A robust two-stage design identifying the optimal biological dose for phase I/II clinical trials.

@article{Zang2017ART,
  title={A robust two-stage design identifying the optimal biological dose for phase I/II clinical trials.},
  author={Yong Zang and J Jack Lee},
  journal={Statistics in medicine},
  year={2017},
  volume={36 1},
  pages={27-42}
}
We propose a robust two-stage design to identify the optimal biological dose for phase I/II clinical trials evaluating both toxicity and efficacy outcomes. In the first stage of dose finding, we use the Bayesian model averaging continual reassessment method to monitor the toxicity outcomes and adopt an isotonic regression method based on the efficacy outcomes to guide dose escalation. When the first stage ends, we use the Dirichlet-multinomial distribution to jointly model the toxicity and… CONTINUE READING
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