Overview of Clinical Trials

What is a clinical trial?

A clinical trial is a research study involving people who volunteer to test new drugs and treatments to determine if they are safe and effective. The tests are carefully designed and carried out. People who choose to participate are regularly checked to assess how the treatment is working.

Participation in a clinical trial does not substitute for regular medical care. You are encouraged to discuss participation in clinical trials with your physician.

Why participate in a clinical trial?

Many common treatments, such as brand name pain killers, would not exist without clinical trials. By participating in a clinical trial you may:

• Help others by contributing to medical research
• Gain access to new treatments
• Receive treatments at low or no cost
• Be compensated for your time and any inconvenience related to the study

Who can participate in a clinical trial?

This depends on the question being asked. Some clinical trials look for people with certain diseases, and others need healthy people.

Participation in a clinical trial is based on criteria such as age, gender, certain medical conditions and treatment history, or your daily behaviors (for example, if you smoke). These are used to identify the highest safety standards while addressing the specific research questions.

What should you think about before participating in a clinical trial?

Learn as much as possible about the study and feel free to ask questions such as:

• What is the purpose of the study?
• Who is going to be in the study? How many will participate?
• Why do researchers believe the experimental treatment being tested may be effective?
• What kinds of tests and experimental treatments are involved?
• What are the possible risks, side effects, and benefits of the study treatment?
• How might this study affect my daily life?
• How long will the study last? How long will I be involved?
• Will I have to stay in the hospital?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What kinds of follow-up care will I have to do as a part of this study?
• Will I receive a copy of my own test results?
• Will my family physician know about my participation in the study?
• Will results of the study be provided to me?

Learn More

For information on how clinical research is conducted, how to participate, and current research results, visit the National Institutes of Health website Clinical Research Trials and You.