Scientific Publications by FDA Staff

Clin Trials 2016 Feb;13(1):39-48

Statistical considerations for a trial of Ebola virus disease therapeutics.

Proschan MA, Dodd LE, Price D

The 2014 West African outbreak of Ebola virus ravaged Liberia, Sierra Leone, and Guinea, causing hemorrhagic fever and death. The need to identify effective therapeutics was acute. The usual drug development paradigm of phase I, followed by phase II, and then phase III trials would take too long. These and other factors led to the design of a clinical trial of Ebola virus disease therapeutics that differs from more conventional clinical trial designs. This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it.