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Data and Safety Monitoring of COVID-19 Vaccine Clinical Trials.
Joffe S, Babiker A, Ellenberg SS, Fix A, Griffin MR, Hunsberger S, Kalil J, Levine MM, Makgoba MW, Moore RH, Tsiatis AA, Whitley R. Joffe S, et al. Among authors: ellenberg ss. J Infect Dis. 2021 Dec 15;224(12):1995-2000. doi: 10.1093/infdis/jiab263. J Infect Dis. 2021. PMID: 34008027 Free PMC article. Review.
Commentary on Hey and Kimmelman.
Joffe S, Ellenberg SS. Joffe S, et al. Among authors: ellenberg ss. Clin Trials. 2015 Apr;12(2):116-8. doi: 10.1177/1740774515568917. Epub 2015 Feb 3. Clin Trials. 2015. PMID: 25649113 No abstract available.
Rigorous Clinical Trial Design in Public Health Emergencies Is Essential.
Ellenberg SS, Keusch GT, Babiker AG, Edwards KM, Lewis RJ, Lundgren JD, Wells CD, Wabwire-Mangen F, McAdam KPWJ. Ellenberg SS, et al. Clin Infect Dis. 2018 Apr 17;66(9):1467-1469. doi: 10.1093/cid/cix1032. Clin Infect Dis. 2018. PMID: 29177461 Free PMC article.
Reply to Jacob and Colebunders.
Ellenberg SS, Keusch GT, Babiker AG, Edwards KM, Lewis RJ, Lundgren JD, Wells CD, Wabwire-Mangen F, McAdam KPWJ. Ellenberg SS, et al. Clin Infect Dis. 2018 Aug 31;67(6):985-986. doi: 10.1093/cid/ciy250. Clin Infect Dis. 2018. PMID: 29590323 No abstract available.
Clinical trials in the time of a pandemic.
Ellenberg SS. Ellenberg SS. Clin Trials. 2020 Oct;17(5):467-471. doi: 10.1177/1740774520939871. Epub 2020 Jul 10. Clin Trials. 2020. PMID: 32650672 Review.
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: ellenberg ss. 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.
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.
Dunkle LM, Kotloff KL, Gay CL, Áñez G, Adelglass JM, Barrat Hernández AQ, Harper WL, Duncanson DM, McArthur MA, Florescu DF, McClelland RS, Garcia-Fragoso V, Riesenberg RA, Musante DB, Fried DL, Safirstein BE, McKenzie M, Jeanfreau RJ, Kingsley JK, Henderson JA, Lane DC, Ruíz-Palacios GM, Corey L, Neuzil KM, Coombs RW, Greninger AL, Hutter J, Ake JA, Smith K, Woo W, Cho I, Glenn GM, Dubovsky F; 2019nCoV-301 Study Group. Dunkle LM, et al. N Engl J Med. 2022 Feb 10;386(6):531-543. doi: 10.1056/NEJMoa2116185. Epub 2021 Dec 15. N Engl J Med. 2022. PMID: 34910859 Free PMC article. Clinical Trial.
221 results