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COVID-19 需要创新、监管和严谨:Amaylid Arteaga-García,医学博士、理学硕士,国家临床试验协调中心(CENCEC)主任。

COVID-19 Requires Innovation, Regulation and Rigor: Amaylid Arteaga-García MD MS Director, National Clinical Trials Coordinating Center (CENCEC).

出版信息

MEDICC Rev. 2021 Apr;23(2):9. doi: 10.37757/MR2021.V23.N2.16. Epub 2021 Apr 30.

DOI:10.37757/MR2021.V23.N2.16
PMID:33974607
Abstract

The effects and implications of COVID-19 are global, comprehensive and long-term. The pandemic has exposed inequities, the fragility of economic and political systems, and in many cases, skewed priorities. Population health, not to mention planetary health, is suffering as a result. Nevertheless, the global health crisis in which we are embroiled has provided opportunities for effective collaboration, scientific innovation and real dialog around health and equity. Dr Amaylid Arteaga-García, director of Cuba's National Clinical Trials Coordinating Center (CENCEC), emphasized these opportunities when discussing Cuba's clinical trials in times of COVID-19. Founded in 1991 in response to the groundbreaking research emerging from the country's biopharmaceutical sector-including the first safe, effective vaccine against serogroup B meningococcal disease, VA-MENGOC-BC in 1989 and a recombinant vaccine against hepatitis B, Heberbiovac in 1990-CENCEC now coordinates some 100 clinical trials annually, many of them multi-site trials involving thousands of volunteers. Little did Dr Arteaga García know what problems lurked when she became CENCEC director in 2019. In February 2020, Cuba implemented its National COVID-19 Prevention & Control Plan. This included a scientific Innovation Committee tasked with evaluating promising projects, products and research that might be used in the health system to control and treat COVID-19. This approach taps into two of Cuba's strengths: biotechnology and primary health care. Given the volume and complexity of COVID-19 clinical trials, Dr Arteaga.

摘要

新冠疫情的影响和意义是全球性的、全面的和长期的。这场大流行暴露了不平等现象、经济和政治体系的脆弱性,而且在许多情况下,还扭曲了优先事项。因此,人口健康,更不用说地球健康,正在受到影响。然而,我们深陷的全球卫生危机为有效合作、科学创新和围绕健康与公平进行真正对话提供了机会。古巴国家临床研究协调中心(CENCEC)主任 Amaylid Arteaga-García 博士在讨论古巴在新冠疫情期间的临床试验时强调了这些机会。CENCEC 成立于 1991 年,是为了应对该国生物制药部门涌现的开创性研究而成立的,其中包括 1989 年第一个安全有效的 B 群脑膜炎球菌疾病疫苗 VA-MENGOC-BC 和 1990 年乙型肝炎重组疫苗 Heberbiovac。CENCEC 目前每年协调约 100 项临床试验,其中许多是涉及数千名志愿者的多地点试验。当 Arteaga García 博士于 2019 年担任 CENCEC 主任时,她并不知道潜伏着什么问题。2020 年 2 月,古巴实施了国家新冠疫情预防和控制计划。其中包括一个科学创新委员会,负责评估可能用于卫生系统控制和治疗新冠疫情的有前途的项目、产品和研究。这种方法利用了古巴的两个优势:生物技术和初级卫生保健。考虑到新冠疫情临床试验的数量和复杂性,Arteaga 博士。

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