What is a clinical trial?
Any time that a new medication or device is introduced to the public it must first undergo an extensive period of time where the safety and effectiveness can be measured. This is known as the clinical trial or research trial. These trials are essential to the development Clinical Trials of new medications and devices that are used to treat, prevent or diagnose diseases.
There is a group of people (medical professionals as well as lay people) who are responsible for ensuring that the rights and safety of these patients are protected. This group is called an Institutional Review Board. Their sole job is to review these clinical trial protocols and determine safety and protection of privacy. Before any physician can become part of a clinical trial they must first be approved by the Institutional Review Board.
Who can participate in a clinical trial?
Each clinical trial is attempting to answer certain questions about the study drug or treatment. Therefore, each trial has a specific set of guidelines that each patient must meet before becoming part of the trial. There may also be certain criteria that would exclude people from the trial.
What is involved in participating in a clinical trial?
If you are interested in participating in a clinical trial the first step is to let one of our physicians or staff members know. If we have a trial that you would qualify to enter, our research staff will educate you on the purpose of the trial, what procedures would be involved, frequency of hospital or office visits, and the potential risks and benefits involved with participating in the trial. Once all of your questions have been answered to your satisfaction, you would then be asked to sign a consent form. Always remember that your participation in a clinical trial is voluntary and may withdraw at any time.
How do you benefit?
While no direct benefit from study drug or treatment is promised, the following are a few potential benefits for participating in a clinical trial:
- The study drug or treatment may be provided at no charge to you
- Study related lab tests or procedures may be provided at no charge to you
- You may have the opportunity to be involved with a new medication or treatment that is not available to the general public
- You are helping gather valuable information on new medications or treatments that may benefit you and others in the future
If you have any further questions, please ask to speak with our research team here at Comprehensive Cardiovascular Medical Group.