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在新冠疫情背景下重新审视尼泊尔的临床试验历史与监管机制。

Revisiting the clinical trial history and regulatory mechanisms in Nepal in the context of COVID-19 pandemic.

作者信息

Paudel Suman Sharma, Sapkota Yunima, Gyanwali Pradip, Dhimal Meghnath, Ghimire Namita, Pant Suman, Bhandari Dinesh, Mandal Shrawan Kumar

机构信息

Nepal Health Research Council (NHRC), Nepal.

School of Nursing and Midwifery, Monash University, Australia.

出版信息

Contemp Clin Trials Commun. 2022 Dec;30:101038. doi: 10.1016/j.conctc.2022.101038. Epub 2022 Nov 12.

Abstract

Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.

摘要

尽管几十年前尼泊尔曾开展过关于戊型肝炎疫苗的大规模随机对照试验,但该国在全球临床试验中的参与度明显微不足道。大部分问题归因于缺乏合作、资金和人力资源限制。新冠疫情似乎促使尼泊尔当局产生了紧迫感,导致与国家和国际组织/机构合作开展的临床试验数量大幅增加。2020年1月13日首次检测到新冠病例后,尼泊尔人权委员会的伦理审查委员会(ERB)收到了多项研究提案,随后于2020年7月1日批准了首个针对新冠的临床试验,以研究传统阿育吠陀医学治疗新冠的潜力。很快,其他一些临床试验提案也获得批准并在该国实施,然而尼泊尔政府(GON)的预算分配仅优先用于新冠疫情应急管理和疫苗接种覆盖率。与各国际机构的合作在该国成功开展大规模临床试验中发挥了重要作用,并为未来奠定了基础。在这篇综述文章中,我们介绍了尼泊尔临床试验的最新进展、政府的预算分配以及该国临床研究监管机制,同时也探讨了面临的挑战和未来方向。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e91a/9679273/8e10d2ee8f66/gr1.jpg

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