在印度进行临床试验的监管发展。

IF 1.1 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Global Health Epidemiology and Genomics Pub Date : 2016-02-23 eCollection Date: 2016-01-01 DOI:10.1017/gheg.2015.5
R Roy Chaudhury, D Mehta
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引用次数: 5

摘要

在印度最高法院于2013年制定了严格的条件后,印度的临床研究有所下降。法院的命令是在该国临床试验中突出的违规行为之后发出的。本文重点介绍了印度监管机构中央药物标准控制组织为遵守这些指示所采取的步骤。这些措施有三种:加强监管机构、保护参与者安全、为发起人和调查人员创造监管确定性。例子包括对伦理委员会进行大规模培训,制定关于补偿和知情同意过程的视听记录的详细准则,以及缩短处理申请所需的时间。预计这些措施将激发人们对恢复急需的临床研究的信心。
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Regulatory developments in the conduct of clinical trials in India.

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

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来源期刊
Global Health Epidemiology and Genomics
Global Health Epidemiology and Genomics PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
1.40
自引率
0.00%
发文量
10
审稿时长
20 weeks
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