September 17, 1999

Clinical Trials Center eases path to sponsored-research success

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School of Nursing students (from left) TaCharra Woodard, Thomas Martin and Sandy Riveria were on hand at at recent luncheon held in honor of the incoming class of minority students.

Clinical Trials Center eases path to sponsored-research success

Vanderbilt has established a central office to assist faculty investigators with all aspects of commercial and government-sponsored drug and clinical studies.

The new Clinical Trials Center (CTC) is designed to foster these types of investigational partnerships to help any faculty member who wishes to, to conduct clinical trials

“Translating biological discoveries into new diagnostic and therapeutic agents is among our important missions as an academic health center,” said Dr. Harry R. Jacobson, vice-chancellor for Health Affairs.

Many would-be clinical trials investigators at VUMC have faced a catch-22.

“You can’t get a clinical trial contract with a drug company unless you have a data coordinator, and you can’t get a data coordinator unless you have a contract,” said Dr. Italo Biaggioni, associate professor of medicine and pharmacology and medical director of the Clinical Trials Center.

“There are a handful of outstanding examples within our faculty of investigators who are very successful in clinical research, but it typically has taken a substantial amount of time and effort on their part to get started. We believe there are a lot more faculty who want to do clinical trials, but who may be put off by some of the more laborious requirements.”

Faculty involvement in clinical trials has declined nationally. While 49 percent of Vanderbilt clinical faculty have active clinical research protocols, only 13 percent are doing clinical trials. Biaggioni said the relative lack of speed associated with clinical trials at academic medical centers has led to reliance on private physicians as clinical trial investigators. The Clinical Trials Center aims to increase participation in commercially sponsored research from 13 percent to 20 percent of VUMC clinical faculty.

The CTC was formed in part through committee efforts led by Dr. Julia A. Breyer Lewis, Dr. Kathryn M. Edwards and Patricia R. Hebert, Ph.D.

Lee E. Limbird, Ph.D., associate vice-chancellor for Research, says the goal behind development of the CTC is nothing short of the advancement of medicine.

“When clinical trials are done in the context of an academic center, even the ‘no’ answers to a specific trial become the source of new research and consideration of new hypotheses. When these studies are done entirely in the private sector, the ‘no’ data often never gets described or discussed, and the possibility of discovery based on entirely unexpected findings is diminished, if not eliminated.”

Services of the Clinical Trials Center include matchmaking between sponsors and investigators, cost estimates and budgeting, contract negotiations and agreements, Internal Review Board (IRB) processing, patient recruitment and study coordinators (i.e. research nurses).

“Our mission includes tackling problems common to clinical researchers, such as development of data bases to aid in recruitment efforts, or decreasing the time needed to negotiate a contract and get IRB approval,” said Patricia R. Hebert, Ph.D., associate professor of Preventive Medicine and clinical director of the CTC.

“The quality of research depends a lot on the data coordinators,” Biaggioni said. “We can also help with all the red tape and legal issues. For example, there’s an art to writing consent forms that patients can understand. We have writers that can do this for investigators. We can even offer space for seeing patients.”

Located in the Village at Vanderbilt, the center currently employs four research nurses and one data coordinator, and will add more staff as needed.

The CTC will not be competing with the specialized clinical trials units already established or yet to be established within various divisions of VUMC. The CTC can, however, ensure the efficiency of trials by providing data coordinators and other support to accommodate busy periods.

“We’re very excited about the advent of the Clinical Trials Center,” said Dr. Eric G. Neilson, Hugh J. Morgan Professor of Medicine and Cell Biology and chairman of the department of medicine. “This is a very important resource for doing the specialized studies that a diverse institution would want to have done. It would be my hope that every clinician educator in our department would have at least one, possibly two, active clinical trials. This new support ought to help change the perception on the part of many physicians that they don’t have time to participate in clinical trials.”

Dr. Thomas P. Graham Jr., professor and interim chair of Pediatrics, noted significant new opportunities for faculty participation in clinical trials due to such circumstances as new requirements that drug companies test the efficacy in children of any applicable new drug.

“I would hope that we would double or triple our activity and that all divisions would find paths to clinical trials that would be fruitful. Having this improved infrastructure should help.”

The CTC is already earning plaudits from investigators. A recent study by Dr. Kathryn M. Edwards, professor of Pediatrics, had CTC data coordinator Christine Falcone coming into the hospital nights and weekends to screen and recruit pediatric pneumonia admissions as subjects for an antibiotic trial. The CTC also handled budgeting and wrote the patient consent form.

“They jumped through the hoops so that I didn’t have to,” Edwards said, “I couldn’t have done the study without their help.”

Dr. Mark L. Wolraich, professor of Pediatrics, also strongly recommends the services of the CTC. For a recent study treating attention deficit hyperactivity disorder, the CTC provided Wolraich with staffing and took care of all paperwork. “I don’t think we could have done it without their help.”

“I’d like to emphasize that we’re not forcing anyone to use the Clinical Trials Center,” Biaggioni said. “We’re here if they need us. The idea is to get people started, and if they eventually want to develop their own clinical trial units, nothing would please us more.” For more information, contact the Clinical Trials Center at 3-1787 or at