Gnanasakthy A, Norcross L, (DeMuro) Romano C, Carson RT. A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health. 2022 Apr;25(4):647-55. doi: 10.1016/j.jval.2021.10.006
Gnanasakthy A, Barrett A, Norcross L, D’Alessio D, Romano (DeMuro) C. Use of patient and investigator global impression scales: a review of Food and Drug Administration–approved labeling, 2009 to 2019. Value Health. 2021 Jul;24(7):1016-23. doi: 10.1016/j.jval.2021.01.005
Gnanasakthy A, Barrett A, Evans E, D'Alessio D, Romano (DeMuro) C. A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012-2016). Value Health. 2019 Feb;22(2):203-9. doi: 10.1016/j.jval.2018.09.2842
DeMuro C, Gnanasakthy A, Price M, Winnette R, Desphande A. Development of a daily diary to assess signs and symptoms of genital herpes. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 22, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A80.
Gnanasakthy A, Mordin M, Evans E, Doward L, DeMuro C. A review of patient-reported outcome labeling in the United States (2011-2015). Value Health. 2017;20(3):420-9. doi: 10.1016/j.jval.2016.10.006
Gnanasakthy A, Mordin M, Haydysch E, DeMuro C. FDA patient-reported outcome labeling of novel therapies (2011-2015). Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 25, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A285-6.
Gnanasakthy A, DeMuro C. Outcome assessments of primary endpoints of new drugs approved by the FDA (2011-2015). Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 25, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A275.
DeMuro C, Clark M, Coon C, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO labels claims granted by the FDA as compared to the EMA. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A201. doi: 10.1016/j.jval.2012.03.1085
Gnanasakthy A, Sadrick A, DeMuro C, Rahul R. Promotion of patient reported outcomes (PRO) label claims based on non-primary endpoints. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A201. doi: 10.1016/j.jval.2012.03.1086
Gnanasakthy A, Lewis S, Clark M, Evans E, Mordin M, DeMuro C. Reported outcomes as primary endpoints in confirmatory clinical trials. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A200.
Gnanasakthy A, Mordin M, Clark M, DeMuro C, Fehnel S, Copley-Merriman C. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012 May;15(3):437-42. doi: 10.1016/j.jval.2011.11.032
Gnanasakthy A, DeMuro C, Mordin M, Copley-Merriman K, Mauskopf J. The role of the patient voice in health technology assessment. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A19. doi: 10.1016/S1098-3015(10)72074-X