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
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.
Poole WK, Pollack M, Rapoport I, Williams V, Koch MA, Rao AV, Bartel DA. Use of Multivariate Methods in Quantifying the Variability in the Perception of Neonatal Intensive Care Unit Characteristics in Nine Hospitals in the Washington, DC Area: the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia. Interstat. 2002 Jan 1.