A novel Phase I clinical trial design with unequal cohort sizes

TL;DR

This paper presents a new Phase I clinical trial design that improves efficiency, accuracy, and reliability by integrating Fisher information, reducing trial duration and addressing slow dosage escalation issues of classical methods.

Contribution

The paper introduces a novel Phase I trial design that incorporates Fisher information, offering a practical solution to improve performance over existing methods.

Findings

Significantly improved efficiency, accuracy, and reliability.

Reduced trial duration with large sample sizes.

Enhanced performance over classical designs.

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.