Who Can Join
People of all ages, sex, race, or ethnic groups can be in clinical trials. The kinds of people needed for a trial depend on the trial itself and the questions it is trying to answer. Some people in the trial are healthy, while others will have the specific illness in question.
There are two types of Clinical Trial Volunteers:
Some clinical trials include healthy volunteers. A healthy volunteer is a person with no known significant health problem. Healthy volunteers usually do not get direct health benefits from joining a clinical trial.
A patient volunteer has a known health problem. This person may join a clinical trial to help researchers understand or treat that condition. Although this person may get direct health benefits from joining the study, the main reason is to help doctors understand whether a treatment works or not.
- Usually in Phase I and II studies, the participant gets the new treatment.
- In Phase III studies, some participants get the new treatment and others get a current treatment. There is no guarantee that the participant gets one treatment or the other because a computer randomly assigns the participants. This is done to create a fair comparison between the new and the current treatments.
Inclusion and Exclusion Criteria
Each study has its own specific rules. Before joining a study, a person must meet the eligibility requirements and not be ruled out based on exclusion criteria. Usually, these rules are based on things like age, sex, the type of disease, how far along is the disease, previous treatment, and other medical issues.
These rules are not to reject anyone personally. They are used to find people who may benefit from the experimental treatment, keep out people who may be harmed, and help researchers find the information they need. Participating in a clinical trial contributes to medical knowledge and may make a difference in your health status or the care of future patients. Clinical trials also involve a degree of risk, which may be greater than the risks associated with existing treatments. The researcher conducting the study will explain the risks of a trial and you will be asked to sign a consent form if you understand and accept those risks.
Choosing to participate in a clinical trial is an important personal decision and the decision to enter a clinical trial, if you meet the criteria for participating, is always up to you.