关于公开征求《抗急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则(征求意见稿)》意见的通知

2020-05-15 CDE CDE

在急性淋巴细胞白血病(Acute lymphoblastic leukemia,ALL)诊治过程中,微小残留病(Minimal residual disease,MRD)(或称可检测残留病 [Meas

在急性淋巴细胞白血病(Acute lymphoblastic leukemia,ALL)诊治过程中,微小残留病(Minimal residual disease,MRD)(或称可检测残留病 [Measurable residual disease])状态可以反映治疗后的反应程度和疾病负荷,是决定患者的危险分层、预后判断、后续治疗选择的关键因素之一,因此成为临床治疗中进行疾病监测的良好生物标记物。然而,如何在新药研发临床试验中合理应用MRD,目前国内尚无相关技术要求或行业标准可循。为进一步规范行业操作,明确技术标准,我中心起草了《抗急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则》,经中心内部讨论,并征求部分专家意见,现形成征求意见稿。
       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:邹丽敏,齐玥丽
       联系方式:zoulm@cde.org.cn,qiyl@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8日

附件 1 : 《抗急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则(征求意见稿)》.docx
附件 2 : 《抗ALL药物临床试验中检测MRD的技术指导原则(征求意见稿)》起草说明.docx
附件 3 : 抗急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则(征求意见稿)意见反馈表.docx

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