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Research at the Center focuses on data collection
for pharmaceutical and device sponsor companies which can be taken
to the Federal Drug Administration to gain regulatory approval. It
is conducted in four phases.
Phase 1 covers feasibility studies and is conducted with healthy
volunteers as subjects.
Phase 2 takes place as experience with a drug grows. First trials
involve safety concerns and are conducted in multiple centers involving
a substantial number of patients.
Phase 3 encompasses large-scale studies in dozens or hundreds of
sites involving thousands of patients. At this level of research,
the drug or device under study might be taken to the FDA to seek
authorization for specific use and indications.
Phase 4 reviews drugs that are already on the market to look at new
formulations of an existing medication or a different way to use
it.
Efforts at the Center concentrate on Phase 2 and 3 type research.
The Sarasota Memorial Health Care System is one of the first nonacademic
hospitals in this country to offer an avenue for clinical studies
to its staff physicians.
A physician is always the principal investigator in a study with
a team of clinical research coordinators (nurses) working closely
with the physician-investigator so that study documentation meets
the highest possible research standards.
