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抗肿瘤药联合治疗临床试验 技术指导原则 (征求意见稿)

2020-07-17 国家药品监督管理局药品审评中心(CDE) CDE

目前抗肿瘤药物联合开发十分活跃。合理的联合治疗可以为肿瘤患者带来更好的治疗选择,但是不恰当的联合开发将增加受试者的风险、降低临床研发效率,浪费时间、财力和医疗资源,反而阻碍了真正有效的联合治疗药物开发

中文标题:

抗肿瘤药联合治疗临床试验 技术指导原则 (征求意见稿)

发布日期:

2020-07-17

简要介绍:

目前抗肿瘤药物联合开发十分活跃。合理的联合治疗可以为肿瘤患者带来更好的治疗选择,但是不恰当的联合开发将增加受试者的风险、降低临床研发效率,浪费时间、财力和医疗资源,反而阻碍了真正有效的联合治疗药物开发。为此,建立科学合理的联合开发路径至关重要。
       为切实鼓励创新,引导开展科学有序的抗肿瘤药联合治疗临床试验,药品审评中心组织撰写了《抗肿瘤药联合治疗临床试验技术指导原则(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1个月。
       您的反馈意见请发到以下联系人的邮箱:
       联系人:周明,唐凌
       联系方式:zhoum@cde.org.cn,tangl@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7月17日

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《抗肿瘤药联合治疗临床试验技术指导原则(征求意见稿)》 (1).pdf
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#插入话题
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    2021-05-14 ms7000001395190706

    0

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    2020-08-04 ms5000002021119594

    加油!好

    0

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