Literature DB >> 26768567

Statistical considerations for a trial of Ebola virus disease therapeutics.

Michael A Proschan1, Lori E Dodd2, Dionne Price3.   

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.
© The Author(s) 2016.

Entities:  

Keywords:  Barnard’s test; Bayesian methods; Fisher’s exact test; beta-binomial distribution; conditional power; emerging infectious diseases; group-sequential monitoring; non-informative prior

Mesh：

Substances：

Year:  2016        PMID： 26768567      PMCID： PMC4767714          DOI： 10.1177/1740774515620145

Source DB:  PubMed          Journal:  Clin Trials        ISSN： 1740-7745            Impact factor:   2.486


  8 in total

1.  Infectious Diseases. Ebola vaccine trials raise ethical issues.

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2.  Designs for group sequential tests.

Authors:  T R Fleming; D P Harrington; P C O'Brien
Journal:  Control Clin Trials       Date:  1984-12

3.  Applicability of sample size calculations based on a comparison of proportions for use with the logrank test.

Authors:  M H Gail
Journal:  Control Clin Trials       Date:  1985-06

4.  A multiple testing procedure for clinical trials.

Authors:  P C O'Brien; T R Fleming
Journal:  Biometrics       Date:  1979-09       Impact factor: 2.571

5.  Repeated assessment of results in clinical trials of cancer treatment.

Authors:  J L Haybittle
Journal:  Br J Radiol       Date:  1971-10       Impact factor: 3.039

6.  Combining one-sample confidence procedures for inference in the two-sample case.

Authors:  Michael P Fay; Michael A Proschan; Erica Brittain
Journal:  Biometrics       Date:  2014-10-01       Impact factor: 2.571

7.  Evaluating clinical trial designs for investigational treatments of Ebola virus disease.

Authors:  Ben S Cooper; Maciej F Boni; Wirichada Pan-ngum; Nicholas P J Day; Peter W Horby; Piero Olliaro; Trudie Lang; Nicholas J White; Lisa J White; John Whitehead
Journal:  PLoS Med       Date:  2015-04-14       Impact factor: 11.069

8.  Ebola virus vaccine trials: the ethical mandate for a therapeutic safety net.

Authors:  Steve E Bellan; Juliet R C Pulliam; Jonathan Dushoff; Lauren Ancel Meyers
Journal:  BMJ       Date:  2014-12-10
  8 in total
  11 in total

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Authors:  Richard T Davey; Lori Dodd; Michael A Proschan; James Neaton; Jacquie Neuhaus Nordwall; Joseph S Koopmeiners; John Beigel; John Tierney; H Clifford Lane; Anthony S Fauci; Moses B F Massaquoi; Foday Sahr; Denis Malvy
Journal:  N Engl J Med       Date:  2016-10-13       Impact factor: 91.245

2.  Considerations for Use of Investigational Drugs in Public Health Emergencies.

Authors:  Matthew Carl Kirchoff; Jerome F Pierson
Journal:  Ther Innov Regul Sci       Date:  2016-01-01       Impact factor: 1.778

Review 3.  Clinical Trials in Neurovirology: Successes, Challenges, and Pitfalls.

Authors:  Dietrich Haubenberger; David B Clifford
Journal:  Neurotherapeutics       Date:  2016-07       Impact factor: 7.620

4.  Rigorous Clinical Trial Design in Public Health Emergencies Is Essential.

Authors:  Susan S Ellenberg; Gerald T Keusch; Abdel G Babiker; Kathryn M Edwards; Roger J Lewis; Jens D Lundgren; Charles D Wells; Fred Wabwire-Mangen; Keith P W J McAdam
Journal:  Clin Infect Dis       Date:  2018-04-17       Impact factor: 9.079

5.  A multi-source adaptive platform design for testing sequential combinatorial therapeutic strategies.

Authors:  Alexander M Kaizer; Brian P Hobbs; Joseph S Koopmeiners
Journal:  Biometrics       Date:  2018-01-22       Impact factor: 2.571

6.  The Past Need Not Be Prologue: Recommendations for Testing and Positioning the Most-Promising Medical Countermeasures for the Next Outbreak of Ebola Virus Infection.

Authors:  Richard T Davey; Lori Dodd; Michael Proschan; Peter Jahrling; Lisa Hensley; Elizabeth Higgs; H Clifford Lane
Journal:  J Infect Dis       Date:  2018-11-22       Impact factor: 5.226

7.  Conducting clinical trials in outbreak settings: Points to consider.

Authors:  H Clifford Lane; Hilary D Marston; Anthony S Fauci
Journal:  Clin Trials       Date:  2016-01-14       Impact factor: 2.486

8.  GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic.

Authors:  John Whitehead; Peter Horby
Journal:  PLoS Negl Trop Dis       Date:  2017-03-09

9.  Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treatment of Ebola virus disease in Guinea during the 2014-2015 outbreak.

Authors:  Tansy Edwards; Malcolm G Semple; Anja De Weggheleire; Yves Claeys; Maaike De Crop; Joris Menten; Raffaella Ravinetto; Sarah Temmerman; Lutgarde Lynen; Elhadj Ibrahima Bah; Peter G Smith; Johan van Griensven
Journal:  Clin Trials       Date:  2016-01-14       Impact factor: 2.486

10.  Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.

Authors:  Nigel Stallard; Lisa Hampson; Norbert Benda; Werner Brannath; Thomas Burnett; Tim Friede; Peter K Kimani; Franz Koenig; Johannes Krisam; Pavel Mozgunov; Martin Posch; James Wason; Gernot Wassmer; John Whitehead; S Faye Williamson; Sarah Zohar; Thomas Jaki
Journal:  Stat Biopharm Res       Date:  2020-07-29       Impact factor: 1.452
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