Inside Duke Medicine

New Duke Clinical Research Unit to conduct groundbreaking translational research

While Duke University Medical Center has been at the forefront of translational research developments, this month’s opening of a state-of-the-art clinical research facility will further position Duke as a leader in transforming patient care by informing how diseases are diagnosed and new drugs and treatments are discovered and developed.

The newly-expanded Duke Clinical Research Unit (DCRU) will become one of just a handful of hospital-based, early phase research units in the United States for the clinical development and evaluation of investigational drugs and medical devices, as well as providing a new way of studying a wide range of emerging – and longstanding – medical research questions.

“It is our hope that this unit will serve as a model in the field of proof of concept and early phase research and will play a unique and innovative role in bringing new therapies to patients around the world,” said John McHutchison, M.D., program director of the DCRU. “In particular, we hope the unit will serve as a cutting-edge, flexible, efficient, and user-friendly resource to assist all Duke investigators in advancing their own research goals.”

The unit will offer a “one stop shop” for investigators by providing an environment for intensive early phase research, including studies requiring long confinement periods, while integrating informatics, biostatistics and study design expertise.

“The established clinical trials process is in need of an overhaul as evidenced by the long development process and the unacceptably high number of treatments found to be detrimental, even after they reach the market,” said Rob Califf, M.D., vice chancellor for clinical research. “The application of a novel systems biology and molecular medicine approach to early phase studies represents the kind of innovation that could result in much-needed fundamental change.”

The DCRU will apply a variety of cutting-edge “-omics” (genomics, proteomics and metabolomics) technologies, as well as advanced imaging, cell therapy, biobanking, immune monitoring, and one of the world’s only EchoMRI systems, to measure the physiological effects of medical interventions and better understand the biological causes of diseases or conditions.

The unit, located in the Duke Clinics Building, features specialized facilities for both adults and children, including a 30-bed 17,000-square-foot adult unit and a 13,000-square-foot pediatric unit with six confinement beds and two infant family rooms.

In the case of investigational drugs or devices, the unit is uniquely able to generate a more intensive and broader array of data at the initial proof of concept or “first in human” stage of clinical development than is currently available in traditional early phase studies.

In addition to assessing the viability of new drug and device candidates, the DCRU will be able to conduct studies that could range from those designed to identify and validate novel biomarkers of disease to studies that can shed light on the biological processes involved in certain everyday activities or behaviors associated with medical risks.

Research will be conducted in collaboration with a host of partners, including the pharmaceutical and medical device industry, foundations and government entities.

One of the first studies already underway in the DCRU is a National Institutes of Health-funded study designed with the goal of personalizing aspirin therapy and ultimately enhancing aspirin’s ability to prevent heart disease and stroke. Millions of people use aspirin to protect their heart, yet doctors have no way to accurately identify those who are receiving the drugs beneficial effect to prevent a heart attack or stroke.

“In addition to opening a new door to faster and more accurate clinical research, we will be tackling research questions that have been overlooked and unanswered for decades,” Califf said. “After 100 years of use, Geoff Ginsburg, M.D., Ph.D., is leading a study to better understand aspirin’s effect on the body and optimal dosing.”