Carolina Data Warehouse for Health Improves Recruitment for Diabetes Clinical Trials

Recruitment for clinical trials at the UNC Diabetes Care Center (DCC) is now easier and more effective, thanks to the Diabetes Care Center Data Mart, a database developed by a team involving the Carolina Data Warehouse for Health (CDW-H). Prior to its development, every clinical trial required a separate search for potential participants based on each trial’s specific protocol. With the new database, clinical research coordinators have data on 50,000 patients, which they can more easily search and filter on 27 clinical parameters commonly used in clinical trials.

Michelle Duclos, clinical trial manager at the DCC, says she uses the database in two ways: (1) to recruit patients for a specific clinical trial and (2) to assess whether they should take on a particular research study in the first place. That is, she searches to see whether there are enough potential patients who meet the study’s enrollment criteria. For example, she recently used the database to enroll 22 of 30 patients needed for the DCC’s quota as part of a large, world-wide, multi-site trial involving 9,000 patients total.

“Believe it or not, that is phenomenal,” said Duclos. “This data set has given us an opportunity to reach those patients that we don’t personally see in our own clinic population.” She added, “I’ve taken on research studies that I would not have previously.”

Each week, the CDW-H automatically feeds new data into the Data Mart from its storehouse of data collected from patient encounters with UNC Hospitals and through its billing system. In addition, the CDW-H provides technical support for studies involving the data. The CDW-H is a joint service of the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and UNC Health Care. NC TraCS is home to UNC’s Clinical and Translational Science Awards (CTSA) from the National Institutes of Health, which develops programs and infrastructure to accelerate the movement of research discoveries into patient therapies. Emily Pfaff, research analyst at NC TraCS, did the technical and data work to develop the Data Mart.

“Both our research volunteer registry and the Diabetes Data Mart were developed based on information and collaborations facilitated through UNC’s NIH Clinical and Translational Science Awards (CTSA) program, particularly the Bioinformatics Core, the Regulatory Core and the Clinical and Translational Research Center (CTRC),” said John Buse, M.D., Ph.D., executive associate dean for clinical research, UNC School of Medicine, and director of the UNC Diabetes Care Center. “These tools now account for the majority of our patient recruitment and have enabled us to take our research unit to the next level in funding and activity.”