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
Strand V, Kaeley GS, Bergman MJ, Gladman DD, Coates LC, Sherif B, Hur P, Parikh B, Gilloteau I, Mease PJ. The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomized phase 3 trial. Lancet Rheumatol. 2022 Mar 1;4(3):e208-19.