Equipoise and research in the current COVID-19 pandemic

ABSTRACT

A review. Equipoise in translational research and in clin. practice means there is essential uncertainty in terms of benefit or risk resulting from the use of a particular therapy. The interplay between equipoise and ethics form one of the essential foundations of clin. research;one notable clin. ethicist succinctly characterized equipoise as "a clin. necessary condition in all cases of clin. research.". In the setting of COVID-19, there are no therapies with known effect. We rely on supportive care only. To be clear 100% of pharmacol. therapies in use today are not established for this disease and no evidence exists that any treatment is more helpful than harmful, a critical premise underlying the ethical practice of medicine. Fundamentally, a firm evidence base on which to decide the appropriate path for the patients in our care is lacking, and the abundance of anecdote -- normally a hypothesis generation mechanism -- can get in the way of our societal need to understand the risks and benefits of untested therapies through well controlled, randomized trials. The challenges facing us in the current pandemic are undeniably urgent, but do not preclude systematic and thorough evaluation of risk and benefit. This call is echoed by others advocating for design and completion of high-quality trials to evaluate the safety and efficacy of all therapies under consideration for COVID-19.