Adapting to circumstance

FDA, NIH, academic investigators and biopharmaceutical companies are collaborating on the design of an adaptive, randomized controlled trial of Ebola therapies that could be conducted in the U.S. and Liberia, Luciana Borio, FDA assistant commissioner for counterterrorism policy, told BioCentury last week.

The protocol will be a sharp departure from trials planned by Médecins Sans Frontières (MSF), the Wellcome Trust and other non-governmental organizations, which have argued randomized controlled studies are unethical as well as impractical. For Ebola, the control would consist of best supportive care, as no treatments have been approved...