کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10908850 | 1087812 | 2014 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Challenges of phase III trial design for novel treatments in diseases with no standard treatment: The AZA-001 myelodysplasia study model
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
تحقیقات سرطان
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چکیده انگلیسی
For cancers lacking standard treatments, comparing new agents with existing treatments is problematic. Here we discuss the study design from the AZA-001 trial, which compared azacitidine with 3 frequently used conventional care regimens (CCR) for higher-risk myelodysplastic syndromes. Before randomization, physicians preselected the most appropriate of 3 CCR for each patient, after thorough examination. Patients were then randomized to azacitidine or CCR. Patients randomized to CCR received their preselected treatment, thus including patients otherwise excluded as poor candidates for a single comparator. This design may serve as a template in other cancers lacking standard therapy.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Leukemia Research - Volume 38, Issue 2, February 2014, Pages 258-262
Journal: Leukemia Research - Volume 38, Issue 2, February 2014, Pages 258-262
نویسندگان
Pierre Fenaux, John F. Seymour, Valeria Santini, Lew Silverman, Steven Gore, Alan List, Guillermo Sanz, Ghulam J. Mufti, Eli Estey, Arlene S. Swern, C.L. Beach, Eva Hellstrom-Lindberg,