کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8757622 1596412 2018 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Limb-Leaf designs for adaptive exploration of the dose-response curve
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
پیش نمایش صفحه اول مقاله
Limb-Leaf designs for adaptive exploration of the dose-response curve
چکیده انگلیسی
We propose a two-stage strategy, called the Limb-Leaf method, to explore the dose-response curve using dose promotion and addition in the context of adaptive seamless Phase II/III trials. Strong control of the overall type 1 familywise error rate of the proposed method is enforced by the closed testing principle. The design constants are determined to minimize the risk-adjusted expected total sample size while maintaining a target power. In the case of a nonmonotonic dose response curve where more doses are required to adequately explore the curve, substantial savings in sample size are achieved compared with a traditional strategy which offers only selection and promotion from among initial first stage doses.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 64, January 2018, Pages 210-218
نویسندگان
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