Inclusion and exclusion criteria

For Wikipedia's inclusion criteria, see: What Wikipedia is not.

Definition

In a clinical trial, the investigators must specify Inclusion and exclusion criteria for participation in the study.

Inclusion criteria are characteristics that the prospective subjects must have if they are to be included in the study, while exclusion criteria are those characteristics that disqualify prospective subjects from inclusion in the study. Inclusion and exclusion criteria may include factors such as age, sex, race, ethnicity, type and stage of disease, the subject’s previous treatment history, and the presence or absence (as in the case of the “healthy” or “control” subject) of other medical, psychosocial, or emotional conditions.

Exclusion criteria

Poorly Justified Reasons for Exclusion:

Any criteria unless the condition or intervention is specific to the criterion, or the criterion has a direct bearing on condition/intervention/results.

Strongly Justified Reasons for Exclusion:

Unable to provide informed consent

Placebo or intervention would be harmful

Lack of equipoise (intervention harmful)

Effect of intervention difficult to interpret

Potentially Justified Reasons for Exclusion

Individual may not adhere

Individual may not complete follow up

Individuals do not have reliable information

Example of Inclusion and exclusion criteria

Coronary Heart Disease

Include criteria:

Minimum outcomes: coronary deaths & non-fatal myocardial infarction

Appropriate measures of Framingham variables (Age, sex, LDL, HDL, total cholesterol, diabetes, smoking status, hypertension)

Cohort, nested case-control, cardiovascular trial follow-up study (or systematic review or meta-analysis of these study types) that measures a novel risk factor and estimates its predictive value after adjusting for Framingham variables

Exclude criteria:

No data

Population or sub-population with known coronary disease or coronary disease equivalent (e.g., diabetes)

Does not include minimum outcomes

Does not measure Framingham variables appropriately

Wrong study design/article format

See also

• Drug development
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency

External links

• ICH Website: Guidelines for Clinical Trial Management
• FDA Website
• Careers in Clinical Research
• Clinical Research Services
• Clinical Trial Management Companies Listings