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
Hansen MK, Gammelager H, Jacobsen CJ, Hjortdal VE, Layton JB, Rasmussen BS, Andreasen JJ, Johnsen SP, Christiansen CF. Acute kidney injury and long-term risk of cardiovascular events after cardiac surgery: a population-based cohort study. J Cardiothorac Vasc Anesth. 2015 Jun;29(3):617-25. doi: 10.1053/j.jvca.2014.08.020
Tennis P, Chan KA, Curkendall SN, Li DK, Mines D, Peterson C, Andrews EB, Calingaert B, Chen HY, Deshpande G, Everage N, Holick CN, Meyer NM, Nkhoma ET, Quinn S, Rothman KJ, Esposito DB. Topiramate use during pregnancy and major congenital malformations in multiple populations. Birth Defects Res Part A Clin Mol Teratol. 2015 Apr;103(4):269-75. doi: 10.1002/bdra.23357.
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.