Contact ArQule About ArQule Product R & D Clinical Trials Patient Support - Advocacy Links Investors and Media Careers Home : Clinical Trials Clinical Trials An Overview A clinical trial is a research study of potential new medicines conducted in human volunteers to answer specific health questions. The U.S. Food and Drug Administration (FDA) requires a series of carefully conducted clinical trials of all drugs to determine whether they should be approved for wider use in the general population. The Investigational New Drug Application An investigational new drug application (“IND”) is required and must be approved by the FDA before the initiation of clinical trials of a new drug compound or biological product in the U.S. The IND generally includes detailed information about product manufacture and control, the results of pre-clinical studies evaluating the safety and efficacy of the drug, and detailed descriptions of planned clinical investigations in humans. The Phases of Clinical Trials Clinical trials may be conducted at hospitals and research centers in the U.S. and abroad. They are normally completed in sequential phases (Phases I-IV), although the phases may overlap. Each phase has a different purpose and provides data to help scientists learn more about a particular new or experimental drug. Phase I trials are concerned primarily with the safety and pharmacokinetics of the investigational drug. Phase II trials are designed primarily to demonstrate effectiveness and safety in treating a particular disease or condition. Phase III trials are typically large clinical trials intended to gather detailed information on the safety and effectiveness of a drug. These trials are used to determine if the drug will effectively treat a disease and to better define its side effects, as well as to generate information for proper labeling of the drug. When data is required from long-term use of a drug following its approval and initial marketing, the FDA can require Phase IV, or post-marketing, studies to be conducted. Individuals should learn as much as possible about the clinical trials that interest them. For further information on clinical trials, please visit the web site of the U.S. Food and Drug Administration, http://www.fda.gov, or a site sponsored by the U.S. National Institutes of Health, http://www.clinicaltrials.gov. Patients and Physicians How Do I Enroll in ArQule's Clinical Trials? Only you and your doctor should decide whether your enrollment in a clinical trial is right for you. Patients, physicians and other healthcare professionals seeking more information about ArQule’s clinical trials may e-mail clinicaltrials@arqule.com or call 1-800-373-7827 within the U.S. and Canada. The products described above are investigational and have not been approved by the Food and Drug Administration. © ArQule, 2011 | Terms and Conditions: Purchasing | Terms of Use