Who can participate in clinical trials?
Where can I find the eligibility criteria for a clinical trial?
I am not sick, can I participate in a clinical trial too?
I am not eligible for a clinical trial. What should I do?
WHO CAN PARTICIPATE IN CLINICAL TRIALS?
Clinical trials enrol people with certain health problems as well as healthy volunteers, depending on what questions trials are designed to address and what kind of trial you are considering.
Where can I find the eligibility criteria for a clinical trial?
Eligibility or inclusion criteria are the characteristics of volunteer required for participation in a clinical trial, such as age, sex, stage of disease, previously used treatments, etc… Exclusion criteria are the characteristics that mean that someone should not participate in a particular clinical trial.
Depending on the type of trial and its phase, the research team will offer participating only to certain patients and will not enroll others.
Researchers use these criteria to identify the most appropriate participants, ensuring them potential benefits with minimum risks.
If you want to participate in a clinical trial you need to be elegible to do so. You can check the eligibility criteria in clinical trial registers, where this information is usually listed together with the title of the clinical trial, the location and some contact details, or you can ask for the study protocol directly from the research team if you are interested in volunteering.
I am not sick, can I participate in a clinical trial too?
You can decide to enrol in a clinical trial even if you are perfectly healthy. Several studies look for “normal volunteers” when developing new procedures, such as blood tests or scans, to assess what is “normal”, or for the approval of new drugs during phase 1 testing.
Important: studies involving healthy volunteers are not without risks. If you are considering enrolling to a clinical trial you will be given information that you need to fully understand before signing it. You also need to clarify the amount of required time and commitment and the level of discomfort you might experience.
I am not eligible for a clinical study, what should I do?
Although the offer of clinical trials is quite high, you might not be able to enrol because you do not satisfy the eligible criteria or the study has already enrolled all the patient needed.
In this case, you might ask your doctor to contact the research team asking for an eligibility waiver, a special exception for participating in the study, even though you do not strictly meet the requirements.
When a clinical trial is in its final phases, typically phase III, patients not enrolled in the study might access the new treatment – which has not yet been approved – as “expanded access” and “compassionate use”. Regulatory agencies have programs to allow patients with no other therapeutic options and in urgent need of treatment to access experimental treatments, which might be beneficial and have been monitored for potential risks.
