Sensible Healthcare Clinical Research

Prior to participating in a clinical trial, an individual must qualify to be in a study.

Researchers define these guidelines as “inclusion and exclusion criteria.”

Participation criteria differ from study to study. Criteria may include age, gender, medical history and current health status. Eligibility criteria for treatment studies often require that patients have a particular medical condition.

Enrolling participants with similar characteristics ensure that the results will be due to what is under study and not other factors. Eligibility criteria help researchers achieve accurate and concise results. Using criteria also ensures that people who could be made worse by participating in the study are not exposed to the risk.

Examples of these criteria include:

• Limiting participants to a certain age range

• Requiring participants to be in a certain stage of the disease

• Not allowing health conditions other than the one being studied

• Not permitting use of other medications

• Requiring participation of a caregiver or "study partner"