团结伙伴 - 新型和改编用于埃博拉病毒治疗的平台自适应随机试验 - 核心试验方案
平台自适应随机临床试验：针对新型及再利用的埃博拉病毒治疗方案 核心试验方案 草稿_机密 - 不得分发 版本 4.0 2023年8月24日 目录表 1.........................................................................................................................................................422.....................................................................................................................................933..................................................................................................................................................................1243.13.23.33.43.5566.................................................................................................................................................2076.16.26.36.46.56.66.76.86.97.................................................................................................................................2588............................................................................................................................................2799..........................................................................................................................................30109.19.29.39.49.59.69.710...........................................................................................................................................................321111....................................................................................................................................................3412第2页，共37页。试验概述背景与理由设计本研究旨在…（以下内容被省略）12资格............................................................................................................................................................12随机化..........................................................................................................................................13干预措施.............................................................................................................................................13研究结果.........................................................................................................................................144 S统计数据分析S..............................................................................................................................................155 DATAM监控C委员会（DMC）....................................................................................................................19研究程序实际考虑因素............................................................................................................................20身份识别.............................................................................................................................................20同意.....................................................................................................................................................20基准信息.................................................................................................................................21随机分配治疗........................................................................................................21治疗分配方案的行政执行….....................................................................................................21评估日程表...........................................................................................................................22患者监测..............................................................................................................................23收集后续信息..............................................................................................................236.10 同意撤回..............................................................................................................................24数据和安全性监测质量管理行政详情赞助和协调.........................................................................................................................30资金.....................................................................................................................................................30赔偿..................................................................................................................................................30研究治疗供应.......................................................................................................................30试用期结束.................................................................................................................................................30出版物和报告...........................................................................................................................30子研究.................................................................................................................................................31参考文献版本历史附录 1：组织结构及职责.....................................................................................35附录2：组织详情.........................................................................................................................375.1早期停止以获得利益........................
