Clinical Trials 101

Clinical trials are conducted in medical facilities around the world every day. According to the National Institutes of Health, there are currently 270,894 clinical studies happening in the US and abroad. The Clinical Research Department at FCCI currently houses over 20 clinical trials, placing us at the forefront of medical advancement in cardiology.

What is a clinical trial?
Clinical trials are voluntary research studies that aim to discover new methods for diagnosing, treating and preventing diseases.

How do clinical trials work?
During a clinical trial, participants receive a specific intervention (such as a medication, device implant or procedure) based on protocol that has been established by the research team. However, some participants may receive a placebo, which contains no active ingredients. This helps the researchers determine if the results of the study occurred by chance or because of the test treatment itself.

How do clinical trials help advance medicine?
The goal of a clinical trial is to compare the effects of a new intervention to that of the current standard in medical care. Most clinical trials are used to help researchers discover if a new treatment is more effective than the current medical standard. Additionally, they are also used to determine side effects of the intervention.

Are clinical trials safe?
Although there is some risk involved with any new medical advancement, the US Food and Drug Administration (FDA) along with the Institutional Review Board (IRB) oversee the conditions of each clinical trial to ensure the safety of its participants. Additionally, our Research Department obtains informed consent from participants to help them understand all aspects of a research study, including:

• Purpose and description of the study
• Test, treatments, and procedures to be performed
• Length of the study
• Possible benefits and risks
• Other treatments options
• Privacy protection
• Compensation for participation

What clinical trials has FCCI participated in?
We have been involved in many pre-market stent and drug trials, which have since been FDA approved. FCCI has worked with some of the top manufacturing companies, such as Boston Scientific, Medtronic, Cook Medical, Abbot and other prestigious organizations. “By being active participants in clinical research, we ensure our patients are the first to benefit from exciting new technology in the cardiovascular field,” says Dr. Yazan Khatib, President of FCCI.

Can I participate in a clinical trial?
If you are interested in volunteering for a clinical trial, or would like additional information about the work of our clinical research department, call us at (904) 493-3333.