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Clinical trials: A chance to try evolving therapies
Clinical trials offer you a chance to try new treatments. Should you participate in a clinical trial? Learn more about how clinical trials work.
By Mayo Clinic staffYou may have heard about clinical trials — studies of possible new treatments or medications — but wonder what exactly they are and if one might be right for you. Choosing to participate in a clinical trial can be a complex decision. You first need to understand what clinical trials are and how they're used to test new treatments.
What are clinical trials?
Clinical trials are research studies designed to find answers to specific health questions. Clinical trials often look at new drugs or new combinations of drugs (new or old), new surgical procedures or devices, or new ways to use existing treatments. Clinical trials can also look at other aspects of care, such as:
- Preventing diseases
- Screening for and diagnosing health problems
- Quality of life for people with chronic illnesses
Before a new approach can be tested in a clinical trial, it must already have shown some benefit in laboratory testing, animal experiments or in testing with a small group of volunteers.
The goal of clinical trials is to determine if a new treatment both works and is safe. In fact, new medications cannot be sold in the United States until they have been through clinical trials. Therapies that prove effective during clinical trials may go on to become approved and widely available treatment options.
Who can participate in clinical studies?
Researchers are typically looking for people with the specific disease they're studying. Some trials are limited to people who haven't started treatment, while others focus on people for whom standard treatment has failed. Healthy people are needed for some trials. Researchers also consider age, sex and race, among other factors, when selecting people for clinical trials.
Why do people volunteer for clinical trials?
If treatment for your disease isn't available or the standard treatment hasn't worked for you, you might consider a clinical trial. Clinical trials can provide access to new or experimental treatments that otherwise aren't available. However, there is no guarantee that the treatment will be effective for you. In addition, clinical trials may use a placebo — a pill or liquid that looks like the new treatment but has no active ingredients — as a comparison for the drug being tested. You can't control whether you receive the placebo or the new treatment. Despite these caveats, clinical trials offer hope for many people and an opportunity to help researchers find better treatments for people in the future.
How do you enroll in a clinical trial?
Your doctor might recommend a clinical trial to you, or you might find out about a trial on your own. Often patient advocacy groups let their members know about clinical trials that are recruiting. If you live in a large city, your local newspaper may carry advertisements for clinical trials at nearby research centers. The National Institutes of Health posts listings of thousands of clinical trials online.
Once you find out about a trial you're interested in:
- Talk to your doctor. Your doctor might be familiar with the drug or therapy involved in the trial. Your doctor can discuss with you the benefits and risks of the clinical trial and whether you might be eligible to participate.
- Contact the clinical trial coordinator. This person is often listed with the clinical trial announcement. You or your doctor can take this step. You or your doctor will talk with the study coordinator about your health and whether you meet the criteria for the study.
- Schedule a pretrial screening. You'll undergo various tests to help the researchers decide whether you qualify for the clinical trial. You'll also get a chance to talk to the investigators about what the trial involves, as well as its risks and benefits.
How much will you know about the treatment being investigated?
It's crucial that you have enough information about the study and the treatment being investigated to make a well-informed decision. To ensure that you do, the study facilitators provide what's called an informed consent document. You must read and sign an informed consent form before being allowed into the trial. This informed consent document contains information you need to know about the study before deciding whether to participate. Some of the information on an informed consent document includes:
- What will happen during the clinical trial, including tests you may be given
- Known risks and benefits of the experimental treatment
- How long you'll be expected to participate in the clinical trial
- Other treatments that might be helpful to you instead of the treatment being tested
- Whom to contact with questions
The form must explain this information in words you can understand. Researchers aren't allowed to pressure you into signing up for a trial. Signing the informed consent form means you agree to participate in the trial. It isn't a contract. If you later decide to leave the study, you may do so without any penalty.
If your child will be enrolled in a clinical trial, you will go through the informed consent process together. As the parent or guardian, you will have to give permission for your child to participate. Depending on your child's age, researchers may also ask your child directly if he or she agrees to be in the study.
Next page(1 of 2)
- Clinical trials: Questions and answers. National Institutes of Health. http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials. Accessed May 15, 2009.
- Basic questions and answers about clinical trials. U.S. Food and Drug Administration. http://www.fda.gov/oashi/clinicaltrials/clintrialdoc.html. Accessed May 15, 2009.
- Inside clinical trials: Testing medical products in people. U.S. Food and Drug Administration. http://www.fda.gov/fdac/special/testtubetopatient/trials.html. Accessed May 15, 2009.
- How to enroll in a clinical trial. National Cancer Institute. http://bethesdatrials.cancer.gov/general-public/index.asp. Accessed May 15, 2009.
- How is a clinical trial planned and carried out? National Cancer Institute. http://www.cancer.gov/clinicaltrials/learning/how-trials-are-done. Accessed May 15, 2009.
- A guide to understanding informed consent. National Cancer Institute. http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide. Accessed May 20, 2009.
- The FDA's drug review process: Ensuring drugs are safe and effective. U.S. Food and Drug Administration. http://www.fda.gov/fdac/special/testtubetopatient/drugreview.html. Accessed May 26, 2009.
