What is Clinical Research

Clinical Trials are designed to answer a question about disease. In addition to direct clinical examination, it includes the study of blood. In general, trials test the safety and effectiveness of drugs and devices.

Clinical Research is the process utilized to gather data to provide the required information necessary for the FDA to determine if a drug or device will receive approval to market.

The Heart and Vascular Institute currently participates in Phase II, III and IV trials.

            Phase II Trials:

-    Investigational drug is first tested in the human population

-    Patients have the disease being treated

-    Usually a smaller trial with several hundred patients

-    Looks at the safest dose of the drug to be given

Phase III Trials:

-    Investigational drug is tested in a larger population often hundred to thousands of patients.

-    Testing how the Investigational drug compares to a control group (another drug or placebo).

-    The last step of testing before the sponsor of the study submits all their data to the FDA for approval.

Phase IV Trials:

-    Trials for after the drug has been approved by the FDA

-    Usually very large trials with thousands of patients

-    Data is collected to test the long term safety of the drug for patients, these trials generally last 5+ years.

-    Is the drug safe in the general population?

Participating in clinical research is a voluntary decision and we want to make sure you are informed. When you are interested in a trial all the study information will be discussed with you including all the trials risks, benefits and alternative treatments available. We encourage you to discuss the trial with your family and your Primary Care Physician.

With your approval, we are able to send your other treating physician information regarding your enrollment in a clinical research study for your records. We are also able to share any lab work or procedure results you acquire while in the study.

Research can provide an alternative treatment choice when considering your options. The study drug and/or device is often provide to you at no cost along with the opportunity to have additional testing and procedures that may not be available with your standard of care.

Research appointments are made to fit the time needed to accomplish the studies requirements and creates a great opportunity to develop a relationship with our practices Research Nurse who will be monitoring your whole medical history while in the study.

These appointments are great opportunities to discuss your Medical history. These study visits are a great teaching/learning environment to discuss your cardiac health with review of diet, exercise and coronary artery disease prevention.

Your participation in Research can be withdrawn at any time with no penalty to you or your ongoing care with our practice.

If you have additional questions regarding Clinical Research please contact our research department at (727) 489-2552.