关于公开征求《药物临床试验适应性设计指导原则》意见的通知

2020-05-15 CDE CDE

为了促进药物临床试验各相关方对临床试验适应性设计的理解与合理应用,经广泛调研和讨论,我中心组织起草了《药物临床试验适应性设计指导原则(征求意见稿)》。

 为了促进药物临床试验各相关方对临床试验适应性设计的理解与合理应用,经广泛调研和讨论,我中心组织起草了《药物临床试验适应性设计指导原则(征求意见稿)》。
       我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议,并及时反馈给我们,以便后续完善。征求意见时限为自发布之日起3个月。
       您的反馈意见请发到以下联系人的邮箱:
       联系人:潘建红、缪欣怡
       联系方式:panjh@cde.org.cnmiaoxy@cde.org.cn
       感谢您的参与和大力支持。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2020年5月13日

附件 1 : 药物临床试验适应性设计指导原则(征求意见稿).docx
附件 2 : Guideline on Adaptive Designs for Clinical Trials (Draft for public review).docx
附件 3 : 《药物临床试验适应性设计指导原则(征求意见稿)》起草说明.doc

 

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