Tennessee Urology Associates, PLLC participates in drug and device clinical trials for urology related diseases and conditions. The following information will provide you with a better understanding of participation in these studies.
What Are Clinical Trials?
Drugs and medical devices must undergo extensive testing before they can be approved by the Food and Drug Administration (FDA). Before testing which involves people, laboratory research is conducted with animals and human tissue. If this stage of testing is successful, the manufacturer may apply to the FDA to begin clinical trials. The results of the clinical trials will provide the manufacturer and the FDA valuable information.
Are Clinical Trials Safe?
There are several safeguards for volunteer protection built into the clinical trial process. Clinical trials follow strict FDA-approved plans called protocols. The protocol provides the physician with information on how the product must be used, what safety tests will be performed and how often the volunteer must come to the clinic during the trial. The protocol is also reviewed by an Institutional Review Board (IRB). The IRB, which is composed of physicians, scientists and lay people, helps determine that the study poses no unnecessary risks to the volunteer.
Should I Participate?
People participate in clinical trials for many reasons. Volunteers can gain access to promising drugs and medical devices long before they are approved for the marketplace. The product is typically supplied to the volunteer at no charge and there is usually no charge for study-related exams, tests and procedures.
Some people volunteer because they enjoy being at the forefront of new technologies. Others participate for humanitarian reasons—helping to gather information on diseases, drugs and medical devices that could potentially impact the lives of millions of people. Each person must decide if enrolling in a clinical study is right for him or her.
Who Pays For Clinical Trials?
Clinical research is funded by both the government (through the National Institute of Health) and by private drug and medical device manufacturers. The institution paying for the research is called the sponsor. The sponsor hires physicians to conduct clinical trials, who are usually paid on a per-patient basis. The sponsor pays the physician to gather information about the drug or device by performing study-related exams, tests and procedures.
A volunteer’s usual and customary medical exams, tests and procedures not related to the study are paid for by the volunteer or other third-party payer (such as an HMO, insurance company, or Medicare), just as they would be if the volunteer was not in a clinical trial. All tests, procedures and exams that are being done just for the trial, and are not part of normal treatment, are paid for by the sponsor.
Your doctor will be glad to discuss participation in clinical trials and answer any questions you have.