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大流行时代的临床试验:什么适合目标?

Clinical trials in the pandemic age: What is fit for purpose?

作者信息

Hartman Dan, Heaton Penny, Cammack Nick, Hudson Ian, Dolley Shawn, Netsi Elena, Norman Thea, Mundel Trevor

机构信息

Bill & Melinda Gates Foundation, Seattle, Washington, 98109, USA.

Bill & Melinda Gates Medical Research Institute, Cambridge, MA, 02138, USA.

出版信息

Gates Open Res. 2020 Jun 9;4:58. doi: 10.12688/gatesopenres.13146.1. eCollection 2020.

Abstract

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.

摘要

至关重要的是要确保新冠病毒研究能为科学问题提供清晰且及时的答案,这些答案将引导我们找到适用于所有全球区域的可扩展解决方案。开展试验面临的重大挑战包括管理疫情的公共政策、公共卫生和临床能力、旅行与移民,以及检测和基础设施的可用性。这些因素导致不同地点的患者数量出现波动,干扰了预测试验何时或是否能达到招募目标的能力。重点还必须放在理解如何公平地提供这些干预措施上,确保干预措施惠及最需要的人群,无论是资源匮乏地区的患者还是弱势群体。我们推出了一个网站,供比尔及梅琳达·盖茨基金会、惠康信托基金会以及新冠治疗加速器的其他资助者使用,这些资助者接受未来临床研究的提案。该门户网站能够对临床研究申请进行评估,重点关注最有可能产生有益结果的研究质量以及已完成的研究。

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