Columbia, Weill Cornell join national effort to spur clinical trials in neurosciences

Friday, March 16, 2012 11:49 AM

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 (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 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 grant NINDS, a division of the NIH.

NeuroNEXT will focus on phase II exploratory clinical trials so that researchers can efficiently test new treatments before embarking on large and costly phase III 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. NeuroNEXT will also employ the use of a common institutional review board, which could 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. "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."

"NeuroNEXT is an innovative and exciting development," added Claire Henchcliffe, MD DPhil, a neurologist at the NewYork-Presbyterian Hosital.Weill Cornell Medical Center. "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 Columbia-Weill Cornell NeuroNEXT site is supported by the NIH.

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