Publications

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Displaying 1 through 8 of 8 publications.

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

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

Ling W, Nadipelli VR, Ronquest N, Albright VA, Aldridge AP, Learned SM, Mehra V, Heidbreder C. Remission from chronic opioid use-studying environmental and socio-economic factors on recovery (RECOVER): study design and participant characteristics. Contemp Clin Trials. 2019 Jan;76:93-103. doi: 10.1016/j.cct.2018.11.015

Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials. 2015 Apr 18;43:1-9. doi: 10.1016/j.cct.2015.04.004

Gnanasakthy A, DeMuro C, Boulton C. Integration of patient-reported outcomes in multiregional confirmatory clinical trials. Contemp Clin Trials. 2013 May 1;35(1):62-9.

Herring WL, Herrmann JW. The single-day surgery scheduling problem: sequential decision-making and threshold-based heuristics. OR spectrum: quantitative approaches in management. 2012 Apr 1;34(2):429-59.

Hareendran A, Gnanasakthy A, Winnette RM, Revicki D. Capturing patients' perspectives of treatment in clinical trials/drug development. Contemp Clin Trials. 2012 Jan;33(1):23-8.

Stull DE, Wiklund I, Gale R, Capkun-Niggli G, Houghton K, Jones P. Application of latent growth and growth mixture modeling to identify and characterize differential responders to treatment for COPD. Contemp Clin Trials. 2011 Nov 1;32(6):818-28.