Clinical trials are done to 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.
Many 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 disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves into 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.
What Are the 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 don’t always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. 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, FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:
- that the study involves research of an unproven drug or device the purpose of the research how long the study will take what will happen in the study and which parts of the study are experimental possible risks or discomforts possible benefits other procedures or treatments that you might want to consider instead of the treatment being studied that FDA may look at study records, but the records will be kept secret whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for the treatment the person to contact with questions about the study, your rights, or if you get hurt you can quit at any time.
Informed consents must be written so you can understand it. If you don’t, be sure to ask the doctor or other medical person to explain it. Make sure you understand all of it before you agree to be in the study.
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.