The requirements that must be met for a person to be included in a clinical trial. These requirements help ensure that the treatment is tested in an appropriate patient population and that participants in a trial are like each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors.
Eligibility criteria are broken down into exclusion criteria and inclusion criteria.
Exclusion criteria – the characteristics that prevent/disqualify a person from taking part in a study. This could include being pregnant, having other serious health conditions or having a weakened immune system.
Inclusion criteria – the characteristics that a person must have to be eligible to take part in a study. This could include having a specific type and/or stage of cancer, being within a certain age range or having a specific biomarker.