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Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii
Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii
IP Theory
Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.
‘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, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway
‘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, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway
Articles, Book Chapters, & Popular Press
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 …