Dose Escalation

A systematic strategy in early-phase clinical trials for incrementally increasing the dose administered to successive cohorts of participants to identify the maximum tolerated dose and characterize the dose-toxicity relationship. Common designs include the traditional 3+3, modified Fibonacci, Bayesian continual reassessment method (CRM), and accelerated titration. Dose escalation decisions are guided by dose-limiting toxicities observed in each cohort.

Exemplos

• Oncology Phase I: 3+3 design with modified Fibonacci dose increments (100%, 67%, 50%, 33%)
• Bayesian CRM in first-in-human biologics trials with adaptive cohort assignment
• Accelerated titration design: single-patient cohorts with 100% dose increments until first toxicity signal