Convalescent Plasma, Randomized Controlled Trials, Clinical Trials, Public Sector, Innovation, Pharmaceutical Industry
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.
Quinn Grundy et al, "‘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" (2023) JL Medicine & Ethics [forthcoming in 2023].