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Newly established neuroscience clinical trials center could bringtreatments to patients faster by grehh hernjer





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Newly established neuroscience clinical trials center could bringtreatments to patients faster by
Article Posted: 03/24/2013
Article Views: 47
Articles Written: 1951
Word Count: 693
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Newly established neuroscience clinical trials center could bringtreatments to patients faster


 
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In a development that could pave the way for treatment for rareneurological diseases and clues to more common ones,physician-scientists at Albert Einstein College of Medicine ofYeshiva University and Montefiore Medical Center, the UniversityHospital for Einstein, have secured a grant to establish a clinicalsite for the Network for Excellence in Neuroscience Clinical Trials(NeuroNEXT). One of only 25 such federally-funded centers in thecountry, the Einstein-Montefiore site was created in partnershipwith Einstein affiliates Beth Israel Medical Center in Manhattanand the North Shore-Long Island Jewish Health System. The NeuroNEXTnetwork and its centers were established with grants from theNational Institute of Neurological Disorders and Stroke (NINDS),part of the National Institutes of Health. NeuroNEXT was created to facilitate Phase II clinical trials forrare neurological diseases, which face significant challengessecuring funding from industry, as well as with recruiting andretaining participants. (Phase II trials are conducted to assesshow well and at what frequency and dosage a drug delivers effectiveresults.) Should a promising drug be identified, enrolling enoughparticipants with these rare disorders requires identifying andenlisting multiple sites around the country each of which can onlycontribute a few patients.

Additionally, each has its own rigorousprocess in place to oversee such research. These hurdles often prove insurmountable. By establishing apre-existing network of sites and streamlining cumbersomelogistics, the NeuroNEXT network and their centers aim to changethat. "We'll basically be a S.W.A.T.

team," said Shlomo Shinnar,M.D., Ph.D., co-principal investigator on the grant. "Researchersand interested physicians with no research experience will be ableto tap into an existing infrastructure that can provide theresearch and regulatory expertise to participate in these clinicaltrials. Normally, when you build a multi-center study, it can takea year or two to get the trial going. We hope to get this down to afew months." Dr.

Shinnar is professor in the Saul R. KoreyDepartment of Neurology and of pediatrics at Einstein and anattending physician at Montefiore. Despite the difficulties in initiating these studies, significantadvances have been made in recent years in the understanding andtreatment of unusual neurological disorders. "While common diseases like Alzheimer's and Parkinson's have beenslow to give up their secrets, real progress has been made indiscovering the origins of and therapies for rare neurologicaldiseases," said Mark Mehler, M.D., professor and chair of the SaulR. Korey Department of Neurology at Einstein and chair of neurologyat Montefiore.

"While this initiative offers us an opportunity todramatically change the lives of patients with these rare diseases,the findings are also likely to provide insight into more commonneurological disorders, like migraine and stroke , which affect millions of people." Dr. Mehler also holds theAlpern Family Foundation Chair in Cerebral Palsy Research atEinstein. The Einstein-NeuroNEXT includes over 150 adult neurologists and 25pediatric neurologists who serve an unusually diverse populationbase of over 8 million. Einstein's clinical affiliates haveneurological expertise across all age groups children, adults andgeriatrics.

Each year, these affiliates assess over 35,000individual neurology patients, including more than 10,000 pediatricneurology patients. Each clinical site boasts special clinicalexpertise, including the Sleep-Wake Center and Rett Syndrome Centerat Montefiore, Beth Israel's Bachman-Strauss Dystonia Center ofExcellence and North Shore-LIJ's work with Huntington's Disease atthe Cushing Movement Disorders Institute. "In addition to the breadth and strength of our center's expertisein rare neurological disorders, the success of our application wasaided by the existence of the NIH-funded Einstein-MontefioreInstitute for Clinical and Translational Research and the newlyestablished Office of Clinical Trials," said Richard Lipton, M.D.,co-principal investigator on the grant. "Both centers wereestablished to promote and facilitate clinical research and trialsand together they represent Einstein and Montefiore's commitment,knowledge and skill in the area." Dr. Lipton is professor and vicechair of the Saul R.

Korey Department of Neurology, the Edwin S.Lowe Chair of Neurology, and professor of psychiatry and behavioralsciences at Einstein. He is also director of the MontefioreHeadache Center. NeuroNEXT centers are encouraged to submit their proposals forclinical trials to the network for evaluation. The inaugural studywill focus on spinal muscular atrophy and recruitment will begin this year.

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