What is a clinical trial?

A clinical trial is a research study to answer specific questions about vaccines, new drugs or medical devises, or new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study. Anyone participating in a clinical trial in the United States is required to read, understand, and sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent also tells patients that they have a right to leave the study at any time.

If you have been asked to participate in a clinical trial, or are considering it, here is a list of questions to ask:

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• Who is sponsoring the trial?
• Do I have to pay for any part of the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?

Any investigator running a clinical trial is obligated to explain and answer all questions from a potential participant. You have a right to have all your questions answered to your satisfaction before participating in a clinical trial.