亚洲临床试验信息披露现状

Q2 Health Professions

Medical Writing Pub Date : 2023-09-22 DOI:10.56012/vxbm4667

Zuo Yen Lee

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引用次数: 0

摘要

过去十年来，亚洲的透明度和信息披露状况一直在迅速发展。在临床试验注册方面，中国于2013年启动了国家注册网站ChinaDrugTrials.org.cn;韩国于2019年通过食品药品安全部(MFDS)引入了新的临床试验披露平台;而日本在2020年将其现有的三个主要注册中心统一为一个临床试验注册中心——日本临床试验注册中心(jRCT)。我们概述了中国、日本、韩国和台湾4个亚洲国家的临床试验注册和试验结果披露实践。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Current clinical trial disclosure landscape in Asia

The transparency and disclosure landscape in Asia has been rapidly evolving during the past decade. With respect to clinical trial registries, China launched its national registry, ChinaDrugTrials.org.cn, in 2013; South Korea introduced the new clinical trial disclosure platform through its Ministry of Food and Drug Safety (MFDS) in 2019; whilst Japan unified its three existing primary registries into a single clinical trial registry – Japan Registry of Clinical Trials (jRCT) – in 2020. We provide an overview of the national clinical trial registries and the trial results disclosure practices for 4 Asian countries – China, Japan, South Korea, and Taiwan.

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来源期刊

Medical Writing Health Professions-Medical Terminology

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.