According to the U.S. Food and Drug Administration (FDA), a clinical study is a research study conducted in human volunteers to answer specific health questions. Individuals participate in clinical research for many reasons. These include the opportunity to take an active role in one’s own healthcare, to access new research treatments before they are widely available, and to help those diagnosed with the same disease in the future by contributing to medical research.¹

Clinical studies are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.²

Note that inclusion and exclusion criteria are used to help identify potential participants.

• ENLIGHT Eligibility Criteria

Additional Clinical Trial Resources:

• www.ClinicalTrials.gov
• National Institutes of Health
• U.S. Food and Drug Administration
• The Center for Information & Study on Clinical Research Participation