Researchers check the safety of the medicine or treatment, the best dose or schedule to use, and what types of side effects occur. During this phase, all the people involved in the study patients, doctors, and researchers know what medicine is being used. These are called nonrandomized, nonblinded studies. The medicine or treatment is tested on a larger group of people with certain conditions or diseases.
This phase helps researchers find out how well a medicine or treatment will work to treat a particular problem. Phase II trials are also usually nonrandomized, nonblinded studies. The medicine or treatment is tested on even larger groups. The medicine is studied to find out how well it works compared with standard treatment or placebo. Researchers also study whether the medicine improves specific areas in your life, such as how well you are able to keep your usual routine.
Most medicines that reach this phase will be considered for FDA approval. During phase III trials, participants receive the study medicine, a placebo, or the standard treatment. Neither the participants, the doctors, nor the researchers know which person is getting which medicine. These are called randomized and double-blinded studies. Medicines are also studied after they are approved. These studies can find new uses for the medicine, different ways to give it, or more safety information.
For example, a medicine may be studied to see how well it works for a certain population, such as adults over the age of 65 or a certain racial group.
After a clinical trial is completed and the results are studied, the FDA decides whether to approve continued development of the medicine. If the medicine that you received remains in development, you may be able to get more doses as an extension of the study. If the results of the clinical trial show that the new medicine or combination of medicines works much better than standard treatment, the new medicine may become available to the general public.
Your treatment team may continue to check on you after your trial is over. You should be fully informed about the possible risks of the trial before you agree to participate.
Every clinical trial in the United States must be approved and monitored by an institutional review board IRB. This makes sure that the risks are as low as possible and are worth any potential benefits. The ethical and legal rules for medical practice also apply to clinical trials. Most clinical research is regulated by the U.
Clinical trials follow a carefully controlled study plan protocol that explains what everyone will do in the study. During the clinical trial, researchers report the results of the trial at scientific meetings, to medical journals, and to government agencies. Your name will remain secret and will not be mentioned in these reports. Sometimes the group sponsoring your trial will be responsible for the cost of the medicine as well as the costs of medical tests that are required while you are in the trial.
Clinical trials usually require you to have more medical tests than you would have if you were not in the trial. But in other trials, the cost of the medicine and only some of the medical tests will be covered. Some studies will reimburse you for the cost of traveling to and from your medical visits.
The U. You can contact this service online at www. Or you can get information over the phone by calling or For cancer-related clinical trials, go to www. Trained staff who speak English and Spanish can answer questions and help you search for clinical trials for your type of cancer.
There may or may not be a clinical trial available in your area that relates to your particular disease or stage of disease. Author: Healthwise Staff. Medical Review: E. This information does not replace the advice of a doctor. Healthwise, Incorporated disclaims any warranty or liability for your use of this information.
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For a list of covered benefits, please refer to your Evidence of Coverage or Summary Plan Description. For recommended treatments, please consult with your health care provider. We are unable to switch you to this area of care. Clinical Trials. Skip Navigation. Overview Clinical trials are research studies in which people help doctors find ways to improve health care. Why clinical trials are important Clinical trials are important because they allow researchers to find out if a new treatment works as well as or better than accepted treatments.
How clinical trials work Your doctor will help you find out if you are eligible to take part in a clinical trial. After that: You will be given a structured program to follow. You will have a schedule of tests, doctor appointments, and treatments. You may be asked to keep a diary of your experience during this time. Phases of a clinical trial A medicine or treatment must go through three phases before it is approved for use by the FDA.
William Towner, MD, has seen firsthand how clinical trials can contribute to the development of more effective and safer medical treatments. We are now able to treat HIV with one pill taken once a day, and patients usually do very well. Since those early days, Dr. Towner has served as principal investigator for more than clinical trials in his role as physician director for clinical trials at Kaiser Permanente in Southern California. These neurobiological disorders involve a complex interplay between genetics ….
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