A novel Phase I clinical trial design with unequal cohort sizes

Abstract

This paper introduces a new Phase I design aimed at enhancing the performance of existing methods, including algorithm-based, model-based, and model-assisted designs. The design, developed by integrating the concept of Fisher information, is easily operationalized. The new design addresses the issue of the classical designs'slow dosage escalation. Simulation demonstrate that the proposed design markedly enhances performance in terms of efficiency, accuracy, and reliability. Moreover, the trial duration has been notably reduced with a large sample size.