What is a clinical trial?
A clinical trial is a research study that is conducted in a medical setting. It involves the testing of a new medication, treatment, or device that is not yet approved by the Food & Drug administration (FDA) for routine use. The purpose of such studies is to determine if a new medication, treatment, or device is safe and effective. All medications and treatments in use today were first tested in a clinical trial. Some clinical trials explore if drugs or treatments already available in pharmacies are effective for diseases other than for which they were initially approved.
How can you enroll in a clinical trial
and what to expect?
Choosing to enroll in a clinical trial is a personal decision that requires careful consideration of the potential risks and benefits of participation. The doctor or a nurse involved in the trial will explain the details to you so you can decide whether or not you wish to participate. An initial appointment with our physician is necessary to determine whether or not you are a candidate for a particular clinical trial. Once an evaluation is made, a consent form will be explained to you and your signature obtained as an acknowledgement of your understanding. This is essential before any volunteer is enrolled in any clinical trial. This document is not a contract, and you may withdraw from the trial at any time.
What information do you need to decide whether or not to volunteer for a clinical trial?
Questions you need to ask:
- What is the purpose of the study,
- How long the study will last,
- What procedures will be done as part of the research study,
- Potential risks or discomforts that may be associated with these procedures, including additional treatment costs, if any,
- What other treatments are available should you not decide to participate in the study.
Are investigational treatments better than currently available ones, and are they safe?
Clinical trials are done with the hope that the new treatment will be as effective, or more effective than currently available treatments, but this is not known. By definition, if we are conducting a study, it is because we do not know the effectiveness. Clinical trials are designed with safety in mind, and known risks are explained in the consent form. However, there may be risks that are not known at the time the study is started.
CLINICAL TRIALS
We are currently enrolling patients in several clinical trials. If you are interested in taking part, please call (615) 843-7546 for more information.
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