|Every year, many thousands of people take part in clinical trials. Some of these studies need healthy volunteers and others need participants with a particular disease or condition. All participants are important because without them, the development of new medicines couldn’t continue.
All clinical trials have rules about who can participate, called Inclusion and Exclusion Criteria. Factors that allow someone to participate in a clinical trial are Inclusion Criteria. Those that disqualify someone from participating are called Exclusion Criteria. These criteria are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Inclusion and Exclusion Criteria are developed with much thought and consideration. They are necessary to prove whether medicines work or not in a specific group of people and to reduce risk of problems by making sure the right participants enter the trial. These criteria are applied to all potential participants in the same way, before they start participating in the study.
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