In response to the
COVID-19 pandemic, large-scale research and
pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based
COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of
molnupiravir, a novel
antiviral medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of
molnupiravir through the large-scale Platform Adaptive trial of Novel
antiviRals for eArly treatMent of
COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of
molnupiravir complicate standard approaches to clinical
equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new
COVID-19 and other
therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers.