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, 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, 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.
Mordin MM, Clark M, Siersma CA, Copley-Merriman K, Gnanasakthy A. Impact of the FDA draft guidance on patient reported outcomes (PRO) label claims for approved drug products in the US: has it made a difference? Poster presented at the International Society for Pharmacoeconomics and Outcomes Research 14th Annual International Meeting; May 19, 2009. Orlando, FL. [abstract] Value Health. 2009 May; 12(3):A29.
Clark MJ. Obtaining a patient reported outcome label claim: what is it, how do you achieve it, and why is it helpful for a pharmaceutical company? Presented at the Patient Reported Outcomes graduate course at the University of Michigan College of Pharmacy; March 1, 2009.
Shah S, Sesti AM, Copley-Merriman K, Plante M. Quality of life terminology included in package inserts for US approved medications. Qual Life Res. 2003 Dec 1;12(8):1107-17.
Clark MJ. Opportunities for pharmacists in industry: outcomes research. Presented at the International Society for Pharmacoeconomics and Outcomes Research UM Student Chapter; March 2003.