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