Juneja Atul, Gupta Jyotsna, Yadav Neha, Sharma Saurabh, Panchal Yashmin, Adhikari Tulsi, Rao M Vishnu Vardhana
ICMR‑National Institute of Medical Statistics, New Delhi, India.
Clinical Trials Registry‑India, ICMR‑National Institute of Medical Statistics, New Delhi, India.
Ayu. 2019 Jul-Sep;40(3):141-146. doi: 10.4103/ayu.AYU_62_20. Epub 2020 Aug 8.
WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors.
The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry‑India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure.
The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website.
There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP.
The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research.
世界卫生组织的国际临床试验注册平台（ICTRP）有17个主要注册机构，它们收集注册中出现的试验信息的最低项目集信息，这些注册机构也得到了国际医学期刊编辑委员会的认可。
本研究的目的是通过规模、注册领域、标记、审计跟踪、语言、强制要求和结果披露等特征，描述包括印度临床试验注册中心（CTRI）在内的所有主要注册机构的概况。
所有注册机构的概况分析基于国家和地区、成立年份、注册者、标记、利益冲突、语言、文件、结果披露、研究类型、注册模式、注册授权、质量检查方法、个体患者数据声明以及内容翻译设施。使用的搜索模式是在线搜索，包括高级搜索、基本搜索以及从其网站上的音频/视频手册中搜索。
ICTRP有17个主要注册机构，第一个是2000年成立的英国国际标准随机对照试验编号（ISRCTN），最新的是2019年9月的黎巴嫩注册机构。在这些注册机构注册的试验数量从古巴的301项到欧盟临床试验注册中心的53972项不等。世界卫生组织注册网络中的主要注册机构在功能和实践方面各不相同。在线注册机构的特点在内容和功能上有所不同，为了在所有不同的注册机构中实现协调一致的数据质量水平，并在收集的数据标准和数据验证之间保持平衡，各注册机构都遵循ICTRP规定的最低数据集项目。
临床研究的注册过程有助于推广研究方法，提高研究标准，特别是在年轻研究人员中。它还有助于减少研究的重复性。
