Patients at Shands Jacksonville have the opportunity to get even closer to cutting-edge research thanks to the hospital’s Clinical Research Unit, which offers access to Phase I and II clinical trials.
Clinical trials are real-world test environments for new medical devices, procedures and pharmaceutical products. Unlike Phase III and IV trials, which are later stages of testing involving a greater number of participants and medical facilities, Phase I and II trials are investigations that are fresh out of the laboratory. They require much smaller test groups in a more controlled environment, and are considered highly experimental.
Overseen by Arshag Mooradian, MD, University of Florida professor and chair of medicine, the Clinical Research Unit includes nurses and study coordinators who interact with various medical and pharmaceutical companies to set up local trial sponsorships. The unit proactively contacts appropriate physicians to gauge interest and applicability. If a physician agrees to conduct a trial, he or she becomes the primary investigator and the unit collaborates with him or her to administer the product and record the results.
"The CRU is an important link in the process of translating research findings in the laboratory to clinically effective therapies," Mooradian said. "In some instances when the currently available therapies no longer help, the patient will have access to innovative experimental therapy through the CRU."
In cases where intensive monitoring is required, the unit has four beds to accommodate patients. The unit’s nurse manager, Rhonda Calhoun, RN, BSN, said the unit has performed a number of successful trials since its opening a year ago.
"Patients who have exhausted conventional means to combat a medical problem might find an experimental option more viable," Calhoun said.
Shands Jacksonville, which launched the research unit through funding from the UF College of Medicine-Jacksonville and the UF Clinical and Translational Science Institute, is one of a relatively small number of healthcare organizations nationwide that conduct Phase I and II studies.
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