印度临床试验阶段及其注册:系统综述

D. Pathak, S. Sonawane, Jivan G. Patil, Diptanshu S. Kasar, Sonali R. Chavan, Nikita Shahane, Priya M. Gadak, P. R. Shinde, Tejaswi D. Kandalkar
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引用次数: 0

摘要

撰写这篇综述文章的基本原理是介绍临床试验,其阶段和印度临床研究的当前情况。本文就临床试验阶段作一简要介绍。读者可以找到循序渐进的试验过程,政府监管机构对确保实验研究中受试者的安全起着重要作用,并有适当的方案和整个实验研究的批准。本文介绍了伦理委员会的作用、研究者和发起人的责任以及DCGI的工作流程和研究规定。本文还对临床试验中的CDSCO、ICH-GCP政府机构等进行了探讨。临床试验在服务公众健康和开发新的有希望的候选药物治疗疾病方面发挥着至关重要的作用。新的候选药物和治疗方法提高了患者的质量和寿命。目前,生物医学研究中临床试验的数量有所增加,因此迫切需要使试验研究的透明度和易于获得性对一般人来说。因此,CTRI的发展已经完成。监管当局在试验中严格观察指导方针是否得到了适当的遵守。及时修改监管指导方针。最近对试验期间严重伤害和知情同意书进行了修改。这篇评论文章为读者提供了所有重要的东西,让他们对印度的临床试验有足够的了解,它是如何进行的,哪个监管机构参与临床试验等。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Trial Phases and their Registration in India: A Systematic Review
The rationale behind writing this review article is to give an introduction to the clinical trial, its phases and the current scenario in clinical research in India. This article gives a brief idea about the clinical trial phases. The reader can find the process of trial in step-by-step manner with the government regulatory body that has a major role to ensure the safety of the subject involved in the experimental study, with appropriate protocol and approval of the whole experimental study. This paper describes the role of the ethics committee, the investigator and sponsors’ responsibilities along with DCGI workflow, regulations of study. This study also discusses what is CDSCO, ICH-GCP government body in clinical trials etc. The clinical trial has a crucial role in serving good health to the public and developing new promising drug candidates in the treatment of diseases. The new drug candidate and therapy enhance the quality and lifespan of the patient. Nowadays the number of clinical trials has increased in biomedical research so there is a huge need to make transparency and easy accessibility of trial studies to general people. Hence, the development of CTRI has been done. The regulatory authority strictly observes whether the guidelines are properly followed in trial or not. The regulatory guidelines are modified timely. The serious injury during trial and informed consent form are recently modified. This review article put all the essential things for the reader to get enough idea about a clinical trial in India, how it is conducted, which regulatory body involved in clinical trial etc.
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来源期刊
Bioscience Biotechnology Research Communications
Bioscience Biotechnology Research Communications BIOTECHNOLOGY & APPLIED MICROBIOLOGY-
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