کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3462937 1231521 2013 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A phase II flexible screening design allowing for interim analysis and comparison with historical control
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
پیش نمایش صفحه اول مقاله
A phase II flexible screening design allowing for interim analysis and comparison with historical control
چکیده انگلیسی

Sargent and Goldberg [1] proposed a randomized phase II flexible screening design (SG design) which took multiple characteristics of candidate regimens into consideration in selecting a regimen for further phase III testing. In this paper, we extend the SG design by including provisions for an interim analysis and/or a comparison to a historical control. By including a comparison with a historical control, a modified SG design not only identifies a more promising treatment but also assures that the regimen has a clinically meaningful level of efficacy as compared to a historical control. By including an interim analysis, a modified SG design could reduce the number of patients exposed to inferior treatment regimens. When compared to the original SG design, the modified designs increase the sample size moderately, but expand the utility of the flexible screening design substantially.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 35, Issue 2, July 2013, Pages 128–137
نویسندگان
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