Written by Alexis Dobranowski, Communications Advisor at Sunnybrook.
How you are diagnosed with an illness and treated for that illness is based on years of research and evidence. That evidence is constantly being revisited by researchers who are searching for the best and safest ways to find, diagnose and treat diseases.
While most research begins in the lab, there are many more steps before the research gets to people.
A clinical trial is a research study that involves people. After showing promise in a lab, a clinical trial is the next step. Clinical trials look at the effect of a medical action on people's health and often compare one treatment to another. The studies often look at how well new treatments work and how safe they are to administer.
Sasha Manohar, clinical research associate, and Maurice Zakhem, data manager, both in the Odette Cancer Centre Clinical Research Program, gave us a little crash-course in clinical trials. If you have questions about clinical trials, talk to your doctor.
How is a clinical trial different from other research?
Clinical trials, unlike other research, always involve humans. The studies are thoroughly reviewed by trained staff who decide whether or not the research is safe and ethical to perform on humans. These studies are performed with patient safety and confidentiality as a priority and you are always given a choice whether or not to participate.
Who is involved in a clinical trial?
A whole team is involved in running a clinical trial at a hospital. All clinical trials are supervised by a doctor at your hospital who either treats you or is part of a team that is involved in your care. This doctor is considered a principal investigator (PI) and their colleagues are called co-investigators. Clinical Research Associates (CRAs) or Clinical Research Nurses also help guide you through your participation in the study. Depending on the type of clinical trial, you may also have contact with hospital staff from medical imaging, phlebotomy (the blood lab), and other departments.
Who can be in trials?
Each clinical trial has requirements about who can participate. These are called eligibility criteria. Think of it like that phrase "That's comparing apples to oranges!". Clinical trials need to compare apples with apples (Sorry to compare people to fruit!) The researchers need make sure all participants on the trial are similar in key ways so they can be confident the results of the trial come from the treatment being studied and not from other factors. So, if the trial is looking at a new chemotherapy drug on breast cancer, the researchers may want to be sure the participants have the same type and stage of cancer, have all had the same amount of radiation and are in a particular age range.
These eligibility criteria commonly include the type or stage of cancer, previous treatment for the cancer and the patient's overall health.
How do you get into a trial?
To become a part of a clinical trial, speak with your doctor. Your doctor is the first link to participating in a clinical trial. Your doctor can see if you meet any of the eligibility criteria for clinical trials being conducted at hospitals near you. If your doctor thinks you might be suitable, he or she will give you an informed consent form that tells you more about the study. You'll also meet with a clinical research associate to discuss the trial further, ask any questions you have and decide whether to participate or not.
How long do trials take?
The length of time you participate in a clinical trial can have a huge range, from a few months to a few years to even longer. It all depends on what questions the trial is trying to answer. It's common for clinical trials to follow patients for a long time after they have finished treatment to look for long-term outcomes such as side effects, the cancer worsening or returning. Ask your doctor how long you have to participate if you are thinking of taking part in a clinical trial. You can also ask the research staff when you may know the results of the trial.
Do they always work as a better treatment?
By participating in a clinical trial, you may be among the first to receive a new treatment that is otherwise not available. But remember -- there are both risks and benefits to taking part in a clinical trial. While you may be among the first to benefit from a new treatment, there is also the risk that the new treatment isn't better than the current standard of care. As with all cancer treatments, a new treatment may not benefit all participants. It is important to discuss possible risks and benefits with your doctor as well as those close to you.
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