Publications

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Displaying 1 through 10 of 10 publications.

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

Gnanasakthy A, Russo J, Gnanasakthy K, Harris N, Castro C. A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018). Contemp Clin Trials. 2022 Sep;120:106860. doi: 10.1016/j.cct.2022.106860

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

Ling W, Nadipelli VR, Ronquest N, Albright VA, Aldridge AP, Learned SM, Mehra V, Heidbreder C. Remission from chronic opioid use-studying environmental and socio-economic factors on recovery (RECOVER): study design and participant characteristics. Contemp Clin Trials. 2019 Jan;76:93-103. doi: 10.1016/j.cct.2018.11.015

Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials. 2015 Apr 18;43:1-9. doi: 10.1016/j.cct.2015.04.004

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.

Davis AE, Mehrotra S, Friedewald J, Ladner D. Characteristics of a simulation model of the national kidney transplantation system. Poster presented at the 2013 Winter Simulation Conference: Simulation: Making Decisions in a Complex World; December 2013. [abstract] Ieee/Acm Trans Comput Biol Bioinform. 2013 Dec; p.2320-9.

Gnanasakthy A, DeMuro C, Boulton C. Integration of patient-reported outcomes in multiregional confirmatory clinical trials. Contemp Clin Trials. 2013 May 1;35(1):62-9.

Hareendran A, Gnanasakthy A, Winnette RM, Revicki D. Capturing patients' perspectives of treatment in clinical trials/drug development. Contemp Clin Trials. 2012 Jan;33(1):23-8.

Stull DE, Wiklund I, Gale R, Capkun-Niggli G, Houghton K, Jones P. Application of latent growth and growth mixture modeling to identify and characterize differential responders to treatment for COPD. Contemp Clin Trials. 2011 Nov 1;32(6):818-28.