Leveraging implementation science in clinical trials of vaccines in the global south

IF 50 1区 医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Nature Medicine Pub Date : 2025-03-05 DOI:10.1038/s41591-025-03546-5
Abdu A. Adamu, Duduzile Ndwandwe, Charles S. Wiysonge
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在南半球的疫苗临床试验中利用实施科学
传染病对全球经济和政治产生重大影响,COVID-19大流行就是一个例子,因此,研究性疫苗和免疫技术往往需要在尽可能短的时间内迅速开发和采用,以供人类使用。实现这一目标的一种方法是,从临床开发的早期阶段,到监管部门的批准和临床使用,积极利用实施科学。对实施科学的需求适用于疫苗,也适用于能够提高疫苗接种覆盖率的创新或技术,例如微针贴片1,冈比亚的一项早期临床试验已经证明了提供麻疹和风疹疫苗的安全性和免疫原性1。生物医学科学始终存在这样的风险,即疫苗和免疫相关创新等研究性产品被困在研究与实践之间的鸿沟中。实施科学的定义是“对方法的科学研究,以促进系统地将研究结果和其他循证实践纳入日常实践,从而提高卫生服务的质量和有效性”2,它的出现是由于需要缩短卫生干预措施的知识差距3。这一研究领域促进了对背景及其如何影响实施结果的更好理解,并有几个多学科和理论知情的框架和模型,用于引导多方面的复杂过程3。虽然实施科学研究主要集中在转化科学连续体的T3阶段(转化为实践)和T4阶段(转化为社区),但它也可以应用于临床试验的早期阶段,即T1阶段(转化为人体)和T2阶段(转化为患者),以提高试验的成功和及时执行。
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来源期刊
Nature Medicine
Nature Medicine 医学-生化与分子生物学
CiteScore
100.90
自引率
0.70%
发文量
525
审稿时长
1 months
期刊介绍: Nature Medicine is a monthly journal publishing original peer-reviewed research in all areas of medicine. The publication focuses on originality, timeliness, interdisciplinary interest, and the impact on improving human health. In addition to research articles, Nature Medicine also publishes commissioned content such as News, Reviews, and Perspectives. This content aims to provide context for the latest advances in translational and clinical research, reaching a wide audience of M.D. and Ph.D. readers. All editorial decisions for the journal are made by a team of full-time professional editors. Nature Medicine consider all types of clinical research, including: -Case-reports and small case series -Clinical trials, whether phase 1, 2, 3 or 4 -Observational studies -Meta-analyses -Biomarker studies -Public and global health studies Nature Medicine is also committed to facilitating communication between translational and clinical researchers. As such, we consider “hybrid” studies with preclinical and translational findings reported alongside data from clinical studies.
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