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
Ko DT, Khan AM, Kotrri G, Austin PC, Wijeysundera HC, Koh M, Chu A, Jackevicius CA, Lawler PR, Tu JV. Eligibility, clinical outcomes, and budget impact of PCSK9 inhibitor adoption: the CANHEART PCSK9 study. J Am Heart Assoc. 2018 Nov 6;7(21):e010007. doi: 10.1161/JAHA.118.010007
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.
Patorno E, Glynn RJ, Hernandez-Diaz S, Avorn J, Wahl PM, Bohn RL, Mines D, Liu J, Schneeweiss S. Risk of ischemic cerebrovascular and coronary events in adult users of anticonvulsant medications in routine care settings. J Am Heart Assoc. 2013 Jul 30;2(4):e000208. doi: 10.1161/JAHA.113.000208.
Lang K, Meyers JL, Korn JR, Lee S, Sikirica M, Crivera C, Dirani R, Menzin J. Medication adherence and hospitalization among patients with schizophrenia treated with antipsychotics. Psychiatr Serv. 2010 Dec 1;61(12):1239-47.