Monitoring late-onset toxicities in phase I trials using predicted risks.

@article{Bekele2008MonitoringLT,
  title={Monitoring late-onset toxicities in phase I trials using predicted risks.},
  author={Benjamin Nebiyou Bekele and Yuan Ji and Yu Shen and Peter F. Thall},
  journal={Biostatistics},
  year={2008},
  volume={9 3},
  pages={442-57}
}
Late-onset (LO) toxicities are a serious concern in many phase I trials. Since most dose-limiting toxicities occur soon after therapy begins, most dose-finding methods use a binary indicator of toxicity occurring within a short initial time period. If an agent causes LO toxicities, however, an undesirably large number of patients may be treated at toxic doses before any toxicities are observed. A method addressing this problem is the time-to-event continual reassessment method (TITE-CRM, Cheung… CONTINUE READING