Samanta Anwesha Dhal, Borah Rishima, Saberwal Gayatri
Institute of Bioinformatics and Applied Biotechnology, Bengaluru, India.
Front Med (Lausanne). 2024 Jul 5;11:1357930. doi: 10.3389/fmed.2024.1357930. eCollection 2024.
Clinical trial registries serve a key role in tracking the trial enterprise. We are interested in the record of trials sites in India. In this study, we focused on the European Union Clinical Trial Registry (EUCTR). This registry is complex because a given study may have records from multiple countries in the EU, and therefore a given study ID may be represented by multiple records. We wished to determine what steps are required to identify the studies that list sites in India that are registered with EUCTR.
We used two methodologies. Methodology A involved downloading the EUCTR database and querying it. Methodology B used the search function on the registry website.
Discrepant information, on whether or not a given study listed a site in India, was identified at three levels: (i) the methodology of examining the database; (ii) the multiple records of a given study ID; and (iii) the multiple fields within a given record. In each of these situations, there was no basis to resolve the discrepancy, one way or another.
This work contributes to methodologies for more accurate searches of trial registries. It also adds to the efforts of those seeking transparency in trial data.
临床试验注册在跟踪试验事业方面发挥着关键作用。我们对印度试验地点的记录感兴趣。在本研究中，我们重点关注欧盟临床试验注册库（EUCTR）。该注册库很复杂，因为一项特定研究可能在欧盟多个国家都有记录，因此一个特定的研究编号可能由多条记录表示。我们希望确定需要采取哪些步骤来识别在EUCTR注册的、列出印度试验地点的研究。
我们使用了两种方法。方法A包括下载EUCTR数据库并进行查询。方法B使用注册库网站上的搜索功能。
在三个层面发现了关于一项特定研究是否列出印度试验地点的不一致信息：（i）检查数据库的方法；（ii）一个特定研究编号的多条记录；以及（iii）一条特定记录中的多个字段。在上述每种情况下，都没有办法以任何一种方式解决这种不一致。
这项工作有助于采用更准确的方法搜索试验注册库。它也为那些寻求试验数据透明度的人所做的努力增添了内容。
