A decision-theoretic phase I-II design for ordinal outcomes in two cycles.

@article{Lee2016ADP,
  title={A decision-theoretic phase I-II design for ordinal outcomes in two cycles.},
  author={Juhee Lee and Peter F. Thall and Yuan Ji and Peter Mueller},
  journal={Biostatistics},
  year={2016},
  volume={17 2},
  pages={304-19}
}
This paper is motivated by a phase I-II clinical trial of a targeted agent for advanced solid tumors. We study a stylized version of this trial with the goal to determine optimal actions in each of two cycles of therapy. A design is presented that generalizes the decision-theoretic two-cycle design of Lee and others (2015. Bayesian dose-finding in two treatment cycles based on the joint utility of efficacy and toxicity. Journal of the American Statistical Association, to appear) to accommodate… CONTINUE READING
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