晚期肝细胞癌临床试验终点技术指导原则(征求意见稿)

2020-06-28 国家药品监督管理局药品审评中心(CDE) CDE

晚期肝细胞癌是抗肿瘤新药研发的热点领域,创新药物众多,涌现出了复杂的终点指标和研究设计,现有指导原则尚不能涵盖。为给业界人员在临床研发路径和临床研究设计方面提供参考,提高临床研发效率,我中心起草了《晚

中文标题:

晚期肝细胞癌临床试验终点技术指导原则(征求意见稿)

发布日期:

2020-06-28

简要介绍:

晚期肝细胞癌是抗肿瘤新药研发的热点领域,创新药物众多,涌现出了复杂的终点指标和研究设计,现有指导原则尚不能涵盖。为给业界人员在临床研发路径和临床研究设计方面提供参考,提高临床研发效率,我中心起草了《晚期肝细胞癌临床试验终点技术指导原则(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一个月。
       您的反馈意见请发到以下联系人的邮箱:
       联系人:郝瑞敏,仝昕
       联系方式:haorm@cde.org.cn,tongx@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6月24日

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《晚期肝细胞癌临床试验终点技术指导原则(征求意见稿)》.docx
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