Publications

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Displaying 1 through 50 of 105 publications.

Gnanasakthy A, Norcross L, Fitzgerald K. Editorial - Assessment of patient-reported outcomes in industry-sponsored phase 1 oncology studies: considerations for translating theory into practice. Value Health. 2023 Jun 21;26(10):1440-3. doi: 10.1016/j.jval.2023.06.006

Mordin M, Castro C, Gnanasakthy A. Trends in the inclusion of patient reported outcomes in oncology clinical trials: analysis of clinicaltrials.gov (2013-2022). Poster presented at the ISPOR 2023 Conference; May 8, 2023. Boston, MA. [abstract] Value Health. 2023 Jun; 26(6 supplement):S325. doi: 10.1016/j.jval.2023.03.1852

Gnanasakthy A, Levy C, Norcross L, Doward L, Winnette R. A review of labeling based on PRO endpoints for new oncology drugs approved by the European Medicines Agency (2017-2021). Value Health. 2023 Jun;26(6):893-901. doi: 10.1016/j.jval.2023.01.017

Gnanasakthy A, Norcross L, Clark M, Fitzgerald K. A review of patient-reported outcome considerations in oncologic drug advisory committee meetings (2016-2021). JCO Oncol Pract. 2023 May;19(5):e745-62. doi: 10.1200/OP.22.00774

Forsythe E, Haws RM, Argente J, Beales P, Martos-Moreno GA, Dollfus H, Chirila C, Gnanasakthy A, Buckley BC, Mallya UG, Clement K, Haqq AM. Quality of life improvements following one year of setmelanotide in children and adult patients with Bardet-Biedl syndrome: phase 3 trial results. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. doi: 10.1186/s13023-022-02602-4

Gnanasakthy A, Qin S, Norcross L. Editorial - FDA guidance on selecting, developing, or modifying fit-for-purpose clinical outcome assessments: old wine in a new bottle? Patient. 2023 Jan. doi: 10.1007/s40271-022-00607-6

Spira A, Zhou X, Liao L, Yu E, Chen L, Lau A, Wang Y, Gnanasakthy A, Radford J, Hamadani M. Health-related quality of life and tolerability in patients with/without skin toxicity during loncastuximab tesirine treatment in a phase 2 clinical trial (LOTIS-2). Poster presented at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022); September 28, 2022. Houston, TX.

Wainberg ZA, Enzinger PC, Qin S, Yamaguchi K, Gnanasakthy A, Taylor K, Jamotte A, Majer I, Kang YK. Health-related quality of life (HRQoL) in FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer (G/GEJC): results from the FIGHT trial comparing bemarituzumab (BEMA) + modified FOLFOX6 (mFOLFOX6) to placebo (PBO) + mFOLFOX6. Poster presented at the 2022 ESMO Annual Conference; September 9, 2022. Paris, France.

Lu E, Gnanasakthy A, Xie J, Latour A. Recognizing cultural diversity in patient-centered outcomes for healthcare decision making. Presented at the Vitrual ISPOR Asia Pacific 2022; September 2022.

Gnanasakthy A, Russo J, Gnanasakthy K, Harris N, Castro C. A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018). Contemp Clin Trials. 2022 Sep;120:106860. doi: 10.1016/j.cct.2022.106860

Spira A, Liao L, Zhou X, Gnanasakthy A, Chen L, Ungar D, Yu E, Kilavuz T, Radford J, Hamadani M. Health-related quality of life and tolerability of loncastuximab tesirine in high-risk patients with relapsed/refractory diffuse large B-cell lymphoma treated in a phase 2 clinical trial (LOTIS 2). Poster presented at the 2022 EHA Congress; June 9, 2022. Vienna, Austria.

Gnanasakthy A, Crawford R, Qin S, Bender R, Doward L. Advanced patient-reported outcomes. Presented at the 2022 ISPOR Virtual Short Course Program; June 8, 2022.

Romano C, Harris N, Gnanasakthy A, D'Alessio D, Chandiwana D. Patient experiences with patient-reported outcome measures in metastatic breast cancer trials: qualitative interviews. J Patient Rep Outcomes. 2022 Jun 3;6(1):60. doi: 10.1186/s41687-022-00460-z

Cruz Rivera S, Aiyegbusi OL, Ives J, Draper H, Mercieca-Bebber R, Ells C, Hunn A, Scott JA, Fernandez CV, Dickens AP, Anderson N, Bhatnagar V, Bottomley A, Campbell L, Collett C, Collis P, Craig K, Davies H, Golub R, Gosden L, Gnanasakthy A, Haf Davies E, von Hildebrand M, Lord JM, Mahendraratnam N, Miyaji T, Morel T, Monteiro J, Zwisler AO, Peipert JD, Roydhouse J, Stover AM, Wilson R, Yap C, Calvert MJ. Ethical considerations for the inclusion of patient-reported outcomes in clinical research: the PRO ethics guidelines. JAMA. 2022 May 17;327(19):1910-9. doi: 10.1001/jama.2022.6421

Gnanasakthy A, Norcross L, (DeMuro) Romano C, Carson RT. A review of patient-reported outcome labeling of FDA-approved new drugs (2016-2020): counts, categories, and comprehensibility. Value Health. 2022 Apr;25(4):647-55. doi: 10.1016/j.jval.2021.10.006

Spira A, Zhou X, Chen L, Gnanasakthy A, Wang L, Ungar D, Curiel R, Liao L, Radford J, Kahl B. Health-related quality of life, symptoms, and tolerability of Loncastuximab Tesirine in patients with relapsed or refractory diffuse large b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Mar;22(3):158-68. doi: 10.1016/j.clml.2021.09.001

Kuhnen P, Wabitsch M, von Schnurbein J, Chirila C, Mallya UG, Callahan P, Gnanasakthy A, Poitou C, Krabusch PM, Stewart M, Clement K. Quality of life outcomes in two phase 3 trials of setmelanotide in patients with obesity due to LEPR or POMC deficiency. Orphanet J Rare Dis. 2022 Feb 5;17(1):38. doi: 10.1186/s13023-022-02186-z

Forsythe E, Haws RM, Argente J, Beales P, Chirila C, Clement K, Dollfus H, Martos-Moreno GA, Gnanasakthy A, Buckley BC, Mallya U, Haqq AM. Quality of life in patients with bardet-biedl syndrome in a setmelanotide phase 3 trial. Poster presented at the 2021 Obesity Week Virtual Conference; November 1, 2021.

Gnanasakthy A. Editorial - FDA guidance on assessment of patient‑reported outcomes in cancer trials: a breath of fresh air or a storm in a teacup? Patient. 2021 Nov;14(6):695-7. doi: 10.1007/s40271-021-00542-y

Kuhnen P, Wabitsch M, von Schnurbein J, Chirila C, Mallya UG, Callahan P, Gnanasakthy A, Poitou C, Krabusch PM, Stewart M, Clement K. Quality of life in POMC or LEPR deficiency: setmelanotide phase 3 trials. Poster presented at the 2021 Virtual Overcoming Obesity Conference; October 14, 2021.

Gnanasakthy A, Barrett A, Norcross L, D’Alessio D, Romano (DeMuro) C. Use of patient and investigator global impression scales: a review of Food and Drug Administration–approved labeling, 2009 to 2019. Value Health. 2021 Jul;24(7):1016-23. doi: 10.1016/j.jval.2021.01.005

Chirila C, Odom D, Gnanasakthy A. Patient-reported outcomes assessment scheduling in oncology: are we introducing potential bias? Presented at the 2021 DIA Virtual Annual Meeting; June 27, 2021.

Spira AI, Chen L, Zhou X, Gnanasakthy A, Wang L, Ungar D, Curiel R, Radford JA, Kahl BS. Symptoms, health-related quality of life, and tolerability of loncastuximab tesirine in patients with relapsed or refractory diffuse large b cell lymphoma. Blood. 2020 Nov 5;136(Suppl 1):3-4. doi: 10.1182/blood-2020-139571

DiBenedetti D, Gnanasakthy A. The strategic, labeling, and methodologic considerations for patient experience data. Presented at the 2020 ISPOR Boston Seminar; June 29, 2020.

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.

Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos MA. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: the TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-58. doi: 10.1111/ejh.13379.

Gnanasakthy A, Barrett A, D'Alessio D, Norcross L. Review of patient and clinician global assessments in PRO labeling (2017-2019). Poster presented at the ISPOR Virtual 2020 Conference; May 2020. [abstract] Value Health. 2020 May 1; 23(Suppl 1):S299. doi: 10.1016/j.jval.2020.04.094

Barrett A, Hahn-Pedersen J, Kragh N, Evans E, Gnanasakthy A. Patient-reported outcome measures in atopic dermatitis and chronic hand eczema in adults. Poster presented at the ISPOR 2019 European Conference; November 4, 2019. Copenhagen, Denmark. [abstract] Value Health. 2019 Dec; 22(S3).

Barrett A, Hahn-Pedersen J, Kragh N, Evans E, Gnanasakthy A. Patient-reported outcome measures in atopic dermatitis and chronic hand eczema in adults. Patient. 2019 Oct;12(5):445-9. doi: 10.1007/s40271-019-00373-y

Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Odom D, Gnanasakthy A, Suryanarayan K, Cain L, Romanus D, Rajkumar SV, Dimopoulos MA. Health-related quality of life (HRQOL) outcomes of oral ixazombi maintenance therapy post autologous stem cell transplant (ASCT) in newly diagnosed mulitple myeloma (NDMM) from TOURMALINE-MM3. Poster presented at the 24th Congress of the European Hematology Association; June 2019. Amsterdam, The Netherlands. [abstract] Hemasphere. 2019 Jun; 3:266-7.

Kummar S, Mascarenhas L, Geoerger B, Turpin B, Cox, MC, Yu S, Nanda S, Hiemeyer F, Keating KN, Chirila C, Gnanasakthy A, Davenport E, Hong DS, Drilon AE. Patient-reported outcomes from two global multicenter clinical trials of children and adults with tropomyosin receptor kinase (TRK) fusion cancer receiving larotrectinib. Poster presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; June 1, 2019. Chicago, IL. [abstract] J Clin Oncol. 2019 Jun; 37(2019):6602.

Zhou X, Garbinsky D, Gnanasakthy A. Methods for reporting the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data in cancer clinical trials. Poster presented at the 2019 Duke Industry Statistics Symposium (DISS); April 11, 2019. Durham, NC. Previously presented at the ISPOR 23rd Annual International Meeting.

Gnanasakthy A, Barrett A, Evans E, D'Alessio D, Romano (DeMuro) C. A review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012-2016). Value Health. 2019 Feb;22(2):203-9. doi: 10.1016/j.jval.2018.09.2842

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

Zhou X, Eid D, Gnanasakthy A. Methods for reporting the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) data in cancer clinical trials. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 21, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S226. doi: 10.1016/j.jval.2018.04.1528

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.

Martin SA, Olayinka-Amao OC, Henke C, Kamudoni P, Gnanasakthy A. Conceptual model and instrument review in multiple sclerosis. Poster presented at the 2017 ISPOR 20th Annual European Congress; November 7, 2017. Glasgow, Scotland.

Elewski BE, Puig L, Mordin M, Gilloteau I, Sherif B, Fox T, Gnanasakthy A, Papavassilis C, Strober BE. Psoriasis patients with Psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75-89 response: results from two phase 3 studies of secukinumab. J Dermatolog Trea. 2017 Sep;28(6):492-9. doi: 10.1080/09546634.2017.1307464

Gnanasakthy A. Strategies for including patient-reported outcomes in research. Presented at the 2017 ASCO Annual Meeting; June 3, 2017. Chicago, IL.

Martin S, Pawer V, Harris N, Gnanasakthy A. Symptoms of gastric cancer from a patient perspective. Poster presented at the ESMO 19th World Congress on Gastrointestinal Cancer; June 28, 2017. Barcelona, Spain. [abstract] Ann Oncol. 2017 Jun; 28(Suppl 3).

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.