About Clinical Trials A clinical trial is a research study that is designed to evaluate a new drug or combination of drugs. Clinical trials are studies conducted in human volunteers and are the basis of our knowledge of new treatments and whether or not they are safe and effective enough for the general public. If the information gathered in clinical trials of a certain drug suggests that the drug may provide a benefit and is safe, the results are submitted to the U.S. Food and Drug Administration (FDA) for review. The FDA decides whether or not the drug will be approved for public use. Sources of Clinical Trials Information There are many websites that provide detailed information about clinical trial participation. In particular, the U.S. National Institutes of Health (NIH) website, www.clinicaltrials.gov, provides a wealth of valuable information. The NIH website also provides information and links to additional sources of clinical trial information. To go directly to the NIH website "Links to General Information on Clinical Trials" Click Here. What Are The Risks and Benefits of Clinical Trial Participation? Participation in a clinical trial may help to answer important scientific questions that ultimately may benefit the care of patients in the future. Becoming involved in a clinical trial may lead to the opportunity to try a new drug or therapy which may provide clinical benefit. However, there is no guarantee that an investigational drug will work. In addition to how well a therapy works, clinical trials also investigate side effects that may be caused by a new drug. Because the treatment is investigational, side effects are often not predictable or known. Some Risks and Benefits of Clinical Trial Participation Below is a list of basic benefits and risks, but it is by no means a complete list. To learn more about the benefits and risks of clinical trials, talk to your doctor. Benefit: A new treatment may provide benefit over available treatments. Risk: The new treatment may not work as well as approved treatments. Benefit: The side effects of the new treatment may be milder than other available treatments. Risk: The side effects of the new treatment may be more severe than other available treatments. Benefit: Participants are followed closely by the research team. Risk: Participants may be required to visit their doctor more often and more testing may be needed than non-research treatments. For additional information regarding the benefits and risks of participation in a clinical trial please go to the following NIH clinical trials website link: http://www.clinicaltrials.gov/ct/info/whatis#br Deciding Whether to Participate in a Clinical Trial Deciding whether or not to participate in a clinical trial can be challenging. Participation in a clinical trial may have its benefits, but there are also risks involved. It is important to learn as much as possible about clinical trials in general, as well as, the details and requirements for the trial that you may be interested in. Finally, you should always discuss any information about clinical trials with your doctor. For more information on important considerations associated with the participation in a clinical trial please go to the following NIH clinical trials website link: http://www.clinicaltrials.gov/ct/info/whatis#consider
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