Biostatistics research recognized as ‘Top 10’ by Clinical Research Forum

April 27, 2015

The Collaborative Studies Coordinating Center (CSCC), housed within the biostatistics department at the UNC-Chapel Hill Gillings School of Global Public Health, is the data-coordinating center for the Randomized Intervention for children with Vesicourteral Reflux (RIVUR) trial that recently received a Top 10 Clinical Research Achievement Award for 2015.

The awards, presented by the Clinical Research Forum, were announced April 21 in The Washington Post. The CSCC’s work was instrumental to the winning paper, titled “Antimicrobial prophylaxis for children with vesicoureteral reflux,” published online June 25, 2014 by The New England Journal of Medicine.

“I’m glad to have contributed to the excellent research from our School and department,” said Myra Carpenter, PhD, senior investigator at the CSCC and principal investigator of the RIVUR Data Coordinating Center.

“Frequently, our research infrastructure is overlooked, and this project’s success is due in part to the awesome research environment at the Gillings School, its Department of Biostatistics and especially the Collaborative Studies Coordinating Center — each facilitated our successful collaboration on this project.”

The RIVUR trial was designed to evaluate pediatric antibiotic use for preventing recurrent urinary tract infection (UTI) and kidney scarring in children with vesicoureteral reflux (VUR). Children aged two through 71 months were enrolled in the trial at 19 pediatric clinical sites across the United States.

The RIVUR trial provided strong evidence that, in comparison to placebo, daily prophylactic doses of trimethoprim-sulfamethoxazole (TMP-SMX) reduced the two-year risk of recurrent UTI in children with VUR. However kidney scarring was rare and did not differ by treatment group.

Perhaps not surprisingly, among those children who did have recurrent UTI, the infecting organism was more likely to be resistant to TMP-SMX in the prophylaxis group than in the placebo group.

“Importantly, prophylaxis was particularly effective for preventing recurrent UTI in children with bladder and bowel dysfunction (BBD), reducing their two-year likelihood of recurrent UTI to approximately one-fifth of that of children with BBD on placebo,” noted Carpenter.

She added, “The role of the CSCC in this project was considerable. We were involved with study design, protocol and form development, data management, monitoring trial progress and quality assurance, data analysis and manuscript development.”

The CSCC team also included Anastasia Ivanova, PhD, associate professor of biostatistics, Lisa Gravens-Mueller, MS, biostatistician/supervisor in the biostatistics department and project manager, and numerous research staff. Colleagues from the UNC-Chapel Hill School of Medicine who participated in trial planning and masked review of UTI outcomes were William Primack, MD, Timothy Bukowski, MD and Richard Sutherland, MD.

“I am very proud of Myra and the CSCC RIVUR team for their outstanding contributions to the success of this trial,” said Sonia Davis, DrPH, director of the CSCC and Professor of the Practice in the biostatistics department at the Gillings School. “The RIVUR study exemplifies CSCC’s history of exceptional collaborative leadership of multi-site public health research studies through study coordination, innovative data management solutions and cutting-edge statistical methods.”