August 8, 1997

VCC’s fast-growing Clinical Trials Office gets more space

VCC's fast-growing Clinical Trials Office gets more space

The Vanderbilt Cancer Center's Clinical Trials Office has moved to a larger home to accommodate a growing staff and to better support more studies of cutting-edge cancer therapies.

It has been a little more than a year since the Clinical Trials Office was established as an important "shared resource" for VCC investigators. Since that time, the staff of research nurses, data managers and support personnel has doubled to 23 full-time and three part-time employees, said Debra Wujcik, R.N., M.S.N., A.O.C.N., clinical director for the Clinical Trials Office.

"Having a more organized approach to clinical trials enables care to go more smoothly," Wujcik said. "It allows us to support more investigators and offer more clinical trials.

"Patients will have more studies available for different disease types, and there will be more phase 1, cutting-edge trials for patients who have exhausted other therapies or for whom there's not a good standard therapy. It's exciting to be able to offer new hope that wasn't there before."

The Clinical Trials Office is now located in more than 6,000 square feet at 2611 West End Ave., next door to the Cooker restaurant. The move freed up several hundred square feet in Medical Oncology for physician offices and patient care.

In addition to a growing staff, two new positions have been created to help meet the VCC's mission as a National Cancer Institute center: a protocol development liaison, filled by Kelly Willenberg, R.N., B.S.N., and a cancer information specialist, filled by Teresa Knoop, R.N., M.S.N., A.O.C.N.

"The protocol development liaison is a nurse with research experience who works with investigators from the idea stage through development of a study until enrollment opens," Wujcik explained.

"The cancer information specialist's job is to provide information to patients about clinical trials and specialty services at VCC. As a master's level nurse, she also uses her expertise to screen patients for studies and refer them to specialists."

Teams of research nurses and/or data managers are assigned to Medical Oncology, Radiation Oncology, Surgical Oncology and the Veterans Administration Medical Center on days when cancer patients are being seen, Wujcik said. Two nurses and a data manager are also assigned to the cancer clinic at St. Thomas Hospital.

"When a patient is offered a clinical trial, the person who is best able to do that is right on site," Wujcik said. "We're able to get patients through the paperwork and onto treatment more quickly."

Clinical Trials Office staff are available to assist any of the more than 100 investigators in the VCC. Their services range from assisting an investigator in submitting an application to the Clinical Protocol Review Committee to managing a study from start to finish, through the Institutional Review Board process, enrollment and data collection, Wujcik said.

Clinical trials, also called treatment studies, are a key step in the development of new drugs and therapies. All drugs we take and all medical treatments we undergo have been through this process.

Cancer treatment studies have been conducted at Vanderbilt University Medical Center for many years, but with the designation of the VCC as an NCI cancer center in 1995, the nature of treatment studies conducted here has changed.

Studies now often involve multi-modality treatments – chemotherapy combined with radiation, for example – and thus involve staff in several departments or divisions.

"So there's a need for a coordinator to bridge that gap between departments," Wujcik said. "Our office supports that communication. The same nurse coordinates the study and the patient's care. It offers a better continuity of care for our patients."

NCI centers are also focused on conducting "translational research," studies that move discoveries in the laboratory to the patient in the clinic or hospital as quickly as possible and then take clinical questions back to the lab for further investigation.

Currently, VCC has about 150 cancer treatment studies open. The total number does not differ much from before the establishment of the Clinical Trials Office, but what has changed is the kind of studies and which departments and divisions are conducting them, she said.

Last year, about 97 percent of cancer treatment studies were conducted by investigators in the division of Medical Oncology, but this year, a third have been conducted by Radiation Oncology, Hematology, Surgical Oncology and Neurology, Wujcik said.

"We also have a smaller proportion of pharmaceutical industry-sponsored trials, more studies that are done by cooperative groups, like the Eastern Cooperative Oncology Group, and more trials that are initiated and written by our own investigators," she said.

"We now offer more and more unique, cutting-edge therapies. We're not out to participate in trials that anybody in town can do. We're doing more phase 1 trials, translational trials and investigator-initiated trials because that's our responsibility as an NCI center."

The Clinical Trials Office can be reached at 936-5795. The telephone number for the cancer information specialist is 936-5787.