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Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health.
Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H; CABP-ABSSSI Project Team. Talbot GH, et al. Among authors: fleming tr. Clin Infect Dis. 2012 Oct;55(8):1114-21. doi: 10.1093/cid/cis566. Epub 2012 Jun 28. Clin Infect Dis. 2012. PMID: 22744885 Free PMC article. Review.
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.
Mehrotra DV, Janes HE, Fleming TR, Annunziato PW, Neuzil KM, Carpp LN, Benkeser D, Brown ER, Carone M, Cho I, Donnell D, Fay MP, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Juraska M, Luedtke A, Nason M, Vandebosch A, Zhou H, Cohen MS, Corey L, Hartzel J, Follmann D, Gilbert PB. Mehrotra DV, et al. Among authors: fleming tr. Ann Intern Med. 2021 Feb;174(2):221-228. doi: 10.7326/M20-6169. Epub 2020 Oct 22. Ann Intern Med. 2021. PMID: 33090877 Free PMC article.
COVID-19 vaccine trials should seek worthwhile efficacy.
Krause P, Fleming TR, Longini I, Henao-Restrepo AM, Peto R; World Health Organization Solidarity Vaccines Trial Expert Group. Krause P, et al. Among authors: fleming tr. Lancet. 2020 Sep 12;396(10253):741-743. doi: 10.1016/S0140-6736(20)31821-3. Epub 2020 Aug 27. Lancet. 2020. PMID: 32861315 Free PMC article. No abstract available.
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.
224 results