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Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.
Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Kim J, et al. Among authors: ayalew k. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. doi: 10.1158/1078-0432.CCR-17-2555. Epub 2017 Dec 13. Clin Cancer Res. 2018. PMID: 29237718 Review.
Challenges with Novel Clinical Trial Designs: Master Protocols.
Cecchini M, Rubin EH, Blumenthal GM, Ayalew K, Burris HA, Russell-Einhorn M, Dillon H, Lyerly HK, Reaman GH, Boerner S, LoRusso PM. Cecchini M, et al. Among authors: ayalew k. Clin Cancer Res. 2019 Apr 1;25(7):2049-2057. doi: 10.1158/1078-0432.CCR-18-3544. Epub 2019 Jan 29. Clin Cancer Res. 2019. PMID: 30696689
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Ayalew K, Ning YM, Foringer MJ, Leibenhaut S, Sellers JW, Yu B, Kronstein PD, Higgerson A, Mihaescu C, Rodriguez M, Williams L, Khin NA. Ayalew K, et al. Ther Innov Regul Sci. 2023 Jan;57(1):79-85. doi: 10.1007/s43441-022-00441-w. Epub 2022 Aug 16. Ther Innov Regul Sci. 2023. PMID: 35972722 Free PMC article.
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Khin NA, Grandinetti C, Dixey H, Yu B, Skeete R, Ayalew K, Budwal-Jagait M, Cho SJ, Dasgupta A, Fisher A, Kleppinger C, Kronstein PD, Martin J, McGuinness M, Mulinde J, Vinter S, Wakelin-Smith J, Walker P, Francis G. Khin NA, et al. Among authors: ayalew k. Clin Pharmacol Ther. 2022 Jul;112(1):31-43. doi: 10.1002/cpt.2386. Epub 2021 Aug 30. Clin Pharmacol Ther. 2022. PMID: 34358334
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Sellers JW, Mihaescu CM, Ayalew K, Kronstein PD, Yu B, Ning YM, Rodriguez M, Williams L, Khin NA. Sellers JW, et al. Among authors: ayalew k. Ther Innov Regul Sci. 2022 Sep;56(5):765-766. doi: 10.1007/s43441-022-00423-y. Ther Innov Regul Sci. 2022. PMID: 35637424 Free PMC article. No abstract available.
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, Ayalew K, Cho SJ, Fisher A, Kleppinger C, Ayala R, Bonapace C, Dasgupta A, Kronstein PD, Vinter S. Khin NA, et al. Among authors: ayalew k. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
Action for Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials-Is Africa the Answer? Report From a Satellite Session of the Accelerating Anti-Cancer Agent Development and Validation Workshop.
Kizub D, Manner CK, Graef K, Abubakar B, Orem J, Odedina F, Adeyeye MC, Nakigudde G, Ayalew K, Kalidas C, Lyerly HK, Norman T, Fashoyin-Aje L, Freedman J, Dent J, Cance B, Gralow J. Kizub D, et al. Among authors: ayalew k. JCO Glob Oncol. 2022 Jun;8:e2200117. doi: 10.1200/GO.22.00117. JCO Glob Oncol. 2022. PMID: 35714309 Free PMC article.
35 results