Inclusion and exclusion criteria

Inclusion and exclusion criteria (pronunciation: in-kloo-zhun and eks-kloo-zhun kri-teer-ee-uh) are the factors that determine whether a person is eligible to participate in a clinical trial. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Etymology

The term "inclusion" comes from the Latin word "inclusio", meaning "a shutting in", while "exclusion" comes from the Latin word "exclusio", meaning "a shutting out". The term "criteria" is derived from the Greek word "kriterion", meaning "a means for judging".

Inclusion criteria

Inclusion criteria are the factors that allow someone to participate in a clinical trial. These criteria can include age, gender, type and stage of disease, treatment history, and other medical conditions. For example, a clinical trial studying a new drug for breast cancer might only include women who have not previously been treated for the disease.

Exclusion criteria

Exclusion criteria are the factors that prevent someone from participating in a clinical trial. These criteria can include certain medical conditions or medications that might make it unsafe for the person to participate in the trial. For example, a clinical trial studying a new drug for heart disease might exclude people who are currently taking certain other medications for the disease.

Related terms

Clinical trial: A research study that tests how well new medical approaches work in people.
Protocol: A detailed plan of a scientific or medical experiment, treatment, or procedure.
Eligibility criteria: The characteristics that must be met in order for an individual to participate in a clinical trial.