کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3463024 1231527 2011 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
An evaluation of a Simon 2-Stage phase II clinical trial design incorporating toxicity monitoring
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
پیش نمایش صفحه اول مقاله
An evaluation of a Simon 2-Stage phase II clinical trial design incorporating toxicity monitoring
چکیده انگلیسی

Phase II clinical trials are usually designed to measure efficacy but patient safety is also a very important aspect. Previous authors suggested a methodology that allows one to monitor the cumulative number of toxic events after each patient is treated, which is also known as continuous toxicity monitoring. In this work we describe how to combine the continuous toxicity monitoring methodology with the Simon 2-Stage design for response. Then we investigate through simulation the combined procedure's type I and type II error rates under various combinations of design parameters. We include the underlying relationship between toxicity and response in our examination of the error rates.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials - Volume 32, Issue 3, May 2011, Pages 428–436
نویسندگان
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