Neuroscience Clinical Trials Network Includes UC, Cincinnati Children's

CINCINNATI—The University of Cincinnati (UC) and Cincinnati Children’s Hospital Medical Center, joining forces in a collaboration of clinical research programs, have been selected as a clinical site for a national "network of excellence” designed to enhance the quality and efficiency of neuroscience clinical trials.

The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), was established by the National Institutes of Health’s (NIH) National Institute of Neurological Disorders and Stroke (NINDS). It consists of 24 clinical sites in addition to Cincinnati—all academic medical centers—including Emory University in Atlanta, the University of Pittsburgh and Washington University in St. Louis.

The Cincinnati collaboration, known as CinciNEXT, will receive $2.2 million over seven years to administer and staff its site, which will have one full-time coordinator from UC and one from Cincinnati Children’s.

Co-principal investigators are Pooja Khatri, MD, associate professor of neurology, and Tracy Glauser, MD, professor of pediatrics and neurology and associate director of clinical, translational, outcomes and health services research, Cincinnati Children’s Research Foundation. Glauser was also selected as one of three clinical site PI representatives to the NeuroNEXT Executive Committee (a rotating position).

With its national network, NeuroNEXT will have the capability to enroll more patients in larger trials than each center operating individually, Glauser says, facilitating the sharing of information.

"Future advances in the treatment of children and adults with neurological disorders will come from large collaborative multicenter studies,” he adds. "Participation by the University of Cincinnati and Cincinnati Children’s Hospital Medical Center in the NeuroNEXT network will ensure that we will play a pivotal role in the development and testing of new and innovative neurological therapies that will help adults and children both here and around the world.” 
  
"The idea is for the network, through a standardized infrastructure, to be much more efficient than your average set of clinical sites,” says Khatri. "With increased efficiency, the network will be able to provide more rapid preliminary testing of new treatments.”

NeuroNEXT, for example, will use standardized master trial agreements and a central Institutional Review Board (IRB). In addition to the multiple clinical sites, there is one Clinical Coordinating Center (at Massachusetts General Hospital) and one Data Coordinating Center (at the University of Iowa).

"Part of our job will also be providing a liaison and overseeing the neuroscience clinical trials that are occurring at UC,” Khatri says. "So it will be a way to build some cohesion for all the neuroscience and NIH activities that we currently have.”

Khatri specializes in stroke and is the director of acute stroke care for the Greater Cincinnati / Northern Kentucky Stroke Team, while Glauser specializes in epilepsy and is the director of the Comprehensive Epilepsy Center at Cincinnati Children’s. NeuroNEXT will also seek to enhance clinical trials for such neurological disorders as Parkinson’s disease, multiple sclerosis and autism.

"This will be an excellent opportunity for UC and Cincinnati Children’s to build on each other’s strengths,” says Khatri. "With the support of Cincinnati Children’s and the Dean’s Office at the UC College of Medicine, we have been able to create a larger infrastructure for the Cincinnati site.”