Understanding clinical trial eligibility
All cancer clinical trials have rules that determine who can participate – these are called clinical trial eligibility criteria. These rules outline features that all participants must have in common or share in order to participate. Structured eligibility criteria varies depending on what is being tested but may include things like:
- age
- gender
- cancer type
- stage of cancer
- symptoms or side effects
- time since diagnosis
Exclusion and inclusion criteria (eligibility criteria) for clinical trials exist to help the researchers. These criteria identify that the results of the trial were due to the clinical oncology treatment being tested and not some other factor.
They also help protect the safety of the people participating in the trial. The criteria are unique to each trial and often very long and complex. Your doctor is the best person to help you decide whether or not you meet the eligibility criteria for a particular clinical trial.
Other eligibility considerations
Contraception
Women of childbearing age and ability are often requested to utilise effective means of contraception. Men are also often required to utilise contraception in clinical trials for cancer research.
Psychiatric history
Your past mental health and psychiatric history may impact on your ability to participate in a cancer clinical trial. This can be due to the legal requirements of a clinical trial, which require you to provide informed consent; it is also about protecting the patient’s safety in a trial.
Minimum time periods since surgery, radiation therapy, and certain drugs
Past treatments may impact your ability to join particular cancer clinical trials. The inclusion and exclusion criteria will be very specific about which types of surgery, radiotherapy, or drug treatment you may have had and the time that needs to have passed since you have had these treatments.
Allergies
Some allergies may exclude you from participating in some clinical trials. This is to ensure the safety of all patients participating in the clinical trial. If you have allergies of any kind, you should speak with your doctor.
Genetic testing
Some clinical trials will require you to undergo genetic testing. You should discuss what this means with your doctor and how this might impact you and your family.
Biospecimens and biopsy availability
Some clinical trials will want to use a sample of your cancer for scientific testing. This is so the researcher can understand your cancer better. They may ask to access a sample that has already been taken through a procedure (e.g. biopsy, blood test, FNA etc.) or request that you undergo a new one.
Ability to read, write and understand English
Many clinical trials will have a requirement that you can read, write and understand English before joining a trial. This is often due to clinical trial practicalities including the legal requirements and resources available to clinical trial staff for translation services. It also helps protect the safety of the trial participants, allowing trial staff and patients to communicate clearly.