Déjà vu all over again? Monkeypox and the urgent need for randomised controlled trials.

ABSTRACT

5 months into the monkeypox epidemic, there are no proven therapies and no comparative safety and efficacy data in the treatment of affected individuals. The question remains whether we, as a scientific and medical community, will apply the lessons learned from the past decade of outbreaks that well conducted randomised controlled trials can be ethically, safely, and efficiently performed to guide clinical decision making so that the right drug is used for the right patient at the right time. Furthermore, the robust level of evidence from randomised controlled trials is highly relevant to advocating for equitable access to new treatments in low-income and middle-income countries. As with COVID-19, we need to pair optimal supportive care with rigorously designed double-blind randomised controlled trials to elucidate safe and effective therapies for monkeypox. The need remains for the funding and development of predesigned, adaptive trial protocols for diseases with epidemic or pandemic potential that can be timely pulled off the shelf and launched early in an outbreak, leveraging ready clinical trial networks and infrastructure for rapid discovery and implementation of new treatments.