Allergic Diseases, S.C. Steven H. Cohen, M.D.
Home Doctor First Visit Office Policies Medical Info Clinical Trials Why Participate Current Trials Contact Us FAQs Links	Clinical Trials What is a Clinical Research Study? A clinical research study is a process designed to evaluate the safety and/or effect of an investigational medication, or device or to look for new illness to use a medication already approved by the FDA (Food and Drug Administration). These studies are required by the FDA and closely monitored by that agency to insure that new treatments are safe and effective before they can become licensed. Clinical trials are sponsored by private organizations, such as pharmaceutical companies, or government agencies to find better ways to treat diseases. A study is designed to look for patients with certain disease states or characteristics, to treat them and to evaluate their response to that treatment. An ethics group called an Institutional Review Board (IRB) reviews the proposed study to help protect the participants' rights and safety. The IRB approves a document called an informed consent form which, among other things, explains the study being done, discusses benefits and potential risks, lists what the participant needs to do and will have done, and any compensation the participant may expect to receive. Participants always have the opportunity to ask, and have answered, any questions they have related to the study or their participation before signing the informed consent. If a person is interested and meets the inclusion and exclusion criteria, they can try to qualify for the study. A detailed history is taken followed by a physical examination. Testing may be done, according to the disease studied and the requirements of the study, to see if the participant meets all the criteria and can be randomized (entered into one of the "arms" or the study). This is usually done in a blinded fashion by a third party who decides which form of treatment the participant receives. In this way neither the patient nor the people conducting the study can be biased in reporting their results. The study may compare active medication to placebo (an inactive form that looks like the active form), different strengths of active medication, or two active medications. Studies always have alternative action or additional medications to use as a rescue if the participant has significant symptoms. If a volunteer has symptoms that are poorly controlled and wants to stop their participation, they are free to do so at any time. Safety of the volunteer is always the first concern of any clinical study.      11121 W. Oklahoma Avenue    West Allis, WI 53227    Tel: 414.545.1111