DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and niologic license applications, 2006-2010. Value Health. 2012 May 1;15(3):443-8.
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
Mordin M, Clark M, DeMuro C, Evans ED, Copley-Merriman K, Fehnel S, Gnanasakthy A. Pro label claims: an analysis based on a review of pros among new molecular entities and biologic license applications 2006-2010. Poster presented at the 2011 ISPOR 16th Annual International Meeting; June 3, 2011. [abstract] Value Health. 2011 May; 14(3):A29.
DeMuro C, Mordin M, Evans ED, Copley-Merriman K, Fehnel S, Gnanasakthy A. Reasons for rejection of PRO label claims: an analysis based on a review of PRO use among new molecular entities and biologic license applications 2006–2010. Poster presented at the 2011 ISPOR 16th Annual International Meeting; June 3, 2011. [abstract] Value Health. 2011 May; 14(3):A29.
Mordin MM, Lewis SA, Gnanasakthy A, DeMuro-Mercon CJ, Copley-Merriman K, Fehnel SE. Patient-reported outcomes in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 1, 2010. Atlanta, GA. [abstract] Value Health. 2010 May; 13(3):A-17-8.
Mordin M, Lewis SE, Gnanasakthy A, DeMuro-Mercon C, Copley-Merriman K, Fehnel S. Patient-reported outcomes as mentioned in product development guidance. Poster presented at the 2010 ISPOR 15th Annual International Meeting; May 4, 2010. [abstract] Value Health. 2010 May; 13(3):A17-8.
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