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PRO专题：新药临床试验要尊重患者感受——Our Health,Our Care,Our Say

2017-03-14 吕 静/张岩波 BioMed数据坊

PRO临床试验患者
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近年来，在临床研究中，通过测评患者对自身疾病症状及其对日常生活所造成的影响所持的态度，来决定治疗方案以及作为评价疗效的工具已经越来越普遍。临床研究领域关键人物也开始认识到了患者报告临床结局（patient reported outcome，PRO）测评日益增长的价值。2006年2月美国FDA（Food and Drug Administration）发布了关于PRO应用于新药研制和疗效评价的指南草

近年来，在临床研究中，通过测评患者对自身疾病症状及其对日常生活所造成的影响所持的态度，来决定治疗方案以及作为评价疗效的工具已经越来越普遍。临床研究领域关键人物也开始认识到了患者报告临床结局（patient reported outcome，PRO）测评日益增长的价值。2006年2月美国FDA（Food and Drug Administration）发布了关于PRO应用于新药研制和疗效评价的指南草案，意味着PRO正成为评价疗效和药物安全性的重要组成部分。而患者也终于能够参与到治疗方案的制定中来，甚至有可能参与到药物安全性和药价的制定过程中。如在高度竞争的市场体制下，制药业开始拥有更多的知识性客户，制药业市场面临巨大的成本压力和产品差异化趋势。为了确保产品的成功，制药公司必须提出超越传统的安全性和临床疗效性的价值主张。其中一条途径就是收集从患者的角度出发对疗效进行评价的证据。而这些证据一般都是通过测量评估患者对产品的意见获得。那到底什么是PRO，PRO为何受到如此重视，又有哪些价值？所谓的PRO是指直接来自于患者对自身健康状况、功能状态以及治疗感受的报告，其中不包括医护人员及其他任何人员

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    2017-09-21 108807375_62823137

    #专题#

    0

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    2017-04-05 lemon985

    如果知道自己是安慰剂组会气死

    0

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    2017-10-09 shizhenshan

    #ALT#

    0

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    2017-03-21 虈亣靌

    学习一下很不错

    0

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    2017-03-20 laoli

    非常有价值，谢谢！

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1707415, encodeId=001d1e07415a2, content=<a href='/topic/show?id=25df20e54dc' target=_blank style='color:#2F92EE;'>#专题#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20754, encryptionId=25df20e54dc, topicName=专题)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1f4231418733, createdName=108807375_62823137, createdTime=Thu Sep 21 13:12:00 CST 2017, time=2017-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=185213, encodeId=f8c71852136d, content=如果知道自己是安慰剂组会气死, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca432042642, createdName=lemon985, createdTime=Wed Apr 05 00:12:09 CST 2017, time=2017-04-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861079, encodeId=f4ac18610e9c6, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Mon Oct 09 16:12:00 CST 2017, time=2017-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=181693, encodeId=01f1181693a1, content=学习一下很不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Tue Mar 21 13:44:05 CST 2017, time=2017-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=181480, encodeId=ed41181480cc, content=非常有价值，谢谢！, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLC1BMzZWdMSPQWuib6BtQGicK8ygGBM6YakpfkRc67soFSuKbZr86enL1KggQZEZbgWSeicJibafmYfQ3AibicIHMwwicmDShfRFvvI38/0, createdBy=272a110164, createdName=laoli, createdTime=Mon Mar 20 20:08:44 CST 2017, time=2017-03-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1601833, encodeId=0f5d1601833dc, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Thu Mar 16 02:12:00 CST 2017, time=2017-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621595, encodeId=3d7616215951b, content=<a href='/topic/show?id=5f1386329e' target=_blank style='color:#2F92EE;'>#Health#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8632, encryptionId=5f1386329e, topicName=Health)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Thu Mar 16 02:12:00 CST 2017, time=2017-03-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=179837, encodeId=5f7e1e98371c, content=内容精彩，不容错过, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuOWcPEsEP4FrvDcicue5V6rMkmXmY73KjYP59vQrEdjU89iaN4ZkOhsItlHkmGTjhV3b5S3zOQA4E0/0, createdBy=cc261682151, createdName=卡圣, createdTime=Tue Mar 14 13:33:08 CST 2017, time=2017-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=179831, encodeId=2ce91e983153, content=medsci真的很好，涉及方方面面的知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaEJicFGXtYqfjGiaibNdjOiaRgkexnXiciaDeXaLiaKicovcicDugdYwRPSnQj3FlfXBwVLB5ANB9PGFyB0kraQ/0, createdBy=35b01663265, createdName=1ddf3e1dm99(暂无匿称), createdTime=Tue Mar 14 13:25:28 CST 2017, time=2017-03-14, status=1, ipAttribution=)]
    2017-03-16 sunylz

    #PRO#

    0

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    2017-03-16 yyanpro@28cn.c

    #Health#

    0

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    2017-03-14 卡圣

    内容精彩，不容错过

    0

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    2017-03-14 1ddf3e1dm99(暂无匿称)

    medsci真的很好，涉及方方面面的知识

    0