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印度临床试验注册:概述与新进展

Clinical Trials Registry - India: An overview and new developments.

作者信息

Vardhana Rao M Vishnu, Maulik Mohua, Gupta Jyotsna, Panchal Yashmin, Juneja Atul, Adhikari Tulsi, Pandey Arvind

机构信息

Clinical Trials Registry - India, ICMR-National Institute of Medical Statistics, New Delhi, India.

出版信息

Indian J Pharmacol. 2018 Jul-Aug;50(4):208-211. doi: 10.4103/ijp.IJP_153_18.

DOI:10.4103/ijp.IJP_153_18
PMID:30505058
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6234713/
Abstract

The Clinical Trials Registry - India (CTRI), launched over 10 years ago, is a free, searchable online platform for registration of clinical trials being conducted in India and as well as countries which do not have a Primary Registry of their own. The objective of the present article is to appraise the current status and the new developments of CTRI, which registers all types of clinical studies, including postgraduate theses. The CTRI which was until now allowing both prospective and retrospective registration is moving towards only prospective trial registration. From April 1, 2018, only those trials where the first patient enrollment has not yet commenced will be registered. Further, the CTRI is in the process of implementing structured summary results disclosure of all interventional clinical trials in the near future.

摘要

印度临床试验注册中心(CTRI)于10多年前成立,是一个免费的、可搜索的在线平台,用于注册在印度以及没有本国主要注册机构的国家开展的临床试验。本文的目的是评估CTRI的现状和新进展,该中心注册所有类型的临床研究,包括研究生论文。CTRI此前允许前瞻性和回顾性注册,目前正朝着仅前瞻性试验注册的方向发展。自2018年4月1日起,仅对首位患者尚未入组的试验进行注册。此外,CTRI正在推进在不久的将来对所有干预性临床试验实施结构化总结结果披露。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/9f5d22dfeff3/IJPharm-50-208-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/b3e1f02ebdc9/IJPharm-50-208-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/8cc464ba616a/IJPharm-50-208-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/9f5d22dfeff3/IJPharm-50-208-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/b3e1f02ebdc9/IJPharm-50-208-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/8cc464ba616a/IJPharm-50-208-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2acb/6234713/9f5d22dfeff3/IJPharm-50-208-g003.jpg

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Publication of studies registered in Clinical Trials Registry of India: An audit of mood disorder research protocols from 2009-2019.在印度临床试验注册中心注册的研究成果发布:对2009年至2019年情绪障碍研究方案的审计
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Clinical Trials Registry - India: A decadal perspective.

本文引用的文献

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Strengthening ethics in clinical research.加强临床研究中的伦理规范。
Indian J Med Res. 2011 Mar;133(3):339-40.
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Clinical trial registration gains momentum in India.临床试验注册在印度蓬勃发展。
Indian J Med Res. 2009 Jul;130(1):85-6.
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Statement on publishing clinical trials in Indian biomedical journals.关于在印度生物医学期刊上发表临床试验的声明。
临床试验注册印度:十年展望。
Indian J Pharmacol. 2020 Jul-Aug;52(4):272-282. doi: 10.4103/ijp.IJP_24_20.
Indian J Med Res. 2008 Feb;127(2):104-5.
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N Engl J Med. 2004 Sep 16;351(12):1250-1. doi: 10.1056/NEJMe048225. Epub 2004 Sep 8.
9
Paroxetine (Paxil, Seroxat): increased risk of suicide in pediatric patients.帕罗西汀(帕罗西汀片、赛乐特):儿科患者自杀风险增加。
CMAJ. 2003 Sep 2;169(5):446.
10
Johns Hopkins embroiled in fresh misconduct allegations.约翰·霍普金斯大学卷入新的不当行为指控。
Nature. 2001 Aug 2;412(6846):466. doi: 10.1038/35087715.