What are inclusion and exclusion criteria?
Inclusion criteria are characteristics that a patient must have to participate in the trial. For example, a patient must have a confirmed diagnosis of breast cancer in order to be a candidate for a trial testing a drug’s effectiveness in treating breast cancer. Exclusion criteria are characteristics that a patient cannot have in order to participate in the trial. If a treatment requires that a patient have no history of hypertension, for example, then a participant with high blood pressure will not be eligible.
Inclusion and exclusion criteria are the rules used to determine who can and cannot participate in a specific clinical trial: Inclusion criteria are requirements that a person must meet to participate (such as CD4 cell count, viral load, age, or other laboratory values). Exclusion criteria are factors that prevent a person from participating either for his or her safety or to make it easier to understand the study results. For example, people might be excluded for having liver problems, or if they’ve already used a drug that is being studied. Women who are pregnant or breast-feeding are usually not allowed into a study because the medication may not be safe for the baby. Often there are separate studies for pregnant women. People are never excluded from studies because of race or income or the language they speak. In fact, HIV research programs try to enroll women and members of minority groups.
