Carrigan G, Bradbury BD, Brookhart MA, Capra WB, Chia V, Rothman KJ, Sarsour K, Taylor MD, Brown JS. External comparator groups derived from real-world data used in support of regulatory decision making: use cases and challenges. Curr Epidemiol Rep. 2022 Dec;9:326-37. doi: 10.1007/s40471-022-00305-9
Margulis AV, Anthony M, Rivero-Ferrer E. Drug safety in pregnancy: review of study approaches requested by regulatory agencies. Curr Epidemiol Rep. 2019 Sep;6(3):380-9. doi: 10.1007/s40471-019-00212-6
Lin HM, Davis KL, Kaye JA, Luptakova K, Nagar SP, Mohty M. Real-world treatment patterns, outcomes, and healthcare resource utilization in relapsed or refractory multiple myeloma: evidence from a medical record review in France. Adv Hematol. 2019 Jan 29;2019(4625787). doi: 10.1155/2019/4625787
Davis KL, Cote I, Kaye JA, Mendelson E, Gao H, Perez Ronco J. Real-world assessment of clinical outcomes in patients with lower-risk myelofibrosis receiving treatment with ruxolitinib. Adv Hematol. 2015 Oct;2015(2015):848473. doi: 10.1155/2015/848473
Andrews EB, Margulis AV, Tennis PS, West SL. Opportunities and challenges in using epidemiologic methods to monitor drug safety in the era of large automated health databases. Curr Epidemiol Rep. 2014 Oct 12;1(4):194-205.