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General clinical research center at Wake Forest University Baptist Medical Center awarded $14.7 million

WINSTON-SALEM, N.C. - The General Clinical Research Center (GCRC) at Wake Forest University Baptist Medical Center, where thousands of area residents have participated in clinical trials or population studies since 1993, has been awarded $14.7 million to continue for another five years.

The new funds represent a dramatic increase over the previous five-year grant, which totaled $9.9 million, according to Diane Q. Mann, GCRC administrative director.

"Our research is general - we conduct studies to benefit the tiniest premature babies to the most senior members of our community," Mann said. "Our studies cover the whole research spectrum from soy and vitamin therapy to sophisticated cancer drug treatments targeted to kill leukemia cells. We've conducted a NASA nutrition study to prevent kidney stones in space, and we've tested inhaled insulin as a painless way to treat diabetes."

The grant, from the National Institutes of Health's National Center for Research Resources, pays for specialized facilities and staff and supports as many as 90 studies at any given time. The GCRC is one of 79 centers nationwide, mostly housed in academic medical centers.

"The funds will allow the Medical Center to continue and strengthen its tradition of providing a premier resource for clinical research, giving patients access to the latest advances in medicine," Mann said. The funds also will permit expansion of the program to:

• Create a molecular genetics core laboratory headed by Donald W. Bowden Ph.D., professor of biochemistry and internal medicine (endocrinology/metabolism).
• Add an associate program director for geriatric research, Jeff Williamson, M.D., who will join current associate program directors Richard Weinberg, M.D., for nutrition, and John R. Crouse, M.D., for core laboratories. Geriatrics studies will be carried out in the Geriatric Research Center, a GCRC satellite in the J. Paul Sticht Center on Aging and Rehabilitation.
• Add a research subjects compliance director, who will be an advocate for the participants, assure the safety of clinical trials and provide related investigator training. Susan Margitic, previously associate director of the Office of Clinical Trials Research, will hold this post and report directly to James N. Thompson M.D., vice president and dean of Wake Forest University School of Medicine and GCRC principal investigator.
• Take steps toward establishing an outpatient pediatric general clinical research center in the new Brenner Children's Hospital.
• Create a research affiliation with the Downtown Health Plaza of Baptist Hospital to make participating in clinical trials easier for patients who get their medical care at that facility. Ramon Velez, M.D., medical director of the facility, will join the GCRC Advisory Committee, which is responsible for awarding GCRC research grants.

"At a time when the use of tax money is being carefully evaluated, it is significant that we have received this large award," said Mann. "It means that we are effectively helping people find new treatments for a wide variety of medical conditions."

"The GCRC provides an engine to foster rapid progression of research into practical applications for improving human health," said Charles E. McCall, M.D., professor and vice chair for research of the Department of Internal Medicine and GCRC program director. "All clinical departments and many basic science departments, as well as centers such as women's health and cancer, use the outstanding facilities of the GCRC."

The GCRC is staffed by a variety of research professionals including nurses, laboratory technicians and bionutrition staff. The facility includes a metabolic kitchen to provide research diets calculated to control a wide variety of nutrients. The center offers computer and biostatistics expertise to investigators.

But not all patients are seen in the outpatient clinic, located in the GCRC Building near Hawthorne Road and Queen Street. Some studies use the GCRC inpatient unit in West Building, and some enlist participants elsewhere such as the adult and neonatal intensive care units.

All GCRC activity is overseen by the advisory committee, which makes awards competitively. The bulk of the grant provides supplementary funding for clinical studies at the center. NIH-supported research has top priority, but studies funded by foundations, industry and other sources also are included. To date the GCRC has conducted 225 research protocols.

Collaborative research among departments is a hallmark of the Wake Forest University Baptist Medical Center GCRC.

"I believe that a key to our success is that we have an exceptional team of professionals who genuinely enjoy working together," said Mann "The friendly atmosphere encourages top investigators to conduct their studies here, and participants often volunteer for new studies because the experience was so positive."

Contact: Robert Conn, Jim Steele or Mark Wright at (336) 716-4587

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