In a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, the investigators must specify inclusion and exclusion criteria for participation in the study.
Inclusion and exclusion criteria define the characteristics that prospective subjects must have if they are to be included in a study. Although there is some unclarity concerning the distinction between the two, th
ICH E3 guidelineon reporting clinical studies suggests that
* Inclusion criteria concern properties of the target population, defining the population to which the study's results should be generalizable. Inclusion criteria may include factors such as type and stage of
disease
A disease is a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury. Diseases are often known to be medical conditions that a ...
, the subject’s previous treatment history,
age
Age or AGE may refer to:
Time and its effects
* Age, the amount of time someone or something has been alive or has existed
** East Asian age reckoning, an Asian system of marking age starting at 1
* Ageing or aging, the process of becoming older ...
,
sex
Sex is the trait that determines whether a sexually reproducing animal or plant produces male or female gametes. Male plants and animals produce smaller mobile gametes (spermatozoa, sperm, pollen), while females produce larger ones ( ova, of ...
,
race
Race, RACE or "The Race" may refer to:
* Race (biology), an informal taxonomic classification within a species, generally within a sub-species
* Race (human categorization), classification of humans into groups based on physical traits, and/or s ...
,
ethnicity
An ethnic group or an ethnicity is a grouping of people who identify with each other on the basis of shared attributes that distinguish them from other groups. Those attributes can include common sets of traditions, ancestry, language, history, ...
.
* Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing to sign informed consent), to overcome practical issues related to the study itself (e.g., not being able to read, when questionnaires are used for assessment of outcomes), or to eliminate factors that may limit the interpretability of study results (e.g., comorbidities). Exclusion criteria may lead to biases in the study's results.
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
A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population. A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ethnic diversity.
See also
*
Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for re ...
*
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA)
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
References
{{reflist
External links
ICH Website: Guidelines for Clinical Trial ManagementFDA WebsiteCareers in Clinical ResearchClinical Research ServicesClinical Trial Management Companies Listings
Clinical research
Pharmaceutical industry