Bent R, Carson RT, Gnanasakthy A, Kennedy A. Multi-stakeholder perspectives on the patient experience data summary section in new product approvals: current state & future considerations. Presented at the 2020 ISPOR Virtual Conference; May 20, 2020.
Byrom B, Gwaltney C, Slagle A, Gnanasakthy A, Muehlhausen W. Measurement equivalence of patient-reported outcome measures migrated to electronic formats: a review of evidence and recommendations for clinical trials and bring your own device. Expert commentary. Ther Innov Regul Sci. 2018 Aug 29. doi: 10.1177/2168479018793369
Gnanasakthy A, Basch E. Assessment of patient-reported outcomes in industry-sponsored clinical trials. In: Kelly WK, Halabi S, editors. Oncology clinical trials: successful design, conduct, and analysis. Second Edition ed. New York: NY. Demos Medical Publishing; 2018.
Gnanasakthy A. Strategies for including patient-reported outcomes in research. Presented at the 2017 ASCO Annual Meeting; June 3, 2017. Chicago, IL.
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. A review of FDA PRO labeling. Presented at the Seventh Annual Patient-Reported Outcome Consortium Workshop; April 27, 2016. Silver Spring, MD.
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
O'Donohoe P, Lundy JJ, Gnanasakthy A, Greene A. Considerations for requiring subjects to provide a response to electronic patient-reported outcome instruments. Ther Innov Regul Sci. 2015 Nov;49(6):792-6. doi: 10.1177/2168479015609647
Gnanasakthy A, Doward L, Bal V, Fricke FU. How to bring PRO data into payer decision making: PRO strategies in pharmaceutical development. Presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy.
Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins J, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: evidence from clinicaltrials.gov (2007-2013). Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.
Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials. 2015 Apr 18;43:1-9. doi: 10.1016/j.cct.2015.04.004
Gnanasakthy A, DeMuro-Mercon CJ. Logistical considerations for intergrating patient-reported outcomes in multiregional clinical trials. Clinical Researcher. 2015 Apr;45-8.
Rothman M, Gnanasakthy A, Wicks P, Papadopoulos EJ. Can we use social media to support content validity of patient-reported outcome instruments in medical product development? Value Health. 2015 Jan;18(1):1-4. doi: 10.1016/j.jval.2014.10.001
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.
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.
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
Hareendran A, Gnanasakthy A, Winnette RM, Revicki D. Capturing patients' perspectives of treatment in clinical trials/drug development. Contemp Clin Trials. 2012 Jan;33(1):23-8.
Baldwin M, Spong A, Doward LC, Gnanasakthy A. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond. Patient. 2011 Jan;4(1):11-7. doi: 10.2165
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
Doward LC, Gnanasakthy A, Baker MG. Patient reported outcomes: looking beyond the label claim. Health Qual Life Outcomes. 2010;8(89).
Revicki DA, Gnanasakthy A, Weinfurt K. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO evidence dossier. Qual Life Res. 2007 May;16(4):717-23.
Backhouse ME, Gnanasakthy A, Schulman KA, Akehurst R, Glick H. The development of standard economic datasets for use in the economic evaluation of medicines. Drug Inf J. 2000;34(4):1273-91.