Literature DB >> 32242365

Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.

Natalie E Dean1, Pierre-Stéphane Gsell1, Ron Brookmeyer1, Forrest W Crawford1, Christl A Donnelly1, Susan S Ellenberg1, Thomas R Fleming1, M Elizabeth Halloran1, Peter Horby1, Thomas Jaki1, Philip R Krause1, Ira M Longini1, Sabue Mulangu1, Jean-Jacques Muyembe-Tamfum1, Martha C Nason1, Peter G Smith1, Rui Wang1, Ana M Henao-Restrepo1, Victor De Gruttola1.   

Abstract

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Year:  2020        PMID: 32242365      PMCID: PMC7490833          DOI: 10.1056/NEJMsb1905390

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   176.079


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  13 in total

Review 1.  Issues in data monitoring and interim analysis of trials.

Authors:  A M Grant; D G Altman; A B Babiker; M K Campbell; F J Clemens; J H Darbyshire; D R Elbourne; S K McLeer; M K B Parmar; S J Pocock; D J Spiegelhalter; M R Sydes; A E Walker; S A Wallace
Journal:  Health Technol Assess       Date:  2005-03       Impact factor: 4.014

Review 2.  The alpha spending function approach to interim data analyses.

Authors:  D L DeMets; G Lan
Journal:  Cancer Treat Res       Date:  1995

3.  Protective efficacy of a live attenuated vaccine against Argentine hemorrhagic fever. AHF Study Group.

Authors:  J I Maiztegui; K T McKee; J G Barrera Oro; L H Harrison; P H Gibbs; M R Feuillade; D A Enria; A M Briggiler; S C Levis; A M Ambrosio; N A Halsey; C J Peters
Journal:  J Infect Dis       Date:  1998-02       Impact factor: 5.226

4.  A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.

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

5.  A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.

Authors:  Sabue Mulangu; Lori E Dodd; Richard T Davey; Olivier Tshiani Mbaya; Michael Proschan; Daniel Mukadi; Mariano Lusakibanza Manzo; Didier Nzolo; Antoine Tshomba Oloma; Augustin Ibanda; Rosine Ali; Sinaré Coulibaly; Adam C Levine; Rebecca Grais; Janet Diaz; H Clifford Lane; Jean-Jacques Muyembe-Tamfum; Billy Sivahera; Modet Camara; Richard Kojan; Robert Walker; Bonnie Dighero-Kemp; Huyen Cao; Philippe Mukumbayi; Placide Mbala-Kingebeni; Steve Ahuka; Sarah Albert; Tyler Bonnett; Ian Crozier; Michael Duvenhage; Calvin Proffitt; Marc Teitelbaum; Thomas Moench; Jamila Aboulhab; Kevin Barrett; Kelly Cahill; Katherine Cone; Risa Eckes; Lisa Hensley; Betsey Herpin; Elizabeth Higgs; Julie Ledgerwood; Jerome Pierson; Mary Smolskis; Ydrissa Sow; John Tierney; Sumathi Sivapalasingam; Wendy Holman; Nikki Gettinger; David Vallée; Jacqueline Nordwall
Journal:  N Engl J Med       Date:  2019-11-27       Impact factor: 91.245

6.  Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both.

Authors:  Janet Woodcock; Lisa M LaVange
Journal:  N Engl J Med       Date:  2017-07-06       Impact factor: 91.245

Review 7.  Lassa fever.

Authors:  Catherine Houlihan; Ron Behrens
Journal:  BMJ       Date:  2017-07-12

8.  Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.

Authors:  Stephen B Kennedy; James D Neaton; H Clifford Lane; Mark W S Kieh; Moses B F Massaquoi; Nancy A Touchette; Martha C Nason; Dean A Follmann; Fatorma K Boley; Melvin P Johnson; Gregg Larson; Francis N Kateh; Tolbert G Nyenswah
Journal:  Clin Trials       Date:  2016-01-14       Impact factor: 2.486

9.  Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group.

Authors:  A C Steere; V K Sikand; F Meurice; D L Parenti; E Fikrig; R T Schoen; J Nowakowski; C H Schmid; S Laukamp; C Buscarino; D S Krause
Journal:  N Engl J Med       Date:  1998-07-23       Impact factor: 91.245

10.  WHO R&D Blueprint: a global coordination mechanism for R&D preparedness.

Authors:  Marie Paule Kieny; Peter Salama
Journal:  Lancet       Date:  2017-06-24       Impact factor: 79.321

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  26 in total

1.  Opinion: A risk-benefit framework for human research during the COVID-19 pandemic.

Authors:  Julie C Lumeng; Tabbye M Chavous; Anna S Lok; Srijan Sen; Nicholas S Wigginton; Rebecca M Cunningham
Journal:  Proc Natl Acad Sci U S A       Date:  2020-10-21       Impact factor: 11.205

2.  Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Authors:  Renato D Lopes; Ariane Vieira Scarlatelli Macedo; Pedro Gabriel Melo de Barros E Silva; Renata Junqueira Moll-Bernardes; Andre Feldman; Guilherme D'Andréa Saba Arruda; Andrea Silvestre de Souza; Denilson Campos de Albuquerque; Lilian Mazza; Mayara Fraga Santos; Natalia Zerbinatti Salvador; C Michael Gibson; Christopher B Granger; John H Alexander; Olga Ferreira de Souza
Journal:  Am Heart J       Date:  2020-05-13       Impact factor: 4.749

3.  Generating evidence for therapeutic effects: the need for well-conducted randomized trials.

Authors:  Robert M Califf; Lesley H Curtis; Robert A Harrington; Adrian F Hernandez; Eric D Peterson
Journal:  J Clin Invest       Date:  2021-01-19       Impact factor: 14.808

4.  Clinical trials in a COVID-19 pandemic: Shared infrastructure for continuous learning in a rapidly changing landscape.

Authors:  Haley Hedlin; Ariadna Garcia; Yingjie Weng; Ziyuan He; Vandana Sundaram; Bryan Bunning; Vidhya Balasubramanian; Kristen Cunanan; Kristopher Kapphahn; Santosh Gummidipundi; Natasha Purington; Mary Boulos; Manisha Desai
Journal:  Clin Trials       Date:  2021-02-03       Impact factor: 2.486

5.  Commentary on the role of statisticians in pandemics.

Authors:  Ron Brookmeyer
Journal:  Stat Med       Date:  2021-05-20       Impact factor: 2.373

6.  Analysis of clinical and methodological characteristics of early COVID-19 treatment clinical trials: so much work, so many lost opportunities.

Authors:  Beatrice Mainoli; Tiago Machado; Gonçalo S Duarte; Luísa Prada; Nilza Gonçalves; Joaquim J Ferreira; João Costa
Journal:  BMC Med Res Methodol       Date:  2021-02-26       Impact factor: 4.615

7.  What do we do with our under-enrolled single-center COVID-19 clinical trials?

Authors:  Shing M Lee; Denise Esserman; Ken Cheung; James Dziura; Peter Peduzzi; Magdalena Sobieszczyk
Journal:  Clin Trials       Date:  2021-07-03       Impact factor: 2.599

8.  Trials and tribulations: so many potential treatments, so few answers.

Authors:  Aaron Gazendam; Nicholas Nucci; Seper Ekhtiari; Chetan Gohal; Meng Zhu; Abbey Payne; Mohit Bhandari
Journal:  Int Orthop       Date:  2020-05-24       Impact factor: 3.075

9.  Aggregating data from COVID-19 trials.

Authors:  Elizabeth L Ogburn; Barbara E Bierer; Ron Brookmeyer; Christine Choirat; Natalie E Dean; Victor De Gruttola; Susan S Ellenberg; M Elizabeth Halloran; Daniel F Hanley; Joseph K Lee; Rui Wang; Daniel O Scharfstein
Journal:  Science       Date:  2020-06-12       Impact factor: 47.728

10.  Promoting Better Clinical Trials and Drug Information as Public Health Interventions for the COVID-19 Emergency in Italy.

Authors:  Antonio Addis; Armando Genazzani; Maria Paola Trotta; Nicola Magrini
Journal:  Ann Intern Med       Date:  2020-06-16       Impact factor: 25.391

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