Statistical considerations for a trial of Ebola virus disease therapeutics

Clinical Trials : Journal of the Society for Clinical Trials
Michael A ProschanDionne Price

Abstract

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.

References

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Citations

May 20, 2016·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Dietrich Haubenberger, David B Clifford
Oct 13, 2016·The New England Journal of Medicine·UNKNOWN PREVAIL II Writing GroupDenis Malvy
Mar 10, 2017·PLoS Neglected Tropical Diseases·John Whitehead, Peter Horby
Nov 28, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Susan S EllenbergKeith P W J McAdam
Jan 16, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Tansy EdwardsUNKNOWN Ebola_Tx Consortium
May 4, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Michael A Proschan, Lori E Dodd
May 6, 2016·Clinical Trials : Journal of the Society for Clinical Trials·John Whitehead
Jan 16, 2016·Clinical Trials : Journal of the Society for Clinical Trials·H Clifford LaneAnthony S Fauci
Nov 28, 2019·The New England Journal of Medicine·Sabue MulanguUNKNOWN PALM Consortium Study Team
Jul 1, 2017·Therapeutic Innovation & Regulatory Science·Matthew Carl Kirchoff, Jerome F Pierson
Mar 5, 2019·Global Pediatric Health·Megan HeereStephen Aronoff
Jul 6, 2020·Clinical Therapeutics·Elias Laurin MeyerFranz König
Apr 19, 2021·The Lancet Global Health·Jay J H ParkEdward J Mills
Jul 1, 2021·Statistics in Biopharmaceutical Research·Nigel StallardThomas Jaki
Jul 1, 2021·Statistics in Biopharmaceutical Research·William R ZameMihaela van der Schaar

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Software Mentioned

Zmapp
oSOC

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