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
Earnshaw SR, Kauf TL, McDade C, Potashman MH, Pauyo C, Reese ES, Senagore A. Economic impact of alvimopan considering varying definitions of postoperative ileus. J Am Coll Surg. 2015 Nov;221(5):941-50. doi: 10.1016/j.jamcollsurg.2015.08.004
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.
Inabnet WB3rd, Winegar DA, Sherif BN, Sarr MG. Early outcomes of bariatric surgery in patients with metabolic syndrome: an analysis of the bariatric outcomes longitudinal database. J Am Coll Surg. 2012 Apr;214(4):550-6.