What is a clinical trial or study?
This is a research study with human volunteers to answer specific health questions. It is the best way to evaluate drug effectiveness and safety in a controlled environment. The FDA requires all medications be tested before they can be prescribed by a physician.
How does a drug get approved by the FDA?
Drug companies must spend a considerable amount of time and money evaluating new drugs on at least 2,500 people. New drugs must be proven safe and more effective than a placebo (sugar pill).
How much does it cost?
In most clinical trials, the study medication, testing, medical examination and consultation are provided at no charge.
Will I be compensated for my time and expense?
Most trials do compensate participants for their time and effort.
What is informed consent?
This is the process designed to give volunteers the information they need before participating in a study. We discuss the requirements, risks, and potential benefits of the study and ask you to sign a document that records your willingness to participate in the study. We will answer all of your questions until you feel comfortable with your decision.
How long will the study last?
Every study has different requirements. Some studies can involve a single visit while others may involve many visits over several months.
What happens during a study?
This can vary greatly depending on the type of study being conducted. It may include lab work, physical examinations, EKG, osteoporosis scan, cardiac scans and/or endoscopy—all at no charge. Symptoms, lab results and response to treatment are monitored very carefully. You will receive personal attention from our staff who will review all of your results with you.
Are clinical studies safe?
Volunteer safety is the number one priority for all clinical trials. Before a treatment is tested on people it is thoroughly tested using various laboratory techniques. The Food and Drug Administration has established rules to govern participant safety. An Institutional Review Board must approve study procedures before a clinical trial can begin.
What if I decide I no longer want to participate in the study?
Your participation is voluntary, and you are always able to leave a study at any time. If you are having concerns about your participation, please contact your coordinator or other staff member to discuss your concerns as soon as possible.