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ICH E9临床试验的统计学指导原则解析

2012-05-28 MedSci MedSci原创

ICHE9临床试验统计
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ICH E9 Statistical principles for clinical trials （临床试验的统计学指导原则）可谓生物统计师的bible，目的在于协调欧洲、日本和美国在进行药品上市申请的临床试验时所应用的统计学方法的指导原则。虽说中国是协调三方之外的国家，SFDA还为此另外制定了自己的《化学药物和生物制品临床试验的生物统计学技术指导原则》，但其内容基本还是照抄翻译了ICH E9的

ICH E9 Statistical principles for clinical trials （临床试验的统计学指导原则）可谓生物统计师的bible，目的在于协调欧洲、日本和美国在进行药品上市申请的临床试验时所应用的统计学方法的指导原则。虽说中国是协调三方之外的国家，SFDA还为此另外制定了自己的《化学药物和生物制品临床试验的生物统计学技术指导原则》，但其内容基本还是照抄翻译了ICH E9的内容。首先，我们先看一下ICH E9的内容概况：1． 引言2． 整个临床试验的基本考虑3． 试验设计中的基本考虑4． 试验进行中的基本考虑5． 数据分析6． 安全性与耐受性评价7． 研究报告临床研发计划中的统计思维众所周知，药物临床研究的主要目标就是以最小的成本和最快的时间，科学地评估有希望进入市场的药物的风险－效益。万事计划为先，为了保证药物研发的成功，制定一个临床研发计划（clinical development plan）是十分必要的。那什么是临床研发计划包括哪些内容呢？通常地，临床研发计划包括研发依据、试验的一些基本情况、时间表、预算以及所需的人力物力财力资源等。在大多数公司，在开展一

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    2023-10-18 微火 来自江苏省

    留个言呀

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2163546, encodeId=abff216354635, content=留个言呀 , beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLFANeJXEIWlIPVMaWJhw9icZkD02dVtIq4Lic983583DKR32k3E5CgFyZLnTj9GQRz0F9LRtiaBOIeQ/132, createdBy=cbf25156103, createdName=微火, createdTime=Wed Oct 18 13:35:16 CST 2023, time=2023-10-18, status=1, ipAttribution=江苏省), GetPortalCommentsPageByObjectIdResponse(id=4885, encodeId=1aae4885b6, content=小胖的东西，一定得顶呀！, beContent=null, objectType=article, channel=null, level=null, likeNumber=138, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=480070911, createdName=eliving, createdTime=Fri Nov 02 09:50:00 CST 2012, time=2012-11-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1672672, encodeId=c3ea16e267294, content=<a href='/topic/show?id=b79b910345c' target=_blank style='color:#2F92EE;'>#解析#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91034, encryptionId=b79b910345c, topicName=解析)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f42d26916490, createdName=hongbochen, createdTime=Tue Feb 05 22:26:00 CST 2013, time=2013-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1316331, encodeId=427b1316331ad, content=<a href='/topic/show?id=f3789349c3' target=_blank style='color:#2F92EE;'>#ICH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9349, encryptionId=f3789349c3, topicName=ICH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c192448, createdName=diushouji, createdTime=Wed May 30 01:26:00 CST 2012, time=2012-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1442266, encodeId=3a401442266dd, content=<a href='/topic/show?id=4989e8938c9' target=_blank style='color:#2F92EE;'>#统计学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78938, encryptionId=4989e8938c9, topicName=统计学)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=df8a4916199, createdName=siiner, createdTime=Wed May 30 01:26:00 CST 2012, time=2012-05-30, status=1, ipAttribution=)]
    2012-11-02 eliving

    小胖的东西，一定得顶呀！

    0

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    2013-02-05 hongbochen

    #解析#

    0

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    2012-05-30 diushouji

    #ICH#

    0

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    2012-05-30 siiner

    #统计学#

    0

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