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Adaptive methods: telling "the rest of the story".
Emerson SS, Fleming TR. Emerson SS, et al. Among authors: fleming tr. J Biopharm Stat. 2010 Nov;20(6):1150-65. doi: 10.1080/10543406.2010.514457. J Biopharm Stat. 2010. PMID: 21058111
Response.
Fleming TR. Fleming TR. Clin Trials. 2015 Feb;12(1):21-3. doi: 10.1177/1740774514563356. Clin Trials. 2015. PMID: 25721147 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.
Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks.
Dean NE, Gsell PS, Brookmeyer R, Crawford FW, Donnelly CA, Ellenberg SS, Fleming TR, Halloran ME, Horby P, Jaki T, Krause PR, Longini IM, Mulangu S, Muyembe-Tamfum JJ, Nason MC, Smith PG, Wang R, Henao-Restrepo AM, De Gruttola V. Dean NE, et al. Among authors: fleming tr. N Engl J Med. 2020 Apr 2;382(14):1366-1369. doi: 10.1056/NEJMsb1905390. N Engl J Med. 2020. PMID: 32242365 Free PMC article. No abstract available.
Placebo-Controlled Trials of Covid-19 Vaccines - Why We Still Need Them.
WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation; Krause PR, Fleming TR, Longini IM, Peto R, Beral V, Bhargava B, Cravioto A, Cramer JP, Ellenberg SS, Figueroa JP, Halloran E, Henao-Restrepo AM, Ryan MJ, Levine MM, Nason M, Nohynek HM, Plotkin S, Rees H, Singh JA, Swaminathan S. WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation, et al. Among authors: fleming tr. N Engl J Med. 2021 Jan 14;384(2):e2. doi: 10.1056/NEJMp2033538. Epub 2020 Dec 2. N Engl J Med. 2021. PMID: 33264543 No abstract available.
SARS-CoV-2 Variants and Vaccines.
Krause PR, Fleming TR, Longini IM, Peto R, Briand S, Heymann DL, Beral V, Snape MD, Rees H, Ropero AM, Balicer RD, Cramer JP, Muñoz-Fontela C, Gruber M, Gaspar R, Singh JA, Subbarao K, Van Kerkhove MD, Swaminathan S, Ryan MJ, Henao-Restrepo AM. Krause PR, et al. Among authors: fleming tr. N Engl J Med. 2021 Jul 8;385(2):179-186. doi: 10.1056/NEJMsr2105280. Epub 2021 Jun 23. N Engl J Med. 2021. PMID: 34161052 Free PMC article.
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.
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