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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.
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.
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.
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.
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.
Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden L, Sahly HE, Fleming TR, Mehrotra DV, Carpp LN, Juraska M, Benkeser D, Donnell D, Fong Y, Han S, Hirsch I, Huang Y, Huang Y, Hyrien O, Luedtke A, Carone M, Nason M, Vandebosch A, Zhou H, Cho I, Gabriel E, Kublin JG, Cohen MS, Corey L, Gilbert PB, Neuzil KM. Follmann D, et al. Among authors: fleming tr. medRxiv [Preprint]. 2020 Dec 14:2020.12.14.20248137. doi: 10.1101/2020.12.14.20248137. medRxiv. 2020. PMID: 33336213 Free PMC article. Updated. Preprint.
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