CTRC offers support for patient-oriented research

By Amanda Siegfried

UT Southwestern investigators who are tackling important health issues through patient-oriented research now have access to a centralized and comprehensive set of facilities that provide both physical and staffing infrastructure for conducting clinical studies.

As part of the institution’s efforts to enhance clinical, or patient-based, studies, the Clinical and Translational Research Center provides complete clinical research support to investigators. The CTRC incorporates inpatient and outpatient units as well as dedicated diagnostic and treatment equipment. A highly trained staff of about 25 professionals provides all the resources and expertise needed to fully support most clinical studies.

Carlos de la Peña (standing), clinical research manager, talks with research study participant Timona Patterson after she underwent a DEXA body scan. CTRC dietitian Michelle Negri analyzes the computer scan.

One outpatient clinic is on the eighth floor of the James W. Aston Ambulatory Care Building and the other is on the sixth floor of the Charles Cameron Sprague Clinical Science Building. An inpatient facility, formerly the General Clinical Research Center (GCRC), is at Parkland Memorial Hospital, on 7 West.

Through the CTRC, investigators have access to sophisticated equipment such as a DEXA body scanner, an AccuVein vein finder, a calorimetry machine and a continuous blood glucose monitoring system. They also can tap into an experienced nursing staff to implement study procedures, including administering drugs and infusions, placing and managing intravenous catheters, performing oral and IV glucose tolerance tests, and administering echocardiograms, among many other services.

Other members of the CTRC team include a protocol nurse, a research participant advocate and research study coordinators, all of whom work with individual researchers to develop and implement precise plans for clinical studies. The staff is also “culturally competent,” able to address the cultural sensitivities of study participants who travel to UT Southwestern from around the globe.

“The CTRC is a great example of UT Southwestern’s commitment to clinical research,” said Dr. Scott Grundy, director of the Center for Human Nutrition and the CTRC’s medical director. “We hope the departmental chairs and others on campus will recognize what we have and try to recruit faculty to take advantage of all we have to offer.”

The CTRC is the successor to the GCRC, which was one of several facilities nationwide funded by the National Institutes of Health. In 2006, the NIH launched an initiative called the Clinical and Translational Science Awards (CTSA) program, aimed at improving the way biomedical research is conducted and reducing the time it takes for lab discoveries to become treatments for patients.

Clinical and Translational Research Center Components
Here is a look at what’s available in the three facilities that make up the CTRC:

James W. Aston Ambulatory Care Building, eighth floor — Four exam rooms, infusion suite, two stations for drawing blood and a room for processing laboratory samples. Also provided is office space for nursing staff, office equipment for investigator use and a large patient waiting area. The unit is adjacent to the investigational drug services area.

Charles Cameron Sprague Clinical Science Building, sixth floor — Four procedure rooms and consultation room, investigator resource room, nursing office, patient waiting room, and an area for drawing and processing blood. The unit connects the east wing of Parkland Memorial Hospital to UT Southwestern University Hospital-Zale Lipshy.

Parkland Memorial Hospital, 7 West — A 13-bed inpatient facility offers around-the-clock controlled clinical environment, full metabolic kitchen to assist investigators with nutritional aspects of clinical research studies, and a laboratory processing area that includes centrifuges, freezer and other supplies for preparing and processing lab samples. The unit also has administrative offices, a nurses’ work room and office space for other technical staff.

UT Southwestern received a
$34 million grant from the CTSA program in 2007 and joined a network of CTSA sites nationwide that now includes 46 medical institutions in 26 states. That grant, led by Dr. Milton Packer, chairman of clinical sciences, supports a number of programs aimed at improving clinical research efforts, including the CTRC. The center also receives funding from the medical school.

In addition to supporting UT Southwestern researchers, the CTRC provides resources to other institutions affiliated with the North and Central Texas Clinical and Translational Science Initiative, a consortium formed through a CTSA grant.

In transitioning from the GCRC program, the CTRC has changed focus to cater to the needs of investigators interested in conducting clinical studies, Dr. Grundy said.

Carlos de la Peña, the CTRC’s clinical research manager, describes the CTRC as a service center.

“We listen to the clinical investigators to determine their needs, then tailor our services based on those needs,” Mr. de la Peña said.

One of the needs the CTRC team found was for support outside of the center’s physical facilities. So a mobile research team recently was formed, taking nurses and study coordinators out to emergency and operating rooms to provide services for studies being conducted at those sites.

The CTRC attempts to minimize costs for clinical investigators. For example, clinical research coordinators contracted through the CTRC are billed only for the time they work on a given project, which can save an investigator the cost of hiring a full-time coordinator.

Dr. Grundy said UT Southwestern has a history of conducting clinical studies that have had tremendous impact on health care. For example, researchers in the Charles and Jane Pak Center for Mineral Metabolism and Clinical Research are responsible for developing drugs for kidney-stone prevention, as well as the popular calcium supplement known as Citracal. In addition, investigators with the Center for Human Nutrition were the first to prove the health benefits of the “Mediterranean diet.”

Also, while it’s well-known that UT Southwestern researchers won the Nobel Prize for discovering the basic science of cholesterol metabolism, many might not know that the early development of cholesterol-lowering statin drugs was carried out in clinical research facilities on campus, Dr. Grundy said.

“We now have more capacity than we have users,” Dr. Grundy said. “I think we have much to offer young investigators and the medical center as a whole.”

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Dr. Grundy holds the Distinguished Chair in Human Nutrition and is chairman of clinical nutrition.