Before joining a clinical trial, a participant must qualify for the study. All clinical trials have guidelines about who can participate, called inclusion/exclusion criteria. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria.
These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Inclusion and exclusion criteria are not used to reject people personally. Rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information that they need.
If you agree to participate in the study, you will be required to sign an Informed Consent Form (ICF). The ICF contains information about the study, which your doctor will explain so you can decide if you want to participate.
If you agree to participate in the study, your doctor will have up to 4 weeks to complete the necessary tests to see if you are eligible.