{"title":"Identifying trials run in India that are registered in other clinical trial registries: a cross-sectional study","authors":"Rishima Borah, Anwesha Dhal Samanta, Jaishree Mendiratta, Manish Mishra, Gayatri Saberwal","doi":"10.1186/s12874-024-02336-w","DOIUrl":null,"url":null,"abstract":"Clinical trials play a crucial role in biomedical research, and it is important to register them in public registries to ensure transparency and prevent research waste. In this study, we wished to determine what steps need to be taken to identify every clinical trial run in India that has been registered in any of the (non-Indian) World Health Organization-recognised primary registries. Of the 16 registries, we studied all except that of the European Union, which will be studied separately. Two methodologies were employed for each registry, except for four that did not facilitate one or the other method. Methodology A involved downloading all the records in a registry and querying them. Methodology B involved conducting a search via the registry website. Only four registries provided consistent results with both methodologies. Seven registries had different results from the two methodologies. Of these, in four cases, in Methodology A one field indicated that the study ran in India, while another indicated otherwise. The above-mentioned ambiguities should be addressed by the concerned registries. Overall, this study reinforces the need for improved data accuracy and transparency in clinical trial registries and emphasizes the importance of resolving complications faced by users while navigating the registries. Ensuring accurate and comprehensive registration of clinical trials is essential for meta-research and the use of such data by a variety of stakeholders.","PeriodicalId":9114,"journal":{"name":"BMC Medical Research Methodology","volume":null,"pages":null},"PeriodicalIF":3.9000,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medical Research Methodology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12874-024-02336-w","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Clinical trials play a crucial role in biomedical research, and it is important to register them in public registries to ensure transparency and prevent research waste. In this study, we wished to determine what steps need to be taken to identify every clinical trial run in India that has been registered in any of the (non-Indian) World Health Organization-recognised primary registries. Of the 16 registries, we studied all except that of the European Union, which will be studied separately. Two methodologies were employed for each registry, except for four that did not facilitate one or the other method. Methodology A involved downloading all the records in a registry and querying them. Methodology B involved conducting a search via the registry website. Only four registries provided consistent results with both methodologies. Seven registries had different results from the two methodologies. Of these, in four cases, in Methodology A one field indicated that the study ran in India, while another indicated otherwise. The above-mentioned ambiguities should be addressed by the concerned registries. Overall, this study reinforces the need for improved data accuracy and transparency in clinical trial registries and emphasizes the importance of resolving complications faced by users while navigating the registries. Ensuring accurate and comprehensive registration of clinical trials is essential for meta-research and the use of such data by a variety of stakeholders.
临床试验在生物医学研究中发挥着至关重要的作用,在公共登记处登记临床试验对于确保透明度和防止研究浪费非常重要。在这项研究中,我们希望确定需要采取哪些措施来识别在印度进行的、已在世界卫生组织认可的任何(非印度)主要登记处登记的每项临床试验。在这 16 个登记处中,我们研究了除欧盟登记处以外的所有登记处,欧盟登记处将单独研究。每个登记处都采用了两种方法,只有四个登记处没有采用其中一种方法。方法 A 包括下载登记册中的所有记录并进行查询。方法 B 涉及通过登记处网站进行查询。只有四个登记处使用两种方法提供了一致的结果。有 7 个登记册在使用两种方法时结果不同。其中,有四个登记册在 "方法 A "中的一个字段表示研究在印度进行,而另一个字段则表示不在印度进行。相关登记册应解决上述模糊问题。总之,本研究强化了提高临床试验注册数据准确性和透明度的必要性,并强调了解决用户在注册过程中遇到的复杂问题的重要性。确保临床试验登记的准确性和全面性对元研究和各利益相关方使用这些数据至关重要。
期刊介绍:
BMC Medical Research Methodology is an open access journal publishing original peer-reviewed research articles in methodological approaches to healthcare research. Articles on the methodology of epidemiological research, clinical trials and meta-analysis/systematic review are particularly encouraged, as are empirical studies of the associations between choice of methodology and study outcomes. BMC Medical Research Methodology does not aim to publish articles describing scientific methods or techniques: these should be directed to the BMC journal covering the relevant biomedical subject area.