What are eligibility criteria (inclusion/exclusion criteria)?
Participants in clinical trials must eligibility criteria (inclusion/exclusion criteria) that are outlined in the protocol. These criteria, which differ from trial to trial, include such characteristics as gender, age, health problems, and previous or current treatments. These criteria help to prevent those who may be harmed by the study drug or device (such as pregnant women) involved in the research. The criteria also help to produce scientifically reliable and valid results by ensuring that the same types of patients are enrolled across the country. This allows researchers to more accurately determine the benefits and risks of the study drug or device.
