What is a Clinical Trial?
A clinical trial is the study of a medical treatment in human participants. Medical treatments can be drugs; surgical devices, such as an artificial hip; medical devices, such as an insulin pump; or surgical techniques. The purpose of a clinical trial is to answer questions about safety and possible side effects. Clinical trials also determine treatment efficacy to aid the Food and Drug Administration in approving or rejecting that treatment for use.
Volunteers participate in clinical trials for a number of reasons. Some participate to gain access to promising drugs long before they are approved for the marketplace; while others opt to participate in clinical trials to benefit from the excellent care the study team provides during the course of the trial. Such special care may even be free. Still others may participate in a clinical trial because they enjoy the opportunity to contribute to medical research, thereby helping other patients while playing an active role in their own healthcare.
Your rights and safety are protected in two important ways. First, any physician awarded a clinical trial by a pharmaceutical company must obtain approval to conduct the study from an Institutional Review Board. The review board, which typically comprises both physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected and that the study does not present an undue or unnecessary risk to the patient. Second, 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, the risks involved, and what the patient can expect during the course of the study. The consent form also informs patients that they have the right to opt out of the study at any time.
Choosing to participate in a clinical trial is a serious personal decision. Discussing your possible participation with physicians and/or family members and trusted friends can help you make this important decision.
Our staff at the Medical Center for Clinical Research looks forward to working with you and will be happy to answer whatever questions you may have.