选择 II 期终点和设计：评估可能性。
Choosing phase II endpoints and designs: evaluating the possibilities.
机构信息
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, USA.
出版信息
Clin Cancer Res. 2012 Apr 15;18(8):2130-2. doi: 10.1158/1078-0432.CCR-12-0454. Epub 2012 Mar 8.
Abstract
Selecting the phase II design and endpoint to achieve the best possible chance of success for a confirmatory phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets and from mathematical models can be useful tools for evaluating statistical properties.
摘要
在特定疾病和治疗环境下，为确证性 III 期研究选择 II 期设计和终点以获得最佳成功机会具有挑战性，但至关重要。从现有临床试验数据集和数学模型中进行模拟可以成为评估统计性质的有用工具。
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