Who can participate in a clinical trial?
All clinical trials have guidelines in the study plan outlining individuals who can participate. The utilization of inclusion and exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow a person to participate in a trial are called inclusion criteria and those that disallow a person to participate are called exclusion criteria. These are based on factors determined by the study team including age, sex, disease stage and previous treatment history. Before entering a trial, a participant must qualify for the study. Some research studies seek participants with specific illnesses and conditions while others may require healthy participants. These requirements are not intended to reject individuals but to identify appropriate participants and keep them safe while answering specific questions planned during the study.