Inclusion/Exclusion criteria

The inclusion and exclusion criteria are a set of eligibility criteria that determine if a participant may be enrolled in a study. The inclusion criteria determine the characteristics a person must meet to be able to participate, while the exclusion criteria determine the characteristics that prevent a person from participating.

The inclusion and exclusion criteria can include:

  • Age
  • Gender
  • Pre-existing conditions- type and stage of disease
  • Current medications
  • Previous treatments

There must be a clinical rationale for the set criteria and every effort should be made to include a diverse population by having broader inclusion criteria and narrower exclusion criteria.

The purpose of the inclusion and exclusion criteria is to ensure the validity of the study while maintaining the safety of the participants.

Source: U.S. Food and Drug Administration. (2018, April). Evaluating inclusion and exclusion criteria in clinical trials- Workshop Report.