Pre-clinical studies

Before pharmaceutical/device companies start clinical trials on a drug or device, they conduct extensive animal experiments using wide-ranging doses/ devices to obtain preliminary efficacy and toxicity data.

PHASE I

Phase I trials are referred to as ‘first in humans’. These trials are the first dosage of study drug tested in human subjects. They are designed to test the safety, side effects, dose, and efficacy for the drug. A small group of subjects 2-50 healthy volunteers will be recruited for Phase I.

PHASE II

Once a dose or range of doses is determined, the next goal is to evaluate whether the drug is safe and effect. Phase II trials will recruit between 100 and 300 subjects on average.
Phase II studies are sometimes divided into Phase IIA and Phase IIB. Both studies look to find the optimum dose at which the drug shows effectiveness with minimal side-effects.

PHASE III

Phase III, is designed to assess the effectiveness and safety of the new intervention. Phase III studies are randomized, controlled, large patient groups of 300–3,000 or more and are aimed at being the definitive assessment of how effective the drug is, in comparison with current standard of care.

PHASE IV

Phase IV trials, are also known as postmarket surveillance trials. They involve the safety surveillance and ongoing technical support of a drug after it receives permission by the FDA to be sold.

Clinical studies are an integral part of clinical research. They are at the center of all advances in modern medicine and offer hope for many people. Participants in clinical studies gain access to new research treatments and help others.

Who Can Participate In A Clinical Trial?

All clinical trials have protocols detailing who can participate in the program. Eligibility is determined by assessing age, type of disease, medical history and current medications. Your cardiologist and clinical research coordinator will speak with you to determine your eligibility. Your will be given an informed consent to read and discuss with your family members. The cardiologist and clinical research coordinator will be available to answer any of your questions or concerns.

What Happens During A Clinical Trial?

Your cardiologist and research coordinator will follow your progress throughout the trial. Some trials require EKG’s , Echocardiograms, Lab collection, peripheral vascular studies to name a few. A detailed description of each study visit will be explained within the informed consent.

Are you Interested in Participating in a Clinical Research Trial?

Call our Research Department at 561-537-4778