Welcome to the ITN Clinical Trial Recruitment Pages

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 researchers and physicians conducting a clinical trial are bound by strict rules. These rules are designed, monitored and enforced by the NIH and FDA. Any breach of these rules could result in serious consequences for the researchers. Needless to say, researchers are careful to follow the approved protocol to the T.

When it comes to drug studies, there are four types:

Phase 1 studies test a potential new drug with a small number of volunteers for best dosage and potential side effects.

Phase 2 studies test a drug with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body uses the drug and how the drug helps the condition.

Phase 3 and 4 studies compare the new drug with a commonly used drug.

Be informed

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?