CLINICAL TRIALS FAQ
Q: What is a Clinical Trial?
A: Before a drug may be prescribed by a doctor, it must first be approved by the Food and Drug Administration (FDA). To obtain this approval, clinical studies must be carried out to establish the efficacy and safety of the drug. Here, it is essential that the studies are carried out in accordance with precisely defined rules and conditions.
When the preclinical development phase has been completed successfully (i.e. in particular, on conclusion of the tests and experiments with animals), a new substance is tested on human subjects. This testing is divided into four phases:
Phase I Studies: The drug that is to be tested is administered to healthy people, known as subjects. These are people who volunteer to test – within the framework of a clinical trial (study) – new medical agents or agents that have not yet been approved in the United States.
Phase II Studies: In Phase II studies, the drug is, for the first time, tested on patients suffering from the illness that is to be treated with this drug. Phase II studies aim to gather information on the efficacy, safety and the dose, or effect ratio, of the medication.
Phase III Studies: Here, the drug that is being tested is administered to a larger number of patients. The aim in this phase is to examine the efficacy of the drug in day-to-day use, the possible side effects and safety as well as any possible interactions between medications.
Phase IV Studies: These studies are only carried out after a drug has been approved. A Phase IV study aims to gather further information relating to the benefits and risks associated with the drug as well as information on its use, for example, in other areas of application.
Q: Why should I participate in a Clinical Trial?
A: There are many reasons people decide to participate in a clinical trial:
• The opportunity to receive new research treatments before they are available to the public
• To get access to promising new drugs or devices
• The ability to be monitored for a serious health condition very closely
• To receiving study-related supplies, medications, laboratory tests, physical exams and perhaps more personalized attention
• Many people feel it is a satisfying way to help others.
Q: What kind of research is conducted at the Diabetes Research Center?
A: The Diabetes and Metabolism Research Center and the OSU Division of Endocrinology conduct research in islet cell transplantation and pancreas allograft transplantation, and type 1 and type 2 diabetes.
Q: How do I enroll in a clinical trial?
A: If you have type 1 or type 2 diabetes and are interested in enrolling in a clinical trial, please contact:
Kelly Rogers, M.S.
Clinical Research Coordinator
Division of Endocrinology, Diabetes and Metabolism
3054 Taylor Avenue