A clinical trial is a test or study of a drug or medical device in people. These tests are done to see if a product, treatment, therapy or device is safe and effective for people to use. The Food and Drug Administration sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.
Should I Volunteer?
By taking part in a clinical trial, you can try a new treatment that may or may not be better than those that already exist.
What Happens in a Clinical Trial?
Clinical trials test whether new products are safe and work against disease. Study products are tested to see how they compare to standard treatments or to no treatment if there is not presently one.
Some studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all.
Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can safely give.
Phase 2 studies include more people than Phase 1 studies, and the people have the disease that the product is going to treat. Researchers try to see how well the product works against the disease. If the product works, the study moves to Phase 3. Here large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
Are there Risks?
Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors do not always know what the side effects will be. The risks depend on the treatment being studied and all known risks should be fully explained to you by the researchers.
How am I Protected?
To help you decide if you want to be in a study, the FDA requires that you be given complete information about the study before you agree to take part. Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is NOT a contract and you can leave the study at any time, for any reason.
Institutional Review Boards (IRBs)
Scientists, doctors and other people from the local community serve on IRBs to review and monitor the research institution's medical research involving people. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits.
FDA inspects records and various scientists, clinics, and other research sites involved in a study. The agency does this to make sure volunteers are being protected and studies are being done correctly.
What Questions Should I Ask?
- What is the study trying to find out?
- What kinds of test and exams will I have to take while I am in the study? How much time do these take? What is involved in each test?
- How often does the study require me to go to the doctor or clinic?
- Will I be hospitalized? If so, how often and for how long?
- What are the costs to me? Will my health insurance pay for it?
- What follow-up will there be?
- What will happen at the end of the study?
- What are my other treatment choices? How do they compare with the treatment being studied?
- What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
- How long will the study last?