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Research ArticleOpen accessIn the keywordsATLCEP: A New Integrated Design that Encompasses the Safety and Efficacy Objectives of Phase I/II TrialsRevathi Ananthakrishnan, Stephanie Green, Mark Chang et al.Several designs, such as designs to find the optimal biological dose, the Eff-Tox design and seamless Phase I/II designs, have been proposed to evaluate both drug toxicity and efficacy as alternatives to the traditional paradigm of a stepwise drug development approach. Here, we first examine the effect of sample and cohort size on the accuracy of dose selection in early … …Current Research in Biostatistics, Vol. 7, Issue 2 · 7 Apr 2018 · 7,980 accessesView PDF Cite

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