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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: donoghue m. 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.
Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial.
Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, Zhao H, Marathe A, Kotch L, Jee J, Wang Y, Zhou L, Adams WM, Jarral V, Pilaro A, Lostritto R, Gootenberg JE, Keegan P, Pazdur R. Donoghue M, et al. Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26. Clin Cancer Res. 2012. PMID: 22282463
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.
Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Kluetz PG, et al. Among authors: donoghue m. Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12. Clin Cancer Res. 2016. PMID: 26758559
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.
Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Kluetz PG, et al. Among authors: donoghue m. Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. Clin Cancer Res. 2016. PMID: 28151715 Free PMC article. No abstract available.
Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Minimum Age Working Group.
Gore L, Ivy SP, Balis FM, Rubin E, Thornton K, Donoghue M, Roberts S, Bruinooge S, Ersek J, Goodman N, Schenkel C, Reaman G. Gore L, et al. Among authors: donoghue m. J Clin Oncol. 2017 Nov 20;35(33):3781-3787. doi: 10.1200/JCO.2017.74.4144. Epub 2017 Oct 2. J Clin Oncol. 2017. PMID: 28968169 Free PMC article.
FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.
Odogwu L, Mathieu L, Goldberg KB, Blumenthal GM, Larkins E, Fiero MH, Rodriguez L, Bijwaard K, Lee EY, Philip R, Fan I, Donoghue M, Keegan P, McKee A, Pazdur R. Odogwu L, et al. Among authors: donoghue m. Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425. Epub 2017 Dec 14. Oncologist. 2018. PMID: 29242281 Free PMC article. Clinical Trial.
355 results