神经科学卓越临床试验网络NeuroNEXT:概念实现(P04.245)

文摘

摘要目的: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:在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:协议执行的所有CSS依赖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。这项研究是提交给CIRB完全检查7月18日^th在8月21日,获得完整的CIRB批准^圣,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。

结论:NeuroNEXT网络已成功地建立了基础设施,将极大地提高临床试验的效率和质量。

支持:研究所。

披露:卡尼博士没有披露。Ecklund博士没有披露。辛普森博士没有披露。博世博士没有披露。博士甜没有披露。杰克逊博士没有披露。马奥尼博士没有披露。麦考特博士没有披露。托内尔博士没有披露。提图斯博士没有披露。 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.