Cella D, Wen PY, Ervin C, Vallow S, Gilloteau I, DeMuro C, Mordin M, Agostinho AC, Dine J. Understanding the patient experience and treatment benefits in patients with non–small-cell lung cancer with brain metastasis. Cancer Med. 2023 Jun 12;12(12):13637-48. doi: 10.1002/cam4.5975
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.
Mordin M, Brown TM, McLeod L, DeMuro C, Gnanasakthy A. Two companies following the FDA pro guidance leads to similar but different measures: a case study in psoriasis. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.
DeMuro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value Health. 2013 Dec;16(8):1150-5. doi: 10.1016/j.jval.2013.08.2293
Gnanasakthy A, Lewis S, Clark M, Mordin M, DeMuro C. Potential of patient-reported outcomes as nonprimary endpoints in clinical trials. Health Qual Life Outcomes. 2013 May 15;11:83.
Gnanasakthy A, DeMuro-Mercon CJ, Clark MJ, Mordin MM, Thomas S. Role of patient-reported outcome measures in the assessment of central nervous system agents. Ther Innov Regul Sci. 2013;47(5):613-8.
Gnanasakthy A, Doward L, Clark M, Mordin M, DeMuro C. Concordance of pro labeling claims between the FDA and EMA. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 9, 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A321.
Engelhart L, Nelson L, Lewis S, Mordin M, Demuro-Mercon C, Uddin S, McLeod L, Cole B, Farr J. Knee injury and osteoarthritis outcome score subscales for patients with articular cartilage lesions of the knee. Am J Sports Med. 2012 Oct 1;40(10):2264-72.
Gnanasakthy A, Lewis SA, Clark MJ, Mordin MM, Evans E, DeMuro-Mercon CJ. The impact of primary endpoints on patient-reported outcome label claims. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012.
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, 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.
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.
Lewis SA, DeMuro-Mercon CJ, Mordin MM, Farr J, Cole BJ, Mithoefer K, Engelhart L. Measuring pain and function in patients with articular cartilage repair. Poster presented at the 9th World Congress of the International Cartilage Repair Society; September 2010.
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