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To Adjudicate or Not Adjudicate: That Is the Question.
Hicks KA, Fashoyin-Aje LA, Amiri-Kordestani L. Hicks KA, et al. JACC CardioOncol. 2022 Dec 20;4(5):657-659. doi: 10.1016/j.jaccao.2022.11.003. eCollection 2022 Dec. JACC CardioOncol. 2022. PMID: 36636434 Free PMC article.
Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies.
Fallah J, Mulkey F, Fiero MH, Gittleman H, Song C, Puthiamadathil J, Amatya A, Agrawal S, Vellanki P, Suzman DL, Singh H, Amiri-Kordestani L, Mishra-Kalyani P, Pazdur R, Kluetz PG. Fallah J, et al. Among authors: amiri kordestani l. J Clin Oncol. 2024 Nov 10;42(32):3783-3787. doi: 10.1200/JCO-24-01200. Epub 2024 Sep 17. J Clin Oncol. 2024. PMID: 39288354
FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.
Fallah J, Xu J, Weinstock C, Brave MH, Bloomquist E, Fiero MH, Schaefer T, Pathak A, Abukhdeir A, Bhatnagar V, Chiu HJ, Ricks T, John C, Hamed S, Lee C, Pierce WF, Kalavar S, Philip R, Tang S, Amiri-Kordestani L, Pazdur R, Kluetz PG, Suzman D. Fallah J, et al. J Clin Oncol. 2024 Feb 10;42(5):605-613. doi: 10.1200/JCO.23.01868. Epub 2023 Dec 21. J Clin Oncol. 2024. PMID: 38127780 Clinical Trial.
Methodology for Good Machine Learning with Multi-Omics Data.
Coroller T, Sahiner B, Amatya A, Gossmann A, Karagiannis K, Moloney C, Samala RK, Santana-Quintero L, Solovieff N, Wang C, Amiri-Kordestani L, Cao Q, Cha KH, Charlab R, Cross FH Jr, Hu T, Huang R, Kraft J, Krusche P, Li Y, Li Z, Mazo I, Paul R, Schnakenberg S, Serra P, Smith S, Song C, Su F, Tiwari M, Vechery C, Xiong X, Zarate JP, Zhu H, Chakravartty A, Liu Q, Ohlssen D, Petrick N, Schneider JA, Walderhaug M, Zuber E. Coroller T, et al. Clin Pharmacol Ther. 2024 Apr;115(4):745-757. doi: 10.1002/cpt.3105. Epub 2024 Jan 31. Clin Pharmacol Ther. 2024. PMID: 37965805
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.
Donaldson JM, Seddiq M, Fusco MJ, Singla S, Pamuk GE, Lee-Alonso RJ, Mixter BD, Goldberg KB, Amiri-Kordestani L, de Claro RA, Drezner N, Gormley NJ, Kanapuru B, Lemery SJ, Fashoyin-Aje LA, Richardson NC, Singh H, Suzman DL, Theoret MR, Kluetz PG, Pazdur R. Donaldson JM, et al. Cancer Discov. 2023 Dec 12;13(12):2515-2524. doi: 10.1158/2159-8290.CD-23-1226. Cancer Discov. 2023. PMID: 38084090
Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement.
Cui W, Rocconi RP, Thota R, Anderson RA, Bruinooge SS, Comstock IA, Denduluri N, Gassman A, Gralow J, Hutt KJ, Amiri-Kordestani L, Lambertini M, Leighton J, Lu KH, Mostoufi-Moab S, Pollastro T, Pradhan S, Saber H, Schenkel C, Spratt D, Wedam S, Phillips KA. Cui W, et al. Lancet Oncol. 2023 Oct;24(10):e415-e423. doi: 10.1016/S1470-2045(23)00390-X. Lancet Oncol. 2023. PMID: 37797647 Review.
US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.
Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. Heiss BL, et al. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7. J Clin Oncol. 2024. PMID: 38452327 Clinical Trial.
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