کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3945807 1254292 2010 4 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Trial design for evaluation of novel targeted therapies
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی زنان، زایمان و بهداشت زنان
پیش نمایش صفحه اول مقاله
Trial design for evaluation of novel targeted therapies
چکیده انگلیسی

ObjectivesThe 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.MethodsNovel techniques for phase II trials were researched in the literature. Incorporation of surrogate endpoints and novel approaches were identified.ResultsPhase 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 design could allow for more accurate identification of patients who will benefit from targeted therapies. Tumor response as measured by anatomic imaging has been used to measure therapeutic efficacy in the era of cytotoxic drugs. Fluorodeoxyglucose (FDG)-positron emission tomography (PET) however, has been used increasingly in the evaluation of biologic responses.ConclusionsAlternatives to traditional phase II trial design including alternative end points, randomized designs, biomarkers, and imaging tools should allow ineffective agents to be discarded and promising agents to undergo further investigation.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Gynecologic Oncology - Volume 116, Issue 2, February 2010, Pages 173–176
نویسندگان
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