Who can participate in a study?
Before joining a clinical study, you must first qualify for the study. All clinical studies have guidelines about who can participate to ensure it is for you. The use of inclusion/exclusion criteria is an important principle of clinical research that selects the proper participants. The factors that allow you to participate in a clinical study are called “inclusion criteria” and those that disallow you from participating are called “exclusion criteria.”
These criteria are based on such factors as age, the type and stage of disease, previous treatment history, and other medical conditions. Some research studies seek subjects with illnesses or conditions to be studied, while others need healthy subjects. It’s not personal! Inclusion and exclusion criteria are not used to reject potential participants. Instead, they are used to identify the right subjects and keep them safe.
The criteria help ensure that researchers will be able to answer the questions posed in the study.