Institute of Bioinformatics and Applied Biotechnology, Bengaluru, Karnataka, India.
PLoS One. 2021 May 11;16(5):e0251191. doi: 10.1371/journal.pone.0251191. eCollection 2021.
It is an ethical and scientific obligation to register each clinical trial, and report its results, accurately, comprehensively and on time. The WHO recognizes 17 public registries as Primary Registries, and has also introduced a set of minimal standards in the International Standards for Clinical Trial Registries (ISCTR) that primary registries need to implement. These standards are categorized into nine sections-Content, Quality and Validity, Accessibility, Unambiguous Identification, Technical Capacity, Administration and Governance, the Trial Registration Data Set (TRDS), Partner registries and Data Interchange Standards. This study compared the WHO's primary registries, and the US's ClinicalTrials.gov, to examine the implementation of ISCTR, with the aim of defining features of an interim ideal registry.
The websites of the 18 registries were evaluated for 14 features that map to one or more of the nine sections of ISCTR, and assigned scores for their variations of these features. The assessed features include the nature of the content; the number and nature of fields to conduct a search; data download formats; the nature of the audit trail; the health condition category; the documentation available on a registry website; etc. The registries received scores for their particular variation of a given feature based on a scoring rationale devised for each individual feature analysed. Overall, the registries received between 27% and 80% of the maximum score of 94. The results from our analysis were used to define a set of features of an interim ideal registry.
To the best of our knowledge, this is the first study to quantify the widely divergent quality of the primary registries' compliance with the ISCTR. Even with this limited assessment, it is clear that some of the registries have much work to do, although even a few improvements would significantly improve them.
准确、全面、及时地登记和报告每一项临床试验结果，是一项道德和科学义务。世界卫生组织（WHO）认可了 17 个公共注册机构作为主要注册机构，并在《临床试验国际注册标准》（ISCTR）中引入了一套主要注册机构需要实施的最低标准。这些标准分为九个部分——内容、质量和有效性、可及性、明确标识、技术能力、管理和治理、试验注册数据集（TRDS）、伙伴注册机构和数据交换标准。本研究比较了 WHO 的主要注册机构和美国的 ClinicalTrials.gov，以检查 ISCTR 的实施情况，旨在确定一个临时理想注册机构的特征。
评估了 18 个注册机构的网站，评估了 14 个与 ISCTR 的九个部分之一或多个部分相对应的特征，并为这些特征的变化分配了分数。评估的特征包括内容的性质；进行搜索的字段数量和性质；数据下载格式；审核跟踪的性质；健康状况类别；注册机构网站上可用的文档等。根据为每个分析的单个特征制定的评分原理，各注册机构根据其特定特征的变化获得了特定分数。总体而言，这些注册机构获得了 94 分满分的 27%至 80%。我们的分析结果用于定义一个临时理想注册机构的特征集。
据我们所知，这是第一项量化主要注册机构遵守 ISCTR 的质量差异的研究。即使进行了这种有限的评估，也很明显，一些注册机构还有很多工作要做，尽管即使是一些改进也会显著改善它们。
