Publications

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Displaying 51 through 100 of 115 publications.

DeMuro C, Gnanasakthy A, Price M, Winnette R, Desphande A. Development of a daily diary to assess signs and symptoms of genital herpes. Poster presented at the 2017 ISPOR 22nd Annual International Meeting; May 22, 2017. Boston, MA. [abstract] Value Health. 2017 May; 20(5):A80.

Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Impact of measuring patient-reported outcomes in dermatology drug development. Patient. 2017 Apr;10(2):203-13. doi: 10.1007/s40271-016-0196-6

Strober B, Gottlieb AB, Sherif B, Mollon P, Gilloteau I, McLeod L, Fox T, Mordin M, Gnanasakthy A, Papavassilis C, Lebwohl MG. Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. J Am Acad Dermatol. 2017 Apr;76(4):655-61. doi: 10.1016/j.jaad.2016.11.043

Gnanasakthy A, Hochhaus A, Giles FJ, Radich JP, Brandt P, Saglio G. ENESTfreedom trial of treatment-free remission: patient-reported quality of life before and after stopping treatment in patients with chronic myeloid leukemia in chronic phase. Poster presented at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27, 2017. Denver, CO. [abstract] J Manag Care Spec Pharm. 2017 Mar; 23(3a):S4.

Gnanasakthy A, Brandt P, Hughes TP. ENESTop trial of treatment-free remission: patient-reported quality of life before and after stopping treatment in patients with chronic myeloid leukemia in chronic phase. Poster presented at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27, 2017. Denver, CO. [abstract] J Manag Care Spec Pharm. 2017 Mar; 23(3a):S3.

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

Williams V, Coles T, Gnanasakthy A, DeMuro C, Yarr S, Williams NJ, Lowes L, Alfano L, Tseng B. Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis. Muscle Nerve. 2016 Oct 13;54(4):658-65. doi: 10.1002/mus.25080

DeMuro C, Lewis S, Lowes L, Alfano L, Tseng B, Gnanasakthy A. Development of the sporadic inclusion body myositis physical functioning assessment (sIFA). Muscle Nerve. 2016 Oct;54(4):653-7. doi: 10.1002/mus.25079

Gnanasakthy A, DeMuro C, Clark M, Haydysch E, Ma E, Bonthapally V. Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014). J Clin Oncol. 2016 Jun 1;34(16):1928-34. doi: 10.1200/JCO.2015.63.6480

Mordin M, Haydysch E, Graham-Clarke CP, Gnanasakthy A, Nikai E. Patient perceptions of psoriasis: a review of the survey literature by geography. Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 23, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A126-7.

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, DeMuro C. Outcome assessments of primary endpoints of new drugs approved by the FDA (2011-2015). Poster presented at the 2016 ISPOR 21st Annual International Meeting; May 25, 2016. Washington, DC. [abstract] Value Health. 2016 May; 19(3):A275.

Gnanasakthy A. A review of FDA PRO labeling. Presented at the Seventh Annual Patient-Reported Outcome Consortium Workshop; April 27, 2016. Silver Spring, MD.

Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nyirady J, Papavassils C, Nelson LM, McLeod LD, Mordin M, Gottlieb A, Elewski B, Lebwohl M. Psychometric validation of the psoriasis symptom diary using phase III study data from patients with chronic plaque psoriasis. Int J Dermatol. 2016 Mar;55(3):e147-55. doi: 10.1111/ijd.13117

Stull DE, McBride D, Houghton K, Finlay AY, Gnanasakthy A, Balp MM. Assessing changes in chronic spontaneous/idiopathic urticaria: comparisons of patient-reported outcomes using latent growth modeling. Adv Ther. 2016 Feb;33(2):214-24. doi: 10.1007/s12325-016-0282-0

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.

Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. Ther Innov Regul Sci. 2015 Oct;49(6):822-30. doi: 10.1177/2168479015608413

Bonthapally V, Ma E, Viviani S, Radford J, Brice P, von Tresckow B, Thomas E, Teasell J, Gnanasakthy A, Odom DM. Healthcare utilization in the AETHERA trial: phase 3 Study of brentuximab vedotin in patients at increased risk of residual hodgkin lymphoma post-ASCT. Poster presented at the 13th International Conference on Malignant Lymphoma (ICML); June 17, 2015. Lugano, Switzerland.

Bonthapally V, Ma E, Viviani S, Radford J, Brice P, von Tresckow B, Thomas E, Teasell J, Gnanasakthy A, Odom DM, Zhu Y, Lee S, Carlson P, Huebner D, Sweetenham J, Moskowitz C, Walewski J. Brentuximab vedotin in patients at increased risk of hodgkin lymphoma progression post autologous stem cell transplant: evaluation of healthcare resource utilization in the AETHERA trial. Poster presented at the 20th Congress of the European Hematology Association; June 2015. Vienna, Austria.

Williams V, Coles T, DeMuro C, Lewis S, Williams N, Yarr S, Barghout V, Lowes L, Alfano L, Goldberg B, Gnanasakthy A, Tseng B. Psychometric evaluation of the Sporadic Inclusion Body Myositis (sIBM) Physical Functioning Assessment (sIFA). Poster presented at the 1st Annual International Conference on Myositis; May 2015. Stockholm, Sweden.

Copley-Merriman C, Zelt S, Clark M, Gnanasakthy A. Benefits of patient-reported outcomes in dermatology drug development. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

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, Lewis S, Lowes L, Tseng B, Gnanasakthy A. A novel measure to assess self-reported physical functioning in patients with sporadic inclusion body myositis. Poster presented at the 2015 ISPOR 20th Annual International Meeting; May 2015. Philadelphia, PA.

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.

Spelman LJ, Lebwohl M, Mordin M, Mallya UG, Gnanasakthy A, Fox T. Secukinumab treatment provides fast relief from patient-reported psoriasis burden. Poster presented at the 48th Australasian College of Dermatologists Annual Scientific Meeting; May 2015. Adelaide, Australia. [abstract] Australas J Dermatol. 2015 May; 56(Suppl 2):73.

Gnanasakthy A, DeMuro C, Lewis S, Tseng B. Development of a disease model for sporadic inclusion body myositis. 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

Basch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ, Kluetz PG. Patient-reported outcomes in cancer drug development and US regulatory review perspectives from industry, the Food and Drug Administration, and the patient. JAMA Oncol. 2015 Apr 16. doi: 10.1001/jamaoncol.2015.0530

Gnanasakthy A, DeMuro-Mercon CJ. Logistical considerations for intergrating patient-reported outcomes in multiregional clinical trials. Clinical Researcher. 2015 Apr;45-8.

Stull D, McBride D, Houghton K, Finlay A, Gnanasakthy A, Balp MM. Correlations between changes in urticaria activity score, dermatologic-related quality of life, and urticaria-specific quality of life: results from the Ph III trials of omalizumab in CIU/CSU patients. Poster presented at the American Academy of Dermatology 72nd Annual Meeting; March 21, 2015. Denver, CO.

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

Hirsch JD, Gnanasakthy A, Lale R, Choi K, Sarkin AJ. Efficacy of canakinumab vs. triamcinolone acetonide according to multiple gouty arthritis-related health outcomes measures. Int J Clin Pract. 2014 Dec;68(12):1503-7. doi: 10.1111/ijcp.12521

Stull D, McBride D, Houghton K, Finlay A, Gnanasakthy A, Balp M-M. A positive correlation between changes in urticaria symptoms (UAS7) and dermatologic-related quality of life (DLQI) and urticaria-specific quality of life (CU-Q2oL): is it informative about the response to treatment in CSU/CIU patients? Poster presented at the European Academy of Dermatology and Venereology; October 11, 2014. Amsterdam, the Netherlands. Previously presented at the Fall Clinical Dermatology Conference.

Stull D, McBride D, Houghton K, Finlay A, Gnanasakthy A, Balp M-M. Correlation between changes in urticaria symptoms and sleep experience in patients with chronic spontaneous/idiopathic urticaria (CSU/CIU): results from two randomised, double-blind, placebo-controlled phase III trials of omalizumab. Poster presented at the European Academy of Dermatology and Venereology; October 8, 2014. Amsterdam, the Netherlands. Previously presented at the Fall Clinical Dermatology Conference.

Lebwohl M, Mordin MM, Mallya UG, Gnanasakthy A, Fox T. Secukinumab treatment provides fast relief from patient-reported psoriasis burden. Poster presented at the 23rd European Academy of Dermatology and Venereology Congress; October 2, 2014. Amsterdam, The Netherlands.

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.

Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nelson LM, McLeod LD, Mordin M, Gottlieb A, Elewski B, Lebwohl MG. Psychometric evaluation of the Psoriasis Symptom Diary using phase 3 trial data. Poster presented at the 2014 ISPOR 19th Annual International Meeting; May 2014. Montreal, Canada. [abstract] Value Health. 2014 Jun; 17(3):A288. doi: 10.1016/j.jval.2014.03.1676

Stull D, McBride D, Houghton K, Finlay A, Gnanasakthy A, Balp MM. Changes in urticaria symptoms, dermatologic-related quality of life, and urticaria-specific quality of life: are they telling us the same thing about response to treatment for chronic spontaneous/idiopathic urticaria (CSU/CIU)? Poster presented at the European Academy of Allergy and Clinical Immunology Congress; June 2014. Copenhagen, Denmark.

Gottlieb A, Zhang J, Gnanasakthy A, Tran MH, Strober B. Secukinumab's time to psoriasis response on patient-reported psoriasis symptoms (ERASURE Study). Poster presented at the 72nd Annual Meeting of the American Academy of Dermatology; March 21, 2014. Denver, CO.

Stull DE, McBride D, Gnanasakthy A, Balp M. Correlations between changes in the urticaria activity score (UAS7) and the dermatology life quality index (DLQI) from baseline to 28 or 40 weeks: comparisons of trajectories of change in patients with chronic spontaneous/idiopathic urticaria (CSU/CIU). Poster presented at the 2013 ISPOR 16th Annual European Congress; November 2013. [abstract] Value Health. 2013 Nov; 16(7):A509.

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