From COVID-19 research to vaccine application: why might it take 17 months not 17 years and what are the wider lessons?
From COVID-19 research to vaccine application: why might it take 17 months not 17 years and what are the wider lessons?
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DOI：
10.1186/s12961-020-00571-3
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发表时间：
2020-06-08
影响因子：
4
通讯作者：
Grant, Jonathan
中科院分区：
文献类型：
--
作者：
Hanney, Stephen R.;Wooding, Steven;Grant, Jonathan
人们常说，将医学研究从实验室转移到临床需要17年的时间。在冠状病毒（COVID-19）的世界里，这种时间滞后让人无法忍受。在这种特殊的情况下，几年能变成几个月吗？如果是这样，当危机缓解时，这些经验教训能被用来加速医学研究吗？为了衡量健康和生物医学研究中的时间滞后并确定减少它们的方法，我们（在2015年）开发并发布了一个矩阵，该矩阵由从发现研究到开发产品、政策和实践的转化过程中的重叠轨道（或阶段/阶段）组成。矩阵通过突出(1)沿着每个轨道和(2)从一个轨道到另一个轨道（例如，从发现轨道到人类研究轨道）发展研究（及其翻译）所需的时间和行动来辅助分析。我们注意到减少时间滞后的四种主要方法，即增加资源、并行工作、在风险中启动或工作以及改进流程。将这些方法与矩阵一起研究，有助于解释全球为开发2019年新型冠状病毒SARS-CoV-2 （COVID-19的病原体）疫苗所做的巨大努力。在发现/基础研究和人类研究方面，通过大规模资助、并行开展工作（在全球不同的团队之间以及通过在重叠的领域开展工作）、承担比平时更大的（但不成比例的）安全风险以及采用各种新流程，正在取得快速进展。一些团队的重叠工作包括继续进行动物研究，同时将候选疫苗进入第一阶段试验，同时规划其第二阶段试验。可获得的额外资金有助于减少行动如此迅速所带来的一些通常的财务风险。在对安全性、剂量和疗效进行越来越大规模的人体试验的过程中，在经常具有挑战性的公共政策和临床轨道上并行开展工作将是至关重要的。因此，管理和报销机构正在开始并准备迅速采取行动，将证明安全有效的疫苗迅速应用于一般人群。使用矩阵（根据需要进行修改）监测COVID-19疫苗的开发可以帮助确定哪些加快开发和部署的方法可以在未来更广泛地有效应用。
It is often said that it takes 17 years to move medical research from bench to bedside. In a coronavirus disease (COVID-19) world, such time-lags feel intolerable. In these extraordinary circumstances could years be made into months? If so, could those lessons be used to accelerate medical research when the crisis eases? To measure time-lags in health and biomedical research as well as to identify ways of reducing them, we developed and published (in 2015) a matrix consisting of overlapping tracks (or stages/phases) in the translation from discovery research to developed products, policies and practice. The matrix aids analysis by highlighting the time and actions required to develop research (and its translation) both (1) along each track and (2) from one track to another, e.g. from the discovery track to the research-in-humans track. We noted four main approaches to reducing time-lags, namely increasing resources, working in parallel, starting or working at risk, and improving processes. Examining these approaches alongside the matrix helps interpret the enormous global effort to develop a vaccine for the 2019 novel coronavirus SARS-CoV-2, the causative agent of COVID-19. Rapid progress in the discovery/basic and human research tracks is being made through a combination of large-scale funding, work being conducted in parallel (between different teams globally and through working in overlapping tracks), working at greater (but proportionate) risk to safety than usual, and adopting various new processes. The overlapping work of some of the teams involves continuing animal research whilst entering vaccine candidates into Phase I trials alongside planning their Phase II trials. The additional funding available helps to reduce some of the usual financial risks in moving so quickly. Going forward through the increasingly large human trials for safety, dosage and efficacy, it will be vital to overlap work in parallel in the often challenging public policy and clinical tracks. Thus, regulatory and reimbursement bodies are beginning and preparing rapid action to pull vaccines proving to be safe and effective through to extraordinarily rapid application to the general population. Monitoring the development of a COVID-19 vaccine using the matrix (modified as necessary) could help identify which of the approaches speeding development and deployment could be usefully applied more widely in the future.