Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.
Keywords: cytomegalovirus; antiviral drugs; immunocompromised; regulatory; transplant; viral infection.
Published by Oxford University Press for the Infectious Diseases Society of America 2020.