What is a Clinical Research Study?
Clinical research involves conducting clinical studies to prove the safety and effectiveness of investigational drugs that may offer better, future treatment of specific diseases. A clinical trial is a carefully designed study comparing an investigational drug or an already approved drug to a placebo (inactive product) or another approved drug. Clinical studies are usually sponsored by a pharmaceutical or biotechnology company and conducted under the supervision of physician investigators and other research professionals.
Anyone who participates in a research trial is protected in a number of ways. Any physician awarded a research grant must obtain approval to conduct the study from an Institutional Review Board. The review board, usually composed of physicians and lay people, is charged with making sure that patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Also, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.
