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✅   UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints

science

A primary objective of oncology dose-finding trials for novel therapies is to determine an optimal biological dose (OBD) that is both tolerable and therapeutically beneficial for patients in subsequent clinical trials. These new therapeutic agents are more likely to induce multiple low- or moderate-grade toxicities rather than dose-limiting toxicities. Additionally, efficacy is evaluated comprehensively, differentiating between complete remission and partial remission, as well as incorporating...

NCBI     May 19, 2025