New national effort to accelerate development of therapies for neurological diseases

The National Institute for Neurological Disorders and Stroke (NINDS) has selected Columbia University College of Physicians and Surgeons and Weill Cornell Medical College to participate in a new national effort to accelerate the development of therapies for people with neurological diseases.

NeuroNEXT (for Network for Excellence in Neuroscience Clinical Trials) links 25 sites through a common research infrastructure, streamlining the process to conduct clinical trials of promising therapies.

"NeuroNEXT promises to be revolutionary. Since investigators spend a great deal of time and effort designing clinical trials and recruiting patients, having an infrastructure in place that can readily support these activities will make all the difference in the world," said Karen Marder MD, MPH, co-principal investigator of the Columbia-Weill Cornell NeuroNEXT site at NewYork-Presbyterian, the Sally Kerlin Professor of Neurology at Columbia University College of Physicians and Surgeons, and a neurologist at NewYork-Presbyterian Hospital/Columbia University Medical Center.

The two medical schools were chosen for their extensive expertise in adult and pediatric neurology, neurosurgery, basic neuroscience, and neuroepidemiology, as well as for their ability to recruit diverse patient populations. In addition, Columbia and Weill Cornell have NIH-sponsored Clinical and Translational Science Award programs, which are designed to promote the translation of laboratory discoveries into treatments. The Columbia-Weill Cornell NeuroNEXT site at NewYork-Presbyterian is supported by a seven-year, $2.27 million dollar grant from NINDS, a division of the NIH.

NeuroNEXT will focus on Phase 2 (exploratory) clinical trials so that researchers can efficiently test new treatments before embarking on large and costly Phase 3 (efficacy) trials.

Twenty-five NeuroNEXT sites will be backed by a central clinical coordinating center, which will help investigators implement clinical trials, and a central data-coordinating center, which will provide statistical and data management support. One innovative aspect of NeuroNEXT is the use of a common institutional review board (a committee to protect the rights and welfare of research subjects). This should significantly decrease the time between trial design and initiation, while ensuring patient safety.

"NeuroNEXT will be open to all investigators in the neurosciences community," explained Claudia Chiriboga MD, MPH, co-principal investigator of Columbia-Weill Cornell NeuroNEXT site at NewYork-Presbyterian, associate professor of clinical neurology and pediatrics at Columbia University College of Physicians and Surgeon, and a pediatric neurologist at Morgan Stanley Children's Hospital of New-York-Presbyterian/Columbia. "We especially hope to involve young investigators who have a fantastic idea for a study but who may or may not know much about how to design or run a clinical trial. Using the expertise at our site and in the NeuroNEXT network, we can mentor these researchers and guide them through the grant proposal and trial design process."

Weill Cornell's contribution to the site will be led by Claire Henchcliffe, MD, DPhil, associate professor of neurology and neuroscience and the Daisy and Paul Soros Clinical Scholar in Neurology at Weill Cornell Medical College, and a neurologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

"NeuroNEXT is an innovative and exciting development," says Dr. Henchcliffe. "Not only does it leverage the superb clinical research infrastructure at these two academic medical centers, but it will help break down traditional research 'silos' and cultivate a culture of collaboration to more efficiently impact on future care of neurological disorders."

The CUMC-Weill Cornell NeuroNEXT site is supported by the NIH (1U10NS077267-01).