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提高印度早期临床试验的能力。

Increasing early phase clinical trials capacity in India.

作者信息

Cherian Jerin Jose, Poomali Aruvi, Mukherjee Aparna, Gupta Taruna Madan, Medhi Bikash, Mukherjee Shoibal, Sankaranarayanan Alangudi, Saha Nilanjan, Gota Vikram, Gudde Ramachandra Subbaraya, Pahuja Monika, Das Saibal, Chatterjee Nabendu Sekhar, Bose Rubina, Kshirsagar Nilima, Raghuvanshi Rajeev Singh

机构信息

Division of Development Research, Indian Council of Medical Research Headquarters, New Delhi, India.

Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.

出版信息

Commun Med (Lond). 2025 Jul 1;5(1):255. doi: 10.1038/s43856-025-00970-z.

DOI:10.1038/s43856-025-00970-z
PMID:40593320
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12216851/
Abstract

The Indian Council for Medical Research has established the ICMR-Network for Phase 1 Clinical Trials. Here we describe identification of the need to establish the Network and further elaborate on its vision, governance, and operational aspects.

摘要

印度医学研究理事会已建立了ICMR一期临床试验网络。在此,我们阐述建立该网络的必要性,并进一步详细说明其愿景、管理和运营方面的情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d97/12216851/ee1b47f173f3/43856_2025_970_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d97/12216851/1601b2355ba2/43856_2025_970_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d97/12216851/ee1b47f173f3/43856_2025_970_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d97/12216851/1601b2355ba2/43856_2025_970_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d97/12216851/ee1b47f173f3/43856_2025_970_Fig2_HTML.jpg

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本文引用的文献

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Drug development in LMICs: could the emerging Indian model usher the southeast Asian region?低收入和中等收入国家的药物研发:新兴的印度模式能否引领东南亚地区?
Lancet Reg Health Southeast Asia. 2024 Aug 16;29:100464. doi: 10.1016/j.lansea.2024.100464. eCollection 2024 Oct.
2
Cutting-edge CAR-T cancer therapy is now made in India - at one-tenth the cost.前沿的嵌合抗原受体T细胞(CAR-T)癌症疗法如今在印度生产,成本仅为原来的十分之一。
Nature. 2024 Mar;627(8005):709-710. doi: 10.1038/d41586-024-00809-y.
3
A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials.
对2008年至2022年在印度注册的临床试验进行综述,以描述首次人体试验。
Perspect Clin Res. 2024 Jan-Mar;15(1):18-23. doi: 10.4103/picr.picr_124_23. Epub 2023 Oct 16.
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Early phase clinical trials in India: Need & scope.印度的早期临床试验:需求与范围。
Indian J Med Res. 2023 Jan;158(1):17-20. doi: 10.4103/ijmr.ijmr_1688_22.
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Reducing bureaucracy in clinical trials.减少临床试验中的官僚作风。
United European Gastroenterol J. 2022 Nov;10(9):1029-1030. doi: 10.1002/ueg2.12320. Epub 2022 Oct 12.
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Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011-2020).中国大陆过去10年(2011 - 2020年)新药I期临床试验趋势
Front Med (Lausanne). 2021 Dec 17;8:777698. doi: 10.3389/fmed.2021.777698. eCollection 2021.
7
Biopharmaceutical Industry Capability Building in India: Report from a Symposium.印度生物制药产业能力建设:研讨会报告
J Pharm Innov. 2022;17(4):1555-1562. doi: 10.1007/s12247-021-09596-9. Epub 2021 Nov 26.
8
Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial.一种灭活的严重急性呼吸综合征冠状病毒 2 型疫苗(BBV152)的有效性、安全性和批间免疫原性:一项随机、双盲、对照、3 期临床试验的中期结果。
Lancet. 2021 Dec 11;398(10317):2173-2184. doi: 10.1016/S0140-6736(21)02000-6. Epub 2021 Nov 11.
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Reliability of Trial Information Across Registries for Trials With Multiple Registrations: A Systematic Review.多注册试验的注册库间试验信息的可靠性:系统评价。
JAMA Netw Open. 2021 Nov 1;4(11):e2128898. doi: 10.1001/jamanetworkopen.2021.28898.
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Indian J Pharmacol. 2020 Jul-Aug;52(4):272-282. doi: 10.4103/ijp.IJP_24_20.