CTSA News

“Georgia CTSA Clinical Research Centers (GCRCs) gave me the support, knowledge, and peace of mind that things were done right,” says Vandana Dua Niyyar, MD, Professor of Medicine at Emory and Site Principal Investigator for the TwoPlus Trial. Over the past year, her team has partnered closely with the GCRCs to build the regulatory and operational backbone needed for Emory’s participation. TwoPlus is a multicenter, randomized study comparing an incremental start to hemodialysis — twice weekly plus supportive medications for eligible patients — with conventional thrice-weekly care to reduce treatment burden while maintaining safety and effectiveness. “They even stepped in during a coordinator gap so the study could keep moving,” Dr. Niyyar adds.  

How GCRCs Make Emory’s Participation Possible

From IRB modifications through day-to-day conduction of the study, the Georgia CTSA Clinical Research Centers (GCRCs) at Emory provide operational and regulatory backbone for one of the nine sites in the TwoPlus Trial. “At different points in the timeline, GCRC has supported the primary research coordinator in all aspects of the study implementation - from the IRB modifications to pre-screening, enrollment, conducting visits, and data entry,” notes Xu Wang, PhD, Clinical Trials Manager. The team also runs weekly safety reviews with the site PI, Dr. Vandana Dua Niyyar, to monitor labs and vitals and properly report adverse events. “It’s truly a GCRC-supported trial,” adds Wang.

On the ground, Rendy Chaparro, MD, Senior Research Specialist, says GCRCs streamlined recruitment across multiple dialysis centers by refining record reviews and inclusion/exclusion checks with the PI — a key factor in improved enrollment.  

Impact of the GCRCs

Wang remarks, “This trial would not be running this smoothly or recruiting this many participants this quickly without GCRCs support.”  

Dr. Niyyar underscores why this matters to investigators, “As a physician first and an investigator second, you don’t want things to fall through the cracks. Having trained GCRC staff ensures the regulatory and organizational pieces are in place so I can focus on the patients.” She adds, “It’s not just the structure, it’s the people. They got us through a tough period when we were between coordinators so the study could keep moving.”  

Emory has since built momentum: the site is now among the fastest-enrolling in the country — a credit to the coordination between the GCRC and investigator teams.  

What This Trial Means for Patients

For participants, the possibility of starting with two sessions per week is immediately meaningful. “When we tell them there’s a study that may offer twice-a-week dialysis, they are very excited — it’s one less day they have to spend at the dialysis center,” says Dr. Chaparro.  

About Georgia CTSA Clinical Research Centers

Georgia CTSA Clinical Research Centers (GCRCs) are Georgia CTSA’s multi-site clinical research infrastructure, providing investigators with coordinator services, nursing support, a core laboratory, and dedicated inpatient/outpatient research space, plus the regulatory and operational expertise needed to launch and sustain complex clinical trials. By pairing experienced staff with proven processes, the GCRCs help teams translate innovative ideas — like TwoPlus — into studies that run smoothly and improve patient care.