事实或登记处的生活
当前的谁采用了登记处代表特定的地理领域，旨在具有全面和权威，但他们还必须适应健康研究的现实及其协作性质。可以在不同的来源列出相同的研究。作为世卫组织国际标准acknowledge: ‘it is possible that the trial will need to be registered more than once in order to meet the ethical, legal or other requirements of each country.’
语言方面也不应该被忽视。一个number of registries need to engage participants in their own language and additional efforts are needed to curate information both in the local language and in English for ICTRP purposes (the Brazilian registry offers three languages). Even amongst English language-based registries, objectives may be different: focused on very structured content (ClinicalTrials.gov）或期望提供简单的英语摘要（ISRCTN)。
所有注册机构都有其独特的存在理由，即使它们都具有共同的价值观和共同标准。记录复制的问题是我们活动的众所周知的事实。
When faced with duplication, aggregating sites wonder at first whether they should consider creating a ‘best’ record summarising all duplicates. This means creating an additional curation level which is labour intensive, when in fact different layers of information will serve different purposes and readers will decide which record is more informative. To the question ‘should identified overlaps be eradicated or displayed better, I would say the latter’.
对于“应确定的重叠应该可以消除或显示更好的问题，我会说后者”。
突出重复
一个cknowledging that duplication happens does not mean that registries do not have policies in place to track the nature and extent of overlaps.
一个s per International Standards ‘如果对一个以上的注册表进行了审判，则所有已知的试验标识符应作为二级标识符提交给每个注册表。其中包括其他注册机构分配的试用注册号。’
一个ll registries encourage researchers to check whether their study is already registered (for example一个ustralia New Zealand registry ‘how to register’ guidance)。然后各自的编辑团队开展全国矿工工会ber of cross checks on condition, country, funder, sponsor, name of investigator, number of participants involved etc., in order to establish whether a new submission could be a duplicate.
他们最终向申请人提出了任何发现。这可能会导致澄清记录的标题或某些方面，以消除其他先前存在的记录的歧义。后续研究和/或嵌套研究有时会提出一个问题，即它们是否保证自己的审判ID。ISRCTN拥有general rulesand also adopts a case by case approach. Decisions are made clear in fields such as Title and Editorial Notes.
Such checks do not mean that mistakes have never taken place. The evolution of theWHO ICTRP Minimum Data Set多年来，需要许多要素来描述一项研究。内部重复项的数量仍然很少，例如，在存在的10年以上，超过14,600条记录，ISRCTN注册表仅撤回了40个记录。
The WHO ICTRP uses the alphanumeric trial IDs as钩子在注册表之间。在特定领域，注册机构在记录其他注册表的记录这些“钩子”时（对于那些重叠可能性更大的注册机构，例如ClinicalTrial.gov或The TheEuropean registry EU-CTR）或辅助IDS字段。该辅助ID字段还将包含对数据提供商有意义的信息，即使不是公认的试验ID，因此注册管理人员必须平衡当地需求和国际需求。
由于其调节性汇率，EU-CTR目前的运行方式有所不同。其基础数据库图was initially designed to receive trial details from all EU member states. Duplication has been in existence right from the start but regularly已发表的统计数据distinguish between number of records and number of trials. There are likely to be changes in the way the information is presented when theRegulation EU 536/2014becomes effective in a few months.
Looking for, identifying and flagging hidden duplicates (i.e. records that will not quote trial IDs from other trial registries) seems like a never ending task. In good faith, registry 1 will have checked that a trial is not listed in likely candidate for overlap registry 2 but studies evolve and new countries can be added without the initial registry being notified immediately.
不要问注册表可以为您做什么……
Identifying overlaps between data sources could be seen as the role of aggregators. However the article (LINK) makes it very clear that it is quite labour intensive. The谁ICTRP通用试用号（UTN）曾经被视为可能的解决方案，但是从来没有清楚地是如何将一个数字未附加到明确描述试验且未公开责任的数据集上，实际上可以解决该问题。
WHO ICTRP网站等门户网站通常没有足够的资源来浏览数百个记录，并且必须将其货币限制为提供更全面的“单停机商店”进行试验。ICTRP专注于鼓励最佳实践，还计划添加新的数据元素。正在进行有关有关的讨论结果报告，由于大多数注册表确实记录了试验引起的出版物，因此门户网站获得更有信息的数据源是有意义的。
WHO ICTRP is focusing on standards for results.
其他利益相关者有角色。很可能会要求药品赞助商向WHO ICTRP提出一个单一的意见，但他们也可能不得不继续遵守当地法规。
一个ll registries expect records to be updated at regular intervals and will always welcome corrections. ISRCTN strongly encourages readers as well as systematic reviewers tocontact usshould they spot records that could reference other trial IDs in order to make the WHO ICTRP even more efficient in presenting related records.
可以在注册表中始终更新试验。
Registries are often asked ‘how many unique trials are taking place in country x for condition y’. To provide a bigger picture, they can only direct to other registries and/or aggregators and stress caveats. One major caveat is that, as rightly highlighted bythe article，始终低估了重叠。
一个‘proliferation’ of new registries will not necessarily make the identification of duplication worse. Recently accredited registries are very likely to be even more aware of the issue and to plan accordingly. By meeting local needs, they might also focus on studies beyond international drug trials and therefore not registered anywhere else, and so help the WHO ICTRP provide a greater coverage of clinical trials worldwide.
Comments