BE WELL INFORMED

If you are considering enrolling in a clinical trial, there are many things to think about. Understanding the basics of clinical trials and the process can help you make a more informed decision. The following information will help get you started, and there is much more in the Resources section.

What is a clinical trial?

Once a proposed treatment or medicine is found to be helpful and safe in test tubes and in animals, it must also prove safe and effective in humans. This evaluation period is known as a clinical trial. Clinical trials, also called research studies or protocols, help doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses.

The decision to participate in a clinical trial is a very personal one. However, there are guidelines to protect study participants. Testing in humans is permitted only in volunteers who have been briefed about both the potential benefits and hazards of trial participation. This is called informed consent. It is the responsibility of the trial’s medical team to explain the risks to potential study participants.

Before enrolling in a clinical trial, it is important to fully understand what participation will entail. The informed consent statement has detailed information about the study, including the length of the study, the number of visits required, medical procedures and medications included. It also provides expected outcomes, potential benefits and possible risks. After receiving this information, the patient should discuss trial participation with his or her physician and family. Volunteers may leave a study at any time.

In order to help patients make this very important decision, the NIH developed the following set of questions. The trial coordinator and your personal physician can help you answer these questions. You should feel comfortable with your answers before enrolling in any study:

• What is the purpose of the study?
• What is required of me?
• What is my role in the study? Am I a healthy volunteer or a patient volunteer?
• Will the study directly benefit me?
• Will the study benefit others?
• Are there risks? If so, what are they and what are the chances that they will occur?
• What discomforts are involved?
• What is the total time involved?
• Are there other inconveniences?
• Have I discussed participation in the study with those who are important to me, such as family and friends?
• Do I wish to participate in this study?

For more information

The following sites contain additional information that may be of interest if you are considering participating in a clinical trial:

Understanding Clinical Trials - An Introduction to Clinical Trials provided by the National Institutes of Health

Your rights and informed consent - WebMD's information on patients' rights on deciding to participate in a clinical trial.

Click here to find out if this trial is right for you or a member of your family.

Click here to find out which of the clinical centers in the US and Canada is closest to you.

Toll-free study info:

1-877-STOP-T1D
(1-877-786-7813)