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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: luedtke a. 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.
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: luedtke a. 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.
A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated.
Follmann D, Fintzi J, Fay MP, Janes HE, Baden LR, El Sahly HM, 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: luedtke a. Ann Intern Med. 2021 Aug;174(8):1118-1125. doi: 10.7326/M20-8149. Epub 2021 Apr 13. Ann Intern Med. 2021. PMID: 33844575 Free PMC article.
Study design approaches for future active-controlled HIV prevention trials.
Donnell D, Kansiime S, Glidden DV, Luedtke A, Gilbert PB, Gao F, Janes H. Donnell D, et al. Among authors: luedtke a. Stat Commun Infect Dis. 2024 Jan 22;15(1):20230002. doi: 10.1515/scid-2023-0002. eCollection 2024 Jan. Stat Commun Infect Dis. 2024. PMID: 38250627 Free PMC article.
Evaluating the impact of treating the optimal subgroup.
Luedtke AR, van der Laan MJ. Luedtke AR, et al. Stat Methods Med Res. 2017 Aug;26(4):1630-1640. doi: 10.1177/0962280217708664. Epub 2017 May 8. Stat Methods Med Res. 2017. PMID: 28482779 Free PMC article.
104 results