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Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.
Berger ML, Sox H, Willke RJ, Brixner DL, Eichler HG, Goettsch W, Madigan D, Makady A, Schneeweiss S, Tarricone R, Wang SV, Watkins J, Daniel Mullins C. Berger ML, et al. Among authors: makady a. Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1033-1039. doi: 10.1002/pds.4297. Pharmacoepidemiol Drug Saf. 2017. PMID: 28913966 Free PMC article.
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: makady a. 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.
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