Institute of Bioinformatics and Applied Biotechnology, Bengaluru, Karnataka, India.
Aganitha Cognitive Solutions, Hyderabad, Telangana, India.
BMC Med Res Methodol. 2024 Sep 12;24(1):201. doi: 10.1186/s12874-024-02336-w.
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起着至关重要的作用，将其在公共注册机构中进行注册以确保透明度并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步骤来识别在印度进行的所有已在任何（非印度）世界卫生组织认可的主要注册机构中注册的临床试验。我们研究了除欧洲联盟注册机构（将单独进行研究）之外的 16 个注册机构中的所有注册机构。
除了四个注册机构不允许使用一种或另一种方法外，每个注册机构都采用了两种方法。方法 A 涉及下载注册机构中的所有记录并对其进行查询。方法 B 涉及通过注册机构网站进行搜索。
只有四个注册机构的两种方法提供的结果一致。七种注册机构的两种方法的结果不同。在这七种注册机构中，有四种情况在方法 A 中，一个字段表明该研究在印度进行，而另一个字段则表明并非如此。
上述歧义应由有关注册机构解决。总的来说，这项研究强调了临床试验注册机构需要提高数据准确性和透明度，并强调了解决用户在浏览注册机构时遇到的并发症的重要性。确保临床试验的准确和全面注册对于元研究和各种利益相关者使用此类数据至关重要。
