Document Type

Article

Publication Date

2023

Keywords

Convalescent Plasma, Randomized Controlled Trials, Clinical Trials, Public Sector, Innovation, Pharmaceutical Industry

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. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and public funding and infrastructure. Clinical studies also served to build public sector and health system capacity and generate clinical trials and blood services infrastructure. Though convalescent plasma represents a failed COVID-19 treatment, key insights from these studies can be used to enhance the likelihood of success of future models of biopharmaceutical production, designed in the service of ensuring equitable access to biopharmaceuticals, should the political will and financing to support such models someday follow.

Comments

This article will be published in a revised form in The Journal of Law, Medicine & Ethics. This version is free to view and download for private research ad study only. Not for re-distribution, re-sale, or use in derivative works.

© Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Funding declaration: This work was funded by the Social Science and Humanities Research Council (SSHRC) of Canada through a Partner Engage Grant and the MITACS Accelerate Program in partnership with Canadian Blood Services. MH holds funding from the Canadian Institutes of Health Research (CIHR PJT 156256) and has been awarded a chair in Applied Public Health, which is funded by the CIHR and the Public Health Agency of Canada.

Conflict of Interests: QG, CC, RA, and KH declare no conflicts of interest. MH reports being a member of the Patented Medicine Prices Review Board, Canada’s national drug price regulator, and receiving honoraria from the Board for his service.

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