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Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Eichler HG, Adams R, Andreassen E, Arlett P, van de Casteele M, Chapman SJ, Goettsch WG, Martinsson JL, Llinares-Garcia J, Nachtnebel A, Pean E, Rasi G, Reksten TR, Timmers L, Vreman RA, van de Vijver I, Wenzl M. Eichler HG, et al. Among authors: arlett p. Int J Technol Assess Health Care. 2021 Aug 23;37(1):e83. doi: 10.1017/S026646232100057X. Int J Technol Assess Health Care. 2021. PMID: 34424152
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
Eichler HG, Pignatti F, Schwarzer-Daum B, Hidalgo-Simon A, Eichler I, Arlett P, Humphreys A, Vamvakas S, Brun N, Rasi G. Eichler HG, et al. Among authors: arlett p. Clin Pharmacol Ther. 2021 May;109(5):1212-1218. doi: 10.1002/cpt.2083. Epub 2020 Nov 12. Clin Pharmacol Ther. 2021. PMID: 33063841 Free PMC article. Review.
Graphical Depiction of Longitudinal Study Designs in Health Care Databases.
Schneeweiss S, Rassen JA, Brown JS, Rothman KJ, Happe L, Arlett P, Dal Pan G, Goettsch W, Murk W, Wang SV. Schneeweiss S, et al. Among authors: arlett p. Ann Intern Med. 2019 Mar 19;170(6):398-406. doi: 10.7326/M18-3079. Epub 2019 Mar 12. Ann Intern Med. 2019. PMID: 30856654
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Moseley J, Vamvakas S, Berntgen M, Cave A, Kurz X, Arlett P, Acha V, Bennett S, Cohet C, Corriol-Rohou S, Du Four E, Lamoril C, Langeneckert A, Koban M, Pasté M, Sandler S, Van Baelen K, Cangini A, García S, Obach M, Gimenez Garcia E, Varela Lema L, Jauhonen HM, Rannanheimo P, Morrison D, Van De Casteele M, Strömgren A, Viberg A, Makady A, Guilhaume C. Moseley J, et al. Among authors: arlett p. Br J Clin Pharmacol. 2020 Jun;86(6):1034-1051. doi: 10.1111/bcp.14279. Epub 2020 Apr 24. Br J Clin Pharmacol. 2020. PMID: 32162368 Free PMC article. Review.
65 results