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