DiBenedetti DB, Brown TM, DeMuro CJ, Ervin C, Lewis SA, Fehnel SE. Conducting patient interviews within a clinical trial setting. RTI Press. 2018 Aug. doi: 10.3768/rtipress.2018.op.0054.1808
Lewis S, DeMuro C. Use of exit interviews with participants in randomized controlled trials: value of understanding the patient experience. Poster presented at the 9th Annual SCOPE Summit Conference; February 14, 2018. Orlando, FL.
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.
Winnette R, Zárate V, Machnicki G, Demuro-Mercon C, Gawlicki M, Gnanasakthy A. Patient-reported outcomes in Latin America: implementation in research and role in emerging HTA systems. Value in Health Regional Issues. 2015 Dec;8:49-55. doi: 10.1016/j.vhri.2015.03.008
Hogue S, Brogan AP, DeMuro C, Barrett A, D'Alessio D, Bal V. Influence of patient-reported outcomes on market access decisions in decentralized markets (Brazil, Italy, Spain, and the United States). Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA. [abstract] Value Health. 2015 May; 18(3):A212.
Gnanasakthy A, DeMuro-Mercon CJ. Logistical considerations for intergrating patient-reported outcomes in multiregional clinical trials. Clinical Researcher. 2015 Apr;45-8.
Gnanasakthy A, Sadrick A, Eghbal-Ahmadi M, DeMuro C. Promotion of patient-reported outcome label claims based on nonprimary endpoints. Ther Innov Regul Sci. 2014 Sep;48(5):557-63.
Clark MJ, Simons C, Haydysch EE, DeMuro-Mercon CJ, Gnanasakthy A. A review of patient-reported outcome orphan drug labels in the United States from January 2006-September 2013: analysis of evidence for orphan drug PRO label claims. Poster presented at the 2014 ISPOR 19th Annual International Meeting; June 3, 2014.
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 C, Boulton C. Integration of patient-reported outcomes in multiregional confirmatory clinical trials. Contemp Clin Trials. 2013 May 1;35(1):62-9.
Fehnel S, DeMuro C, McLeod L, Coon C, Gnanasakthy A. FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev Pharmacoecon Outcomes Res. 2013;13(4):441-6.
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.
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, 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.
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
DeMuro CJ, Lewis SA, DiBenedetti DB, Price MA, Fehnel SE. Successful implementation of cognitive interviews in special populations. Expert Rev Pharmacoecon Outcomes Res. 2012 Apr 1;12(2):181-7.
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.
Norquist JM, Girman CJ, Fehnel S, DeMuro C, Santanello N. Choice of recall period for patient-reported outcome measures: criteria for consideration. Poster presented at the International Society for Quality of Life Research (ISOQOL) 2010 Annual Meeting; November 18, 2010.
DeMuro-Mercon CJ, DiBenedetti DB, Lewis SA, Fehnel SE. Successful implementation of the cognitive interviews in special populations. Presented at the 17th Annual Conference of the International Society for Quality of Life Research; November 1, 2010. Previously presented at the 16th Annual Conference of the International Society for Quality of Life Research.
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
DeMuro-Mercon CJ, DiBenedetti DB, Lewis SA, Fehnel SE. Successful implementation of the cognitive interview in special populations. Presented at the 16th Annual Conference of the International Society for Quality of Life Research; October 1, 2009.
Williams VS, DeMuro-Mercon CJ, Reeve BB, Erder MH. Implementing FDA PRO Guidelines: content validity and good measurement practices — what is the right balance? Presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting; May 15, 2009. Orlando, FL.
DeMuro-Mercon CJ, Lewis SA, Pearson JD. E-pro's: one size does not fit all critical factors in making it work. Presented at the CBINet Conference; July 2005.
DeMuro-Mercon CJ, Gonce C, Lewis SA, Altarac D, O'Keefe S, Bachmann S. The electronic patient reported outcome (e-PRO): compliance procedures and regulatory applicability. Poster presented at the Drug Information Association; October 2003.
DeMuro-Mercon CJ, Gonce C, Lewis SA. The electronic patient reported outcome (e-PRO) work for diary and questionnaire data. Presented at the Drug Information Association; 2003.
DeMuro-Mercon CJ, Lewis SA, Gonce C. Old relationships, new technologies: partnering with your clinical sites to make an electronic patient reported outcome (e-PRO) work for diary and questionnaire data. Poster presented at the Drug Information Association; 2003.