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
Franklin JM, Dejene S, Huybrechts KF, Wang SV, Kulldorff M, Rothman KJ. A bias in the evaluation of bias comparing randomized trials with nonexperimental studies. Epidemiol Methods. 2017 Apr;6(1):20160018.. doi: 10.1515/em-2016-0018.