TY -的T1神经科学卓越临床试验网络NeuroNEXT:概念实现(P04.245) JF -神经学乔-神经病学SP - P04.245 LP - P04.245六世- 80 - 7补充AU -玛丽安科尔尼非盟-南方Ecklund AU -伊丽莎首页白·辛普森AU -迈克尔·博世AU -布莱恩甜盟-凯瑟琳·杰克逊盟-凯蒂Mahoney AU -米歇尔•麦考特盟-布伦达托内尔盟-萨拉提多盟-娜塔莎Soodoo盟Janice O ' brien盟-凯瑟琳戴手套AU -米歇尔·科斯蒂根AU -妮拉Logsden-Sackett盟特列维发怒AU -杰里米Shefner盟劳里古特曼AU -威廉克拉克AU -詹姆斯被非盟-杰弗里长非盟-凯瑟琳·查洛盟夫人艾米奈住在港湾的居民盟成员Walter Koroshetz -麦克内尔黎明盟盟-佩特拉Kaufmann盟-绩效Cudkowicz盟-克里斯托弗·科菲Y1 - 2013/02/12 UR - //www.ez-admanager.com/content/80/7_Supplement/P04.245.abstract N2 -目的:NeuroNEXT旨在扩大研究所的能力测试有前途的新疗法,临床试验,提高效率,快速响应新的机会出现测试有前途的治疗神经障碍患者。背景:2011年10月,研究所授予临床协调中心(CCC)格兰特MGH数据协调中心(DCC)授予爱荷华大学,和临床研究网站(CSS)授予25学术机构。三个新颖的措施,以提高网络中进行临床试验的效率提出了:利用中央IRB (CIRB)的记录,建立主临床试验协议(MCTA)与所有CSS,和可用性经验丰富的试验设计人员协助研究组长。设计/方法:CCC和DCC发达50为网络操作标准操作程序。CIRB举行电话会议,一个在人会见IRB的领导人CSS。在2011年10月,NeuroNEXT执行委员会(NEC)成立并开始复习建议。研究所的目标和使命,所遇到的那些困难和被批准的NEC,接着一个协议工作组(倍增)设计最强的协议和授权程序的目的。结果:所有CSS执行协议的依赖与CIRB(平均25天,范围1 - 43天),和MCTA(意思是50天,范围4 - 168天)。2012年4月宣布第一资助研究。这项研究是提交详尽的回顾CIRB 7月18日,获得完整的CIRB批准在8月21日,2012年。第一年,60提议被提交到研究所,32报NEC和18形成倍增。四拨款申请被提交给审查研究所;与一个额外的8预计在2012年12月。CONCLUSIONS: The NeuroNEXT Network has successfully established infrastructure that will greatly increase the efficiency and quality of clinical trials.Supported by: NINDS.Disclosure: Dr. Kearney has nothing to disclose. Dr. Ecklund has nothing to disclose. Dr. Simpson has nothing to disclose. Dr. Bosch has nothing to disclose. Dr. Sweet has nothing to disclose. Dr. Jackson has nothing to disclose. Dr. Mahoney has nothing to disclose. Dr. McCourt has nothing to disclose. Dr. Thornell has nothing to disclose. Dr. Titus has nothing to disclose. Dr. Soodoo has nothing to disclose. Dr. O'Brien has nothing to disclose. Dr. Gloer has nothing to disclose. Dr. Costigan has nothing to disclose. Dr. Logsden-Sackett has nothing to disclose. Dr. Huff has nothing to disclose. Dr. Shefner has received personal compensation for activities with Biogen-Idec and Glaxo SmithKline as a member of the advisory boards, and from Cytokinetics, Inc as a consultant. Dr. Shefner has received personal compensation in an editorial capacity for the Neuromuscular Section Editor of UpToDate. Dr. Shefner has received research funding from NIH, the ALS Association, the ALS Therapy Alliance, MDA, Glaxo Smith Kline, Isis Pharmaceuticals, Biogen-Idec, Cytokinetics, Inc., and Sanofi Pharmaceuticals. Dr. Gutmann has received research support from Allergan, Inc. and Cytokinetics. Dr. Clarke has nothing to disclose. Dr. Torner has received personal compensation for activities with BHR Pharmaceuticals and Actelion Pharmaceuticals as a consultant. Dr. Long has nothing to disclose. Dr. Chaloner has nothing to disclose. Dr. Bayman has received compensation for serving on the editorial board of Neurosurgery. Dr. McNeil has nothing to disclose. Dr. Koroshetz has nothing to disclose. Dr. Kaufmann has nothing to disclose. Dr. Cudkowicz has received personal compensation for activities with GlaxoSmithKline, Inc. and Teva Neuroscience. Dr. Cudkowicz has received research support from Biogen Idec and Neuraltis. Dr. Coffey has received personal compensation for activities with ZZ Biotech, LLC as a consultant.Wednesday, March 20 2013, 7:30 am-12:00 pm ER -