A two‐stage phase II clinical trial design with nested criteria for early stopping and efficacy
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چکیده
منابع مشابه
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Purpose: The premise for phase I trials for cytostatic agents is different from that of cytotoxic agents. For cytostatic agents, toxicity and efficacy do not necessarily increase monotonically with increasing dose levels, but likely plateau after they reach maximal toxicity or efficacy. Here, we propose a phase I-II trial design to assess both toxicity and efficacy to find the best dose as well...
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ژورنال
عنوان ژورنال: Pharmaceutical Statistics
سال: 2019
ISSN: 1539-1604,1539-1612
DOI: 10.1002/pst.1965