Completion of clinical trials in light of COVID-19
Talha Burki
Abstract
Over the past few months, more than 80 000 Americans with COVID-19 have been treated with convalescent plasma, under an expanded access programme. The programme was discontinued on Aug 23, 2020, after the US Food and Drug Administration (FDA) authorised the emergency use of convalescent plasma in hospitalised patients with COVID-19. “This product may be effective in treating COVID-19”, stated the FDA. “The known and potential benefits...outweigh the known and potential risks.” The agency had good reason to sound so cautious.
Topics & Concepts
MedicineFood and drug administrationCoronavirus disease 2019 (COVID-19)Convalescent plasma2019-20 coronavirus outbreakSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Agency (philosophy)Expanded accessIntensive care medicineClinical trialPandemicDrug approvalDrugFamily medicineMedical emergencyVirologyPharmacologyInternal medicineOutbreakDiseasePhilosophyInfectious disease (medical specialty)EpistemologyCOVID-19 Clinical Research StudiesSARS-CoV-2 and COVID-19 ResearchPharmaceutical studies and practices