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
Hillmen P, Xie J, Yong A, Waweru C, Sorof TA, Goyal RK, Davis KL. Real-world treatment patterns, adverse events and clinical outcomes in patients with chronic lymphocytic leukaemia treated with ibrutinib in the UK. EJHaem. 2021 May;2(2):219-27. doi: 10.1002/jha2.174
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
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.
Yates ME, Stellato RK, Johannes CB, Avis NE. The importance of AIDS-related knowledge for mid-life and older women. AIDS Educ Prev. 1999 Jun;11(3):224-31.
Williams VSL. The "unbiased" anchor: bridging the gap between DIF and item bias. Appl Meas Educ. 1997;10(3):253-67. doi: 10.1207/s15324818ame1003_4