Exclusion criteria
Encyclopedia
Exclusion criteria are the standards used to determine whether a person may or may not be allowed to participate in a clinical trial
. The most important criteria used to determine appropriateness for clinical trial participation include age
, sex
, the type and stage of a disease
, treatment history, and other medical conditions.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
. The most important criteria used to determine appropriateness for clinical trial participation include age
Ageing
Ageing or aging is the accumulation of changes in a person over time. Ageing in humans refers to a multidimensional process of physical, psychological, and social change. Some dimensions of ageing grow and expand over time, while others decline...
, sex
Sex
In biology, sex is a process of combining and mixing genetic traits, often resulting in the specialization of organisms into a male or female variety . Sexual reproduction involves combining specialized cells to form offspring that inherit traits from both parents...
, the type and stage of a disease
Disease
A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal dysfunctions, such as autoimmune...
, treatment history, and other medical conditions.
See also
- inclusion criteriaInclusion criteriaInclusion criteria are a set of conditions that must be met in order to participate in a clinical trial. In other words - the standards used to determine whether a person may be allowed to participate in a clinical trial...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- U.S. Food and Drug Administration (FDA)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...