April 17
Clinical Trials
	A clinical trial is a research study that is designed to answer specific questions about new therapies and procedures to determine if they are safe and effective. Many people sign up for clinical trials in order to obtain new treatments that may not be available otherwise for their disease. Some people simply want to contribute to medical research. But before entering into a clinical trial, you should know what you’re getting into. The research study follows a strict protocol, which is a set of rules that determines who is eligible for the study, how the procedure is done or medicine is given, and the length of the study. A Phase I trial is the first trial of a drug to determine a safe dose, how it should be administered, and identify side effects; in general, it’s studied on a small group of people. Phase II trials provide the drug to a larger group of people to further determine the safety and effectiveness of the drug. Phase III studies attempt to confirm the effectiveness of the drug, monitor side effects, and compare it to other treatments. Phase IV studies are performed after the drug has been approved and marketed to study the effectiveness and any side effects associated with long term use. In general, you should know: the benefits you’ll receive from participating in a clinical trial, how you will be protected from harm, how your privacy will be protected, and how you will learn about the results of the study. Other questions to consider are: what are the potential side effects or bad outcomes that could occur; where and by whom is the study conducted; how often will you have to return for follow up; and what are the costs to you? You’ll want to find out ahead of time if your insurance covers any experimental treatment and under what circumstances. ClinicalTrials.gov was developed by the National Institutes on Health as “one stop shopping” for clinical trials. It contains thousands of studies, good general information, and links to other resources. If you’re considering a study, let your doctor know so that he or she can make sure your current treatment won’t conflict with any potential treatments you may receive.
	Resources: Clinical Trials.gov  National Institutes of Health www.clinicaltrials.gov Taking Part in Research Studies: What Questions Should You Ask? Centers for Disease Control and Prevention www.cdc.gov/nchstp/hiv_aids/pubs/brochure/unc3bro.htm Clinical Trials (Research) National Women’s Health Information Center www.4women.gov/faq/clinical.htm Understanding Clinical Trials from the Patient’s Perspective U.S. Food and Drug Administration www.fda.gov/oashi/cancer/pdart.html Some Things Only a Woman Can Do! Society for Women’s Health Research www.cando.org