A Phase I/II trial design when response is unobserved in subjects with dose-limiting toxicity.

@article{Braun2016API,
  title={A Phase I/II trial design when response is unobserved in subjects with dose-limiting toxicity.},
  author={Thomas M Braun and Shan Kang and Jeremy M. G. Taylor},
  journal={Statistical methods in medical research},
  year={2016},
  volume={25 2},
  pages={
          659-73
        }
}
We propose a Phase I/II trial design in which subjects with dose-limiting toxicity are not followed for response, leading to three possible outcomes for each subject: dose-limiting toxicity, absence of therapeutic response without dose-limiting toxicity, and presence of therapeutic response without dose-limiting toxicity. We define the latter outcome as a 'success,' and the goal of the trial is to identify the dose with the largest probability of success. This dose is commonly referred to as… CONTINUE READING