Ethical challenges of prospective clinical trials during the COVID-19 pandemic.

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has created an unprecedented opportunity to reimagine clinical research. While much has been written about the challenges associated with generating real-world evidence during the COVID-19 pandemic, comparatively little attention has been paid to the ethical challenges facing patients, clinicians, researchers, and regulatory bodies. AREAS COVERED In this manuscript, we examine these challenges through the lens of informed consent and explore how the consenting process changes as our understanding of the disease is altered. EXPERT OPINION We also suggest ways to limit these ethical hurdles through the use of embedded pragmatic clinical trials, which generate real-world data without the limitations associated with observational trials or the resources and lack of generalizability that are obstacles to conducting conventional randomized clinical trials. We argue that clinical research must become more nimble, and must include embedded researchers to ensure that relevant questions and ethical issues are properly addressed.