Clinical Research at CCC
Clearwater Cardiovascular Consultants is a private cardiology practice that conducts numerous FDA regulated investigational medical studies in hopes of assisting with approval for new treatment options in cardiology. These studies are sponsored by pharmaceutical and device companies, as well as government and educational institutions. Clinical Research Studies are conducted as part of the process of obtaining FDA approval for new medical treatments, so that they can be used by the public safely and effectively.
The CCC physicians have had a dedicated Clinical Research Department since 1992. Research studies are conducted at all 3 office locations as well as at local hospitals. The commitment to clinical research has provided CCC physicians with the ability to provide their patients with the most current and powerful treatments available in cardiology today. The department is staffed by a highly trained, experienced team of full-time clinical research nurse coordinators and support staff who place patient safety and care as their number one priority.
Research studies rely on volunteers to test these new investigational treatments. In order to be eligible to participate in a study, volunteers must meet specific criteria. The criteria help to focus the specific medical population being studied, minimize variables and provide patient safety. Clinical research study volunteers assist in the advancement of science and help develop medical therapies that may someday offer better treatments for future cardiology patients. At CCC, we consider our research study volunteers to be medical heroes.
CCC Research Doctors
All of the doctors at CCC actively support the clinical research studies conducted at CCC. Some of the physicians take on the added responsibility of being Principal Investigators. A Principal Investigator is a physician who takes responsibility for the overall management of the study at a site. CCC also has a Research Steering Committee comprised of several CCC physicians. The committee meets monthly to review studies for scientific merit, safety and relevance to cardiology, the practice and our patients.
CCC Research Staff
The CCC Clinical Research Team is committed to conducting clinical research at a high quality level with a professional, knowledgeable and friendly approach. All CCC physicians are trained Clinical Research Investigators with many years of experience. Physician Investigators are members of our Research Steering Committee which meets routinely to discuss clinical research at CCC.
The Clinical Research Coordinator (CRC) is the primary contact for research volunteers. Here at CCC, all of our coordinators are also experienced in cardiology practice. Many of them have advanced degrees and maintain credentials as certified clinical research coordinators.
A full time Regulatory Coordinator supports the CRC staff by ensuring that studies are conducted ethically and within the FDA and Good Clinical Practice guidelines. Research Assistants provide non-clinical support which allows the CRC more time to be with patients.
A full time Director of Clinical Research oversees all department activities and is responsible for the clinical and administrative duties associated with conducting clinical research studies.
At CCC, the Research Team is continually seeking patient volunteers for clinical trials. CCC has a state of the art electronic medical record system that gives the Research Team the ability to identify patients that have the disease process being studied. When a patient is identified as meeting the criteria for one of the studies, the primary cardiologist is contacted for permission to contact the patient. The cardiologists on staff will also provide direct patient referrals to the Research Team. The Clinical Research Nurse Coordinator contacts the eligible patient, and gives them a brief description of the study and then asks if they are interested in coming to the office for a screening visit.
At the screening visit, the patient is given a very detailed explanation of the study requirements, a thorough review of the medical history is conducted to be sure they meet all of the qualifications, and all questions are answered. The patient is always encouraged to bring family and friends to this visit. If a patient agrees to participate, they are asked to sign an Informed Consent. The patient may also begin research activities such as baseline blood draws and be dispensed study medication at this visit. A follow up visit is scheduled.
Participating in a clinical research study is ALWAYS voluntary.
People volunteer for clinical trials for a variety of reasons, some of which may include:
- Taking an active role in your own healthcare.
- Gain access to investigational treatments that are not available to the public.
- Obtain free expert medical care at leading healthcare facilities during the trial.
- Help others by contributing to the advancement of medical treatments in cardiology.
Next Clinical Research Resource Links
The CCC Research Team is always trying to find helpful sites on the internet to provide you access to information. We do not endorse any of these links, but provide them to you for information purposes only.
Center for Disease Control and Prevention