Frequently Asked Questions
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What is a Clinical Trial?
Clinical trials, also known as research studies are conducted to test the safety and effectiveness of new medications and treatments or to develop new uses for existing medications and treatments. These trials are conducted at approved sites under the supervision of physicians (also called “investigators”) and other research professionals. By participating in a clinical trial, you help in the development of medical advances that can in turn help you, as well as millions of others, by finding better treatments, and even cures, for life-threatening and chronic diseases.
Are clinical trials safe?
The FDA has strict guidelines for conducting clinical trials in all areas of medicine. The FDA requires that all medications and/or treatments be thoroughly tested for safety and efficacy before they can be prescribed by your doctor. The government, pharmaceutical and biotechnology industries have developed standard guidelines that all clinical research sites must follow in order to conduct clinical trials. Audits are performed on a regular basis to make sure these guidelines are being followed. Additional review is done by organizations called Institutional Review Boards (IRB). These boards make sure your rights are fully protected and that you are not exposed to any unnecessary risks.
What happens during the trial?
If you are eligible for the trial, you will be assigned to a specific study group. Depending on the group, you will receive either:
- The investigational medication or treatment
- A placebo (an inactive product that is used to compare the results of the actual medication or treatment)
- An already approved medication or treatment
How will I be informed about the progress of the trial?
Informed consent is an important part of the clinical trial process. Before volunteering for a study, you will be given detailed information about the study to help you make your decision. If you decide to volunteer, you will be asked to sign an Informed Consent form. During the trial, our clinical staff will keep you updated on the progress of the trial. During the trial, you should always feel free to ask questions and expect honest answers from our staff.
Who pays for the trial?
The study sponsor usually pays for all procedures, lab work and medications directly related to the study. One of our Clinical Research Coordinators can give you more information about the study you are considering.
What happens when the trial is over?
Once the trial is complete, all the information is analyzed to determine whether the treatment is effective and safe. From there, Food and Drug Administration (FDA) decides whether to approve the treatment. This process could take many years.
What questions should I ask?
- What is the purpose of the study?
- What kinds of procedures and/or tests will I have during the study?
- How often will I need to go to my doctor’s office?
- What are my responsibilities during the study?
- Are there medication restrictions during the study?
- What are the potential benefits and possible risks?
- How long will I be in the study?
- Will there be any cost to me?
- Is there alternative treatment for my condition?
- Will I learn of the study results?
Will my privacy be protected?
Absolutely. All medical records are kept confidential and the trial data provided to the study sponsors and the FDA will not include your name or identifying information.