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A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats.
Longini IM, Yang Y, Fleming TR, Muñoz-Fontela C, Wang R, Ellenberg SS, Qian G, Halloran ME, Nason M, Gruttola V, Mulangu S, Huang Y, Donnelly CA, Henao Restrepo AM. Longini IM, et al. Among authors: fleming tr. Clin Trials. 2022 Dec;19(6):647-654. doi: 10.1177/17407745221110880. Epub 2022 Jul 22. Clin Trials. 2022. PMID: 35866633 Free PMC article. Clinical Trial.
Issues in regulatory guidelines for data monitoring committees.
DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R. DeMets D, et al. Clin Trials. 2004;1(2):162-9. doi: 10.1191/1740774504cn019xx. Clin Trials. 2004. PMID: 16281888 Review.
Bias and trials stopped early for benefit.
Ellenberg SS, DeMets DL, Fleming TR. Ellenberg SS, et al. Among authors: fleming tr. JAMA. 2010 Jul 14;304(2):158; author reply 158-9. doi: 10.1001/jama.2010.933. JAMA. 2010. PMID: 20628127 No abstract available.
Rejoinder.
Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TL, Pfeffer MA, Ellenberg SS. Fleming TR, et al. Clin Trials. 2017 Apr;14(2):126-127. doi: 10.1177/1740774516688917. Epub 2017 Jan 31. Clin Trials. 2017. PMID: 28135837 Free PMC article. No abstract available.
Data monitoring committees: Promoting best practices to address emerging challenges.
Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TL, Pfeffer MA, Ellenberg SS. Fleming TR, et al. Clin Trials. 2017 Apr;14(2):115-123. doi: 10.1177/1740774516688915. Epub 2017 Feb 1. Clin Trials. 2017. PMID: 28359194 Free PMC article.
Data Monitoring Committees: Current issues.
Fleming TR, Ellenberg SS, DeMets DL. Fleming TR, et al. Clin Trials. 2018 Aug;15(4):321-328. doi: 10.1177/1740774518764855. Epub 2018 Apr 9. Clin Trials. 2018. PMID: 29629815 Free PMC article.
225 results