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"最公平的药物":恢复期血浆作为 SARS-CoV-2 治疗方法的临床研究如何为大流行后公共部门药物开发方法提供有益信息。

"A Most Equitable Drug": How the Clinical Studies of Convalescent Plasma as a Treatment for SARS-CoV-2 Might Usefully Inform Post-Pandemic Public Sector Approaches to Drug Development.

机构信息

UNIVERSITY OF TORONTO, TORONTO, ONTARIO, CANADA.

DALHOUSIE UNIVERSITY, HALIFAX, NOVA SCOTIA, CANADA.

出版信息

J Law Med Ethics. 2024;52(1):80-97. doi: 10.1017/jme.2024.51. Epub 2024 May 31.

Abstract

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

摘要

干预性临床研究表明,恢复期血浆治疗 COVID-19 的资金主要来自公共部门参与者,包括血液服务机构。我们旨在分析恢复期血浆临床研究的过程,以了解除制药行业生物制药研发以外的替代方案,尤其是在公共部门参与者发挥主导作用的情况下。我们对 2020 年至 2021 年期间具有显著影响力的恢复期血浆临床研究进行了一项定性、关键性案例研究。

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