An innovative tool to prioritize the assessment of investigational COVID-19 therapeutics: A pilot project.

Lizanne Béïque, Savannah Clarke, Mina Azad, Elaha Sarwar, Margaret Gale-Rowe, Stacy Sabourin, Cheryl Marinsky, Jacqueline Arthur
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Abstract

Background: As the COVID-19 pandemic unfolded, hundreds of investigational COVID-19 therapeutics emerged. Maintaining situational awareness of this extensive and rapidly evolving therapeutic landscape represented an unprecedented challenge for the Public Health Agency of Canada, as it worked to promote and protect the health of Canadians. A tool to triage and prioritize the assessment of these therapeutics was needed.

Methods: The objective was to develop and conduct an initial validation of a tool to identify investigational COVID-19 therapeutics for further review based on an efficient preliminary assessment, using a systematic and reliable process that would be practical to validate, implement and update. Phase 1 of this pilot project consisted of a literature search to identify existing COVID-19 therapeutic assessment prioritization tools, development of the Rapid Scoring Tool (RST) and initial validation of the tool.

Results: No tools designed to rank investigational COVID-19 therapeutics for the purpose of prioritizing their assessment were identified. However, a few publications provided criteria to consider and therapeutic ranking methods, which helped shape the development of the RST. The RST included eight criteria and several descriptors ("characteristics"). A universal characteristic scoring scale from -10 to 10 was developed. The sum of all the characteristic scores yielded an overall benefit score for each therapeutic. The RST appropriately ranked therapeutics using a systematic, reliable and practical approach.

Conclusion: Phase 1 was successfully completed. The RST presents several distinct aspects compared with other tools, including its scoring scale and method, and capacity to factor in incomplete or pending information. It is anticipated that the framework used for the RST will lend itself to use in other dynamic situations involving many interventions.

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一种创新工具,用于优先评估在研 COVID-19 疗法:试点项目。
背景:随着 COVID-19 大流行的发展,出现了数百种 COVID-19 研究疗法。加拿大公共卫生局致力于促进和保护加拿大人的健康,而保持对这一广泛且快速发展的治疗领域的态势感知则是一项前所未有的挑战。我们需要一种工具来对这些疗法进行分流和优先评估:方法:我们的目标是开发并初步验证一种工具,以便在高效初步评估的基础上,利用系统、可靠且易于验证、实施和更新的流程,确定需要进一步审查的 COVID-19 研究性疗法。该试点项目的第一阶段包括文献检索以确定现有的 COVID-19 治疗评估优先级工具、开发快速评分工具 (RST) 以及对该工具进行初步验证:结果:未发现任何旨在对在研 COVID-19 疗法进行排序以确定其评估优先次序的工具。不过,一些出版物提供了考虑标准和治疗排序方法,有助于 RST 的开发。RST 包括八项标准和若干描述符("特征")。制定了一个从 -10 到 10 的通用特征评分表。所有特征得分的总和得出每种疗法的总体效益得分。RST 采用系统、可靠和实用的方法对疗法进行了适当的排序:第一阶段已顺利完成。与其他工具相比,RST 有几个与众不同之处,包括其评分标准和方法,以及考虑不完整或待定信息的能力。预计 RST 所使用的框架可用于其他涉及多种干预措施的动态情况。
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