UF studies of new pharmaceutical drugs to expand with opening of clinical trials facility

Testing of new drugs at the University of Florida Health Science Center soon will expand with today’s opening of a $1.9 million building for clinical trials research.

Researchers and health-care professionals from the UF Center for Clinical Trials Research (CCTR) will use the new 48-bed facility to test the safety and efficacy of newly developed prescription medications for pharmaceutical companies. Several companies will sponsor clinical studies at the facility.

“Within the past 14 months, our college has signed more than $1 million worth of contracts for industry-funded clinical studies,” said C. Craig Tisher, M.D., interim dean of UF’s College of Medicine and medical director of the CCTR. “We have enough studies already lined up to keep the new building operating at full capacity for several months to come.”

The 13,353-square-foot building—the largest freestanding clinical trials unit at a U.S. university—is designed for the comfort of study volunteers (subjects) and the efficient supervision of clinical studies, making it competitive with privately sponsored facilities.

Phase 1 and phase 2 clinical trials (aimed at evaluating safety and effectiveness) will be conducted in the building.

Located less than a mile west of the Health Science Center on Archer Road, the one-story structure has two identical wings with a central nursing station designed for easy monitoring of subjects, a laboratory for processing body fluid samples and physical examination rooms. The building also is equipped with a self-contained generator that will run for 21 days in the event of a power outage.

The facility’s home-like interior provides a comfortable environment for study subjects. A common great room is furnished with couches, a pool table and Internet stations. A washer and dryer are available to subjects staying for an extended period of time.

The building also is designed to protect the security of study participants; to ensure adherence to research protocols; and to safeguard tissue/fluid samples, drug products and data collection.

Entrances to the building, and to the nursing station, laboratory and examination rooms, will be locked at all times. Investigational drugs will be stored in locked cabinets in a locked room, as required by the Food and Drug Administration.

Depending on the drug being studied, subjects will stay at the facility from 48 hours to 30 days. All subjects will be required to sign an informed consent after being briefed on the risks and potential benefits of the drug being tested, as well as the study protocol, and they will be paid a stipend for participating.

After a drug is administered, blood, urine and stool samples may be collected to determine where the drug is going, and what organs and tissues it may be affecting. Sophisticated instruments may be used to monitor a subject’s heart rate and other vital signs. In early stage clinical studies, subjects are observed closely for side effects such as headache, nausea or skin irritation.

“Our job is to monitor what these new drugs are doing in the body,” said Constance Stone, D.M.D., director of the CCTR. Investigational drugs usually go through three phases of clinical testing before gaining FDA approval.

Pharmaceutical companies rely on clinical trial research centers to test the safety of newly developed medications. CCTR administrators and staff members will help the pharmaceutical companies design the clinical trials, and submit study protocols to the Western Institutional Review Board for evaluation and approval. They also will recruit research directors and subjects for the studies.

“The vast population that UF’s Health Science Center and Shands HealthCare serve enhances our efforts to recruit a variety of subjects from around the state of Florida and beyond,” said Robert Thompson, director of clinical operations, and marketing and client services for the CCTR.

The facility was built by M.M. Parrish Construction Co. of Gainesville, and designed by Jack Ponikvar of Ponikvar and Associates Inc.

For more information on current clinical trials, call the CCTR at (352) 395-0763.