AllTrials组织声明:所有临床试验数据皆要公开

2013-03-22 MedSci MedSci原创

It’s time all clinical trial results are reported. Patients, researchers, pharmacists, doctors and regulators everywhere will benefit from publication of clinical trial results. Wherever you are in th

AllTrials logo for website

It’s time all clinical trial results are reported. Patients, researchers, pharmacists, doctors and regulators everywhere will benefit from publication of clinical trial results. Wherever you are in the world please sign the petition:

这是临床数据公开的时代。全世界的患者、研究员、药剂师、医生和监管部门都能从公开的数据中获益。无论你身在世界何处,我们恳求你能签下这份请愿书:

Thousands of clinical trials have not reported their results; some have not even been registered.

成千上万项临床试验结果销声匿迹;诸多试验未经注册。

Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

这些试验的所做和所得,将被永远掩埋。或许正是这些信息,误导了医生的临床抉择,让患者错失良药,研究者重复劳动。

All trials past and present should be registered, and the full methods and the results reported.

无论是过去还是现在,所有试验都应注册;所有方法和结果都应公开。

We call on governments, regulators and research bodies to implement measures to achieve this.

在此,我们呼吁:请政府、监管部门和研究机构,悉心致力,改革其司。

关于AllTrials

All Trials” 是一项由英国医学杂志BMJ,Bad Pharma一书的作者Ben Goldacre,科普组织Sense About Science,James Lind,以及牛津大学循证医学中心共同发起的活动。全球已经有超过170家组织,逾41,680人签名支持。

临床数据的重要性不言而喻。虽然,我们理解相关方对患者隐私的顾虑,但我们也相信,这绝对不会是“All Trials campaign”的障碍。来自NHS 2010年的调查显示,药企赞助的试验仅40%公布了临床结果;而非政府或商业参与的试验结果的公布率至少可以达到 55%。同时,药企赞助试验的阳性结果可达85.4%,远远超过非赞助试验的71.9%。我们猜不透这之间悬殊差异的原因。但无论是选择性发表,数据粉饰,抑或刻意隐瞒,这里有可能存在一些难以知晓的事情。但是对于患者而言,没有任何事情比患者的权益更重要,作为临床医生,研究参与者,甚至患者在临床试验结束后,有权知道临床试验中每一个细节。

早在上世纪90年代,CONSORT等组织就积极推动数据的透明化,公开化工作,要求所有临床试验都应该注册公开,在国际上形成ClinicalTrial等推动下,目前大型临床均进行事先注册。国内也成立临床试验注册中心,推动中国临床研究规范。MedSci认为,不仅是研究方案公开,也要求研究的数据进行公开,分享,以便更多的研究工作者能从这些数据中挖掘出深层次的临床价值,给医学做出贡献。

在国际上,尤其是北欧,已形成national-based大型登记数据库,为北欧人群的健康和生活品质带来重要的帮助和指引。这些大型登记数据库的公开分享,是对人类健康的巨大贡献。同样,临床试验的数据公开,也是极其重要和必要的事情。

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  2. [GetPortalCommentsPageByObjectIdResponse(id=2055218, encodeId=8dd3205521846, content=<a href='/topic/show?id=6f9391e7414' target=_blank style='color:#2F92EE;'>#试验数据#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91774, encryptionId=6f9391e7414, topicName=试验数据)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Thu Sep 26 01:36:00 CST 2013, time=2013-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056937, encodeId=6e53205693ee9, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Sat Dec 28 15:36:00 CST 2013, time=2013-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5857, encodeId=5def585efe, content=回复楼上的,我看到medsci在支持名单之列。不管多难,迟早一天都需要公开这些数据的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=life, createdTime=Tue Jul 02 22:26:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5856, encodeId=77b35856c8, content=去年写毕业论文的时候,研究医学期刊统计方法误用问题时,曾提出需要临床研究提供原始试验数据,特别是在中国。可惜人微言轻。现在终于有人意识到了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=赵龙刚, createdTime=Tue Jul 02 17:57:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5534, encodeId=00ad553441, content=非常好, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=good, createdTime=Mon Mar 25 15:11:00 CST 2013, time=2013-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328841, encodeId=1605132884139, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631313, encodeId=2e2a163131339, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=)]
    2013-12-28 zhzhxiang
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    2013-07-02 life

    回复楼上的,我看到medsci在支持名单之列。不管多难,迟早一天都需要公开这些数据的。

    0

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    2013-07-02 赵龙刚

    去年写毕业论文的时候,研究医学期刊统计方法误用问题时,曾提出需要临床研究提供原始试验数据,特别是在中国。可惜人微言轻。现在终于有人意识到了。

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2055218, encodeId=8dd3205521846, content=<a href='/topic/show?id=6f9391e7414' target=_blank style='color:#2F92EE;'>#试验数据#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91774, encryptionId=6f9391e7414, topicName=试验数据)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Thu Sep 26 01:36:00 CST 2013, time=2013-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056937, encodeId=6e53205693ee9, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Sat Dec 28 15:36:00 CST 2013, time=2013-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5857, encodeId=5def585efe, content=回复楼上的,我看到medsci在支持名单之列。不管多难,迟早一天都需要公开这些数据的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=life, createdTime=Tue Jul 02 22:26:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5856, encodeId=77b35856c8, content=去年写毕业论文的时候,研究医学期刊统计方法误用问题时,曾提出需要临床研究提供原始试验数据,特别是在中国。可惜人微言轻。现在终于有人意识到了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=赵龙刚, createdTime=Tue Jul 02 17:57:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5534, encodeId=00ad553441, content=非常好, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=good, createdTime=Mon Mar 25 15:11:00 CST 2013, time=2013-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328841, encodeId=1605132884139, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631313, encodeId=2e2a163131339, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=)]
    2013-03-25 good

    非常好

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2055218, encodeId=8dd3205521846, content=<a href='/topic/show?id=6f9391e7414' target=_blank style='color:#2F92EE;'>#试验数据#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91774, encryptionId=6f9391e7414, topicName=试验数据)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Thu Sep 26 01:36:00 CST 2013, time=2013-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056937, encodeId=6e53205693ee9, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Sat Dec 28 15:36:00 CST 2013, time=2013-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5857, encodeId=5def585efe, content=回复楼上的,我看到medsci在支持名单之列。不管多难,迟早一天都需要公开这些数据的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=life, createdTime=Tue Jul 02 22:26:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5856, encodeId=77b35856c8, content=去年写毕业论文的时候,研究医学期刊统计方法误用问题时,曾提出需要临床研究提供原始试验数据,特别是在中国。可惜人微言轻。现在终于有人意识到了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=赵龙刚, createdTime=Tue Jul 02 17:57:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5534, encodeId=00ad553441, content=非常好, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=good, createdTime=Mon Mar 25 15:11:00 CST 2013, time=2013-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328841, encodeId=1605132884139, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631313, encodeId=2e2a163131339, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=)]
    2013-03-24 膀胱癌
  7. [GetPortalCommentsPageByObjectIdResponse(id=2055218, encodeId=8dd3205521846, content=<a href='/topic/show?id=6f9391e7414' target=_blank style='color:#2F92EE;'>#试验数据#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91774, encryptionId=6f9391e7414, topicName=试验数据)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/656F31B644588474D1C46903A7F84373/100, createdBy=4e842500199, createdName=ms24272190615788285182, createdTime=Thu Sep 26 01:36:00 CST 2013, time=2013-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056937, encodeId=6e53205693ee9, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Sat Dec 28 15:36:00 CST 2013, time=2013-12-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5857, encodeId=5def585efe, content=回复楼上的,我看到medsci在支持名单之列。不管多难,迟早一天都需要公开这些数据的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=life, createdTime=Tue Jul 02 22:26:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5856, encodeId=77b35856c8, content=去年写毕业论文的时候,研究医学期刊统计方法误用问题时,曾提出需要临床研究提供原始试验数据,特别是在中国。可惜人微言轻。现在终于有人意识到了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=赵龙刚, createdTime=Tue Jul 02 17:57:00 CST 2013, time=2013-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=5534, encodeId=00ad553441, content=非常好, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=good, createdTime=Mon Mar 25 15:11:00 CST 2013, time=2013-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1328841, encodeId=1605132884139, content=<a href='/topic/show?id=bb96232801' target=_blank style='color:#2F92EE;'>#ALL#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2328, encryptionId=bb96232801, topicName=ALL)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/1103841572/C2EFD5CFB07FE291138AD4FD0C98E3DE/100, createdBy=e3d52500031, createdName=膀胱癌, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631313, encodeId=2e2a163131339, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Sun Mar 24 02:36:00 CST 2013, time=2013-03-24, status=1, ipAttribution=)]
    2013-03-24 feifers