Publications
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Sauchelli S, Chicklis EK, Carty MK, Gnanasakthy A. Use of diaries to capture patient-reported outcomes in FDA new drug approvals (2019-2023). Poster presented at the ISPOR 2025; May 14, 2025. Montréal, Canada.
Gnanasakthy A, Crawford R, Qin S, Doward L, Rockwood NJ. Advanced patient-reported outcomes. Mastering Patient-Reported Outcomes (PRO) in Drug Development. Presented at the ISPOR 2025; May 13, 2025. Montréal, Canada. Previously presented at the ISPOR Europe 2024.
Sauchelli S, Levy C, Gnanasakthy A, Dave V, Doward L, Fitzgerald KA, Carson R. From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018-2022). Front Pharmacol. 2025 Apr 11;16:1536401. doi: 10.3389/fphar.2025.1536401
Wainberg ZA, Enzinger PC, Qin S, Yamaguchi K, Wang J, Zhou X, Gnanasakthy A, Taylor K, Yusuf A, Maher I, Jamotte A, Kang YK. Health-related quality of life with bemarituzumab plus mFOLFOX6 in patients with FGFR2b-overexpressing, advanced gastric or gastroesophageal junction cancer. ESMO gastrointestinal oncology. 2024 Dec;6. doi: 10.1016/j.esmogo.2024.100095
Gnanasakthy A, Crawford R, Qin S, Doward L, Rockwood NJ. Advanced patient-reported outcomes. Presented at the ISPOR Europe 2024; November 17, 2024. Barcelona, Spain. Previously presented at the ISPOR 2024.
Sauchelli S, Levy C, Gnanasakthy A, Doward L, Fitzgerald K. Inclusion of patient-reported outcome endpoints in the summary of product characteristics for non-oncology drugs approved by the European Medicines Agency (2018-2022). Poster presented at the ISOQOL 31st Annual Conference; October 13, 2024. Cologne, Germany.
Yap C, Aiyegbusi OL, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck AC, Gilbert A, Gnanasakthy A, Greystoke A, Hansen AR, Kamudoni P, Kholmanskikh O, King-Kallimanis BL, Krumbolz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell KR, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour LK, Weber HA, Wilson R, Calvert M, Peipert JD. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine. 2024 Oct;76:102838. doi: 10.1016/j.eclinm.2024.102838
Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011
Gnanasakthy A, Crawford R, Qin S, Rockwood N, Doward L. Advanced patient-reported outcomes. Presented at the ISPOR 2024; May 5, 2024.
Gnanasakthy A, Romano DeMuro C. Editorial - The limitations of EQ‑5D as a clinical outcome assessment tool. Patient. 2024 May;17(3):215-7. doi: 10.1007/s40271-024-00683-w
Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146
Aiyegbusi OL, Cruz Rivera S, Roydhouse J, Kamudoni P, Alder Y, Anderson N, Baldwin RM, Bhatnagar V, Black J, Bottomley A, Brundage M, Cella D, Collis P, Davies EH, Denniston AK, Efficace F, Gardner A, Gnanasakthy A, Golub RM, Hughes SE, Jeyes F, Kern S, King-Kallimanis BL, Martin A, McMullan C, Mercieca-Bebber R, Monteiro J, Peipert JD, Quijano-Campos JC, Quinten C, Rantell KR, Regnault A, Sasseville M, Schougaard LMV, Sherafat-Kazemzadeh R, Snyder C, Stover AM, Verdi R, Wilson R, Calvert MJ. Recommendations to address respondent burden associated with patient-reported outcome assessment. Nat Med. 2024 Mar;30(3):650-9. doi: 10.1038/s41591-024-02827-9
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 patient reported outcome 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
Gnanasakthy A, Crawford R, Qin S, Bender R, Doward L. Advanced patient-reported outcomes. Presented at the 2023 ISPOR Virtual Short Course Program; March 8, 2023.
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