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Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Kluetz PG, et al. Among authors: fiero mh. Value Health. 2018 Jun;21(6):742-747. doi: 10.1016/j.jval.2017.09.009. Epub 2017 Nov 7. Value Health. 2018. PMID: 29909880 Free article.
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. Among authors: fiero mh. 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.
FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma.
Chang E, Weinstock C, Zhang L, Fiero MH, Zhao M, Zahalka E, Ricks TK, Fourie Zirkelbach J, Qiu J, Yu J, Chen XH, Bhatnagar V, Goldberg KB, Tang S, Kluetz PG, Pazdur R, Ibrahim A, Beaver JA, Amiri-Kordestani L. Chang E, et al. Among authors: fiero mh. Clin Cancer Res. 2022 Feb 1;28(3):441-445. doi: 10.1158/1078-0432.CCR-21-2334. Epub 2021 Aug 20. Clin Cancer Res. 2022. PMID: 34417198 Free PMC article.
U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.
Arora S, Narayan P, Ison G, Berman T, Suzman DL, Wedam S, Prowell TM, Ghosh S, Philip R, Osgood CL, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Arora S, et al. Among authors: fiero mh. Clin Cancer Res. 2022 Mar 15;28(6):1058-1071. doi: 10.1158/1078-0432.CCR-21-2599. Clin Cancer Res. 2022. PMID: 34711631 Free PMC article. Review.
U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.
Arora S, Narayan P, Osgood CL, Wedam S, Prowell TM, Gao JJ, Shah M, Krol D, Wahby S, Royce M, Ghosh S, Philip R, Ison G, Berman T, Brus C, Bloomquist EW, Fiero MH, Tang S, Pazdur R, Ibrahim A, Amiri-Kordestani L, Beaver JA. Arora S, et al. Among authors: fiero mh. Clin Cancer Res. 2022 Mar 15;28(6):1072-1086. doi: 10.1158/1078-0432.CCR-21-2600. Clin Cancer Res. 2022. PMID: 34711632 Free PMC article. Review.
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