世卫组织国际临床试验注册平台主要注册机构概述。

Ayu Pub Date : 2019-07-01 Epub Date: 2020-08-08 DOI:10.4103/ayu.AYU_62_20
Atul Juneja, Jyotsna Gupta, Neha Yadav, Saurabh Sharma, Yashmin Panchal, Tulsi Adhikari, M Vishnu Vardhana Rao
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引用次数: 4

摘要

世卫组织的国际临床试验注册平台(ICTRP)有17个主要注册中心,收集出现在注册中心的最少试验信息项目集的信息,这些注册中心也得到国际医学杂志编辑委员会的认可。目的:本研究的目的是通过规模、注册领域、标记、审计跟踪、语言、强制性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中心的概况。方法:对所有注册中心的分析是基于国家和地区、建立年份、注册人、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、个体患者数据声明和内容设施的翻译。使用的搜索模式是在线搜索,包括高级搜索,基本搜索以及他们网站上的音频/视频手册。结果:ICTRP有17个主要注册中心,英国的第一个国际标准随机对照试验号(ISRCTN)于2000年启动,最近的一个是黎巴嫩注册中心,于2019年9月启动。在这些注册中心注册的试验从古巴的301项到欧盟临床试验注册中心的53972项不等。世卫组织注册网络中的主要注册中心在功能和做法上各不相同。联机登记册的特点在内容和特征上各不相同,为了在所有不同的登记册之间实现数据质量的协调水平,并在收集数据的标准和数据的验证方面保持平衡,各登记册都遵守ICTRP规定的最低数据集项目。结论:临床研究注册的过程有助于推广研究方法,提高研究水平,特别是对年轻研究人员。它还有助于减少研究的口是心非。
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An overview of primary registries of WHO's international clinical trial registry platform.

Introduction: 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.

Objective: 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.

Methodology: 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.

Results: 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.

Conclusion: 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.

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