TY - T1的血管内缺血性中风临床试验设计干预JF -神经病学,23(3)乔-神经病学SP - S221 LP -做- 10.1212 / WNL。首页0 b013e31826992cf六世- 79 - 13补充1 AU -奥萨马o . Zaidat盟David s . Liebeskind AU -兰德尔·c·Edgell盟凯瑟琳·m·Amlie-Lefond AU - Junaid s氧化钾盟安德烈诉Alexandrov Y1 - 2012/09/25 UR - //www.ez-admanager.com/content/79/13_Supplement_1/S221.abstract首页 N2 -背景:随机、双盲、安慰剂对照试验对临床实践产生重大影响。的终极目标治疗急性缺血性中风的临床试验(AIS)是比较2干预措施。挑战可能包括介入治疗规范化、入学率、病人选择,偏见,数据和安全监控、报告和财务和后勤支持。方法:选择随机单组未来AIS和试验设计。综述了临床试验元素及其挑战。创新设计和提出建议来克服的一些特定的挑战和局限性进行了讨论。结果:AIS治疗试验具体挑战相关的伦理问题,入学率,结果措施,有限的时间治疗,疗效,安全性,和有限的或变量操作经验与复杂的技术精致的器官。提出建议改善试验设计包括以下:整合引入阶段;细心耐心,结果测量选择; historical, concurrent, or hybrid controls; open data access; and a Bayesian approach. An open data paradigm may facilitate creation of computerized prediction models for future trials (minimizing cost by decreasing sample size or providing futility analyses and directing resources to other trials). Collaborative, consortium, and network infrastructures may allow more effective and efficient study completion. Self-learning, self-correcting trials with intrinsic flexibility to adapt may help future clinical trial design in AIS. Conclusion: The randomized clinical trial design in AIS endovascular therapy is challenging. Lead-in phases, careful patient selection, use of innovative outcome measures, control groups, and newer clinical trial design may enhance conduct of future trials, their validity, and their results. AIS=acute ischemic stroke; BI=Barthel Index; CER=comparative effectiveness research; CRF=case report form; ET=endovascular therapy; FDA=US Food and Drug Administration; IC=informed consent; IMS=Interventional Management of Stroke; IRB=institutional review board; mRS=modified Rankin Scale score; NIHSS=NIH Stroke Scale; RCT=randomized controlled trial; TICI=thrombolysis in cerebral ischemia; TIMI=thrombolysis in myocardial ischemia; tPA=tissue plasminogen activator ER -