Clinical trials are a scientific test of the effectiveness and safety of a therapeutic intervention (as a drug, surgery, procedure, device, or vaccine) involving consenting patients. Clinical trials can also test new uses of drugs or treatments that are already approved by the Food and Drug Administration for a specific use. Clinical trials are carried out under strict guidelines with great attention to measures of safety.
People participate in clinical research for a variety of reasons. People who volunteer for clinical trials may gain access to promising drugs before these compounds are approved by the Food and Drug Administration for the marketplace. Others choose to participate as a way to advance science.
At UTMB and at the Texas Transplant Center, the rights and safety of patients are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the Federal Government must obtain approval to conduct the study from an Institutional Review Board (IRB). The IRB, which is usually composed of physicians from different specialties as well as people with no formal science training, 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 signs an "informed consent" form. This form details the nature of the study, the 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.
Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.
For information on studies currently under way at the Texas Transplant Center, please contact us.