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What is a Clinical Trial? A clinical trial is a research study carefully designed to answer specific questions about new medications or new ways of using previously approved medications. Clinical trials measure the medication's ability to treat a medical condition and how safe it is to use. The FDA (Federal Drug Administration) has strict rules by which all clinical trials must be conducted. The FDA then looks at the results of the studies to decide whether to approve them for use by the general public. What are the benefits of participating in a clinical trial? Research is the beginning of all understanding of diseases and medication to treat them. Only through research do we advance toward treatments and possible cures. Being a supporter of research is hoping for the future.
Who can participate? All clinical trials have guidelines about who can participate in the program. Guidelines are based on factors such as age, medical history and current medical status. Before you join a clinical study, you must qualify for the study. The study physician reviews each volunteer's medical history to determine who can participate.
Please note that guidelines for the study, also known as inclusion/exclusion criteria, are not used to reject people personally, but to identify appropriate volunteers and keep them safe. Participation in a clinical trial is completely voluntary and as a volunteer you have the right to stop participating at any time.
Who looks out for my interests? In addition to the physicians and staff at Alliance Research Group, the research sponsor and the FDA, U.S. law requires that an ethics committee (called an Institutional Review Board, IRB) look out for your interests. The IRB consists of a group of independent health care professionals and community members chartered to protect the safety and rights of research volunteers. IRBs must approve clinical studies before they begin. They also monitor studies as they proceed.
How do I learn more? In order to participate in a clinical study, you must be fully informed about the study and give your consent to participate. This information includes an explanation about the study procedures, potential risks and benefits as well as your responsibilities as a study participant. You are encouraged to ask questions and share this information with your family, friends and doctor.
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