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Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition.
Li BT, Daly B, Gospodarowicz M, Bertagnolli MM, Brawley OW, Chabner BA, Fashoyin-Aje L, de Claro RA, Franklin E, Mills J, Legos J, Kaucic K, Li M, The L, Hou T, Wu TH, Albrecht B, Shao Y, Finnegan J, Qian J, Shahidi J, Gasal E, Tendler C, Kim G, Yan J, Morrow PK, Fuchs CS, Zhang L, LaCaze R, Oelrich S, Murphy MJ, Pazdur R, Rudd K, Wu YL. Li BT, et al. Nat Med. 2022 Apr;28(4):620-626. doi: 10.1038/s41591-022-01775-6. Nat Med. 2022. PMID: 35440725 No abstract available.
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health.
Chang E, Pelosof L, Lemery S, Gong Y, Goldberg KB, Farrell AT, Keegan P, Veeraraghavan J, Wei G, Blumenthal GM, Amiri-Kordestani L, Singh H, Fashoyin-Aje L, Gormley N, Kluetz PG, Pazdur R, Beaver JA, Theoret MR. Chang E, et al. Oncologist. 2021 Oct;26(10):e1786-e1799. doi: 10.1002/onco.13887. Epub 2021 Jul 27. Oncologist. 2021. PMID: 34196068 Free PMC article. Review.
FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.
Casak SJ, Pradhan S, Fashoyin-Aje LA, Ren Y, Shen YL, Xu Y, Chow ECY, Xiong Y, Zirklelbach JF, Liu J, Charlab R, Pierce WF, Fesenko N, Beaver JA, Pazdur R, Kluetz PG, Lemery SJ. Casak SJ, et al. Clin Cancer Res. 2022 Jul 1;28(13):2733-2737. doi: 10.1158/1078-0432.CCR-21-4462. Clin Cancer Res. 2022. PMID: 35259259 Free PMC article. Clinical Trial.
The On- and Off-Ramps of Oncology Accelerated Approval.
Fashoyin-Aje LA, Mehta GU, Beaver JA, Pazdur R. Fashoyin-Aje LA, et al. N Engl J Med. 2022 Oct 20;387(16):1439-1442. doi: 10.1056/NEJMp2208954. Epub 2022 Sep 21. N Engl J Med. 2022. PMID: 36129992 No abstract available.
57 results