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爱思唯尔期刊精选全文
标题:用于评估新靶向治疗方法的试验设计
Gynecologic Oncology, 2010, Volume: 116, Issue: 2
作者:John Farley and Peter G. Rose
内容预览:Abstract
Objectives
The vast number of novel targeted therapies available for testing in the United States dictates that a more efficient system aimed at identifying promising agents for phase III testing needs to be developed. Alternatives to traditional phase II trial design including alternative end points, randomized designs, biomarkers, and imaging tools are discussed.
Methods
Novel techniques for phase II trials were researched in the literature. Incorporation of surrogate endpoints and novel approaches were identified.
Results
Phase II trials are traditionally designed evaluating response rates compared to historical controls. In addition to identifying surrogates, novel approaches to phase II study design need to be tested. Incorporation of biomarkers into phase II trial...
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