Frequently Asked Questions
Are clinical trials safe?
Patients often enquire about the risks of participating in a clinical trial. There are numerous protocols in place to minimize potential risks to patients including the informed consent process. The strict regulation of clinical trials helps ensure that the balance between medical progress and patient safety is maintained. Phase I, II and III clinical trials are monitored by: 1) Health Canada; 2) Ethics committees at each of the participating hospitals or clinics; and sometimes also by the 3) “Data Safety Monitoring Board”, an independent group of experts.
Occasionally, a clinical trial is halted because of safety concerns. Generally speaking, the benefits of participating in a clinical trial outweigh the risks. Before agreeing to participate, all patients must learn the possible risks of entering a trial and what other options are available to them. Potential participation should be discussed in depth with their physician and healthcare team.
Are clinical trials only for people who have run out of options?
Many trials are available for patients at every stage of their disease, including the first therapy (first-line) after diagnosis. This offers the opportunity to deliver the newest therapies to patients early on in their treatment journey, as well as to patients whose therapy is no longer effective. It is important to note that researchers don’t know if the new treatment will be better than the current standard of care. What researchers do know is that some clinical trials will result in better future treatments for patients.
I’m worried that I will be given placebo or no treatment.
This is a common concern and is also a common misconception. In myeloma studies, it is unethical to administer a placebo or no treatment. At the very least, patients are given the approved standard of care treatment.
For example, if the current standard of care is “A+B”, and the new agent is being studied is “C”, people in the experimental arm receive “C” and people in the control arm receive “A+B”. In myeloma, the new agent is often studied in combination with the current standard of care. In that case, people in the experimental arm receive “A+B+C” and people in the control arm receive:
“A+B” if the trial is open label
“A+B + Placebo” if the trial is blinded
In some cases, the control arm group has a “cross-over” option. This means if a patient is receiving the standard of care treatment (A+B), but is no longer responding to treatment, they have the option to “cross-over” to the experimental arm and receive the new treatment (A+B+C).
What does eligibility criteria mean?
Not all clinical trials are right for every patient. There are certain conditions and requirements that patients must meet in order to be able to participate in a particular study. This allows researchers to work with consistent data when answering the question being asked in the study. Examples of eligibility may include: age, general well-being (performance status), type and stage of cancer, medical tests, laboratory results, other illnesses and past treatments.
“Inclusion” criteria determine who is eligible to participate in the trial and “exclusion” criteria determine if a patient is not eligible for the study. Inclusion and exclusion criteria are important for obtaining the most accurate results possible from the study.