Previously unidentified duplicate registrations of clinical trials: an exploratory analysis of registry data worldwide
Previously unidentified duplicate registrations of clinical trials: an exploratory analysis of registry data worldwide
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DOI：
10.1186/s13643-016-0283-8
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发表时间：
2016-01-01
影响因子：
3.7
通讯作者：
Zarin, Deborah A.
中科院分区：
文献类型：
--
作者：
van Valkenhoef, Gert;Loane, Russell F.;Zarin, Deborah A.
背景资料：建立试验登记处是为了通过创建一个全面和明确的已启动临床试验记录来消除发表偏倚。然而，登记中心和登记政策的激增意味着单个试验可能被登记多次（即，“重复”）。由于不明重复威胁到我们的能力，以确定明确的试验，我们调查到什么程度重复已确定跨registrationsglobal.Methods：我们检索所有记录从世界卫生组织（WHO）国际临床试验注册平台（ICTRP）的搜索门户网站，并列出了所有记录确定为重复的ICTRP。为了研究如何区分重复与非重复，我们应用基于文本的相似性评分的ICTRP确定的重复和任意对试验的各种注册字段。然后，我们使用最佳相似性度量来识别最相似的记录对，并手动评估未被ICTRP识别为重复的对的随机样本，以估计先前未识别（或“隐藏”）的重复数量。结果：2015年4月，从ICTRP门户网站检索到28.5万条独特记录，或在考虑已知重复后的27.1万项独特试验。我们发现标题字段最能区分重复和非重复。在总共410亿次成对比较中，我们确定了474，000对具有最高相似性分数（> 0.5）的标题。在手动评估434对随机样本后，我们估计目前所有重复注册中有45%未被检测到，仍有待识别和确认为重复。因此，该数据集中代表的独特试验的实际数量估计约为258，000（少5%）。结论：ICTRP门户网站目前无法明确识别各注册中心的试验。需要进一步研究，以确定和核实目前未被发现的重复。申办者、注册机构和ICTRP应考虑采取措施，确保重复注册易于识别。
Background: Trial registries were established to combat publication bias by creating a comprehensive and unambiguous record of initiated clinical trials. However, the proliferation of registries and registration policies means that a single trial may be registered multiple times (i.e., "duplicates"). Because unidentified duplicates threaten our ability to identify trials unambiguously, we investigate to what degree duplicates have been identified across registries globally.Methods: We retrieved all records from the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal and made a list of all records identified as duplicates by the ICTRP. To investigate how to discriminate duplicates from non-duplicates, we applied text-based similarity scoring to various registration fields of both ICTRP-identified duplicates and arbitrary pairs of trials. We then used the best similarity measure to identify the most similar pairs of records and manually assessed a random sample of pairs not identified as duplicates by the ICTRP to estimate the number of previously unidentified (or "hidden") duplicates.Results: Two hundred eighty-five thousand unique records, or 271 thousand unique trials after accounting for known duplicates, were retrieved from the ICTRP portal in April 2015. We found that the title field best discriminated duplicates from non-duplicates. Out of 41 billion total pair-wise comparisons, we identified the 474,000 pairs of titles with the highest similarity scores (> 0.5). After manually assessing a random sample of 434 pairs, we estimated that 45 % of all duplicate registrations currently go undetected and remain to be identified and confirmed as duplicates. Thus, the actual number of unique trials represented in this dataset is estimated to be approximately 258,000 (5 % less).Conclusions: The ICTRP portal does not currently enable the unambiguous identification of trials across registries. Further research is needed to identify and verify the duplicates that currently go undetected. Sponsors, registries, and the ICTRP should consider actions to ensure duplicate registrations are easily identifiable.