Decision Tables for Calibration-Free Odds Design in Phase I Clinical Trials.

Abstract

In clinical trials, the initial step typically involves assessing a new drug's toxicity profile, aiming to identify a tolerable dose level for subsequent studies. In phase I trials, the primary objective is to determine the maximum tolerated dose, defined as the highest dose associated with an acceptable level of toxicity. Numerous methods have been developed to guide dose escalation and de-escalation decisions during trial conduct. Among these approaches, the calibration-free odds (CFO) design has demonstrated superior operating characteristics and has emerged as one of the most effective approaches for dose finding. To facilitate the application of the CFO design in clinical trial practice, an R package and a Shiny app have been released. This study presents CFO decision tables in Excel files to further remove the barrier of applying the CFO design to real trials. Anyone involved in the trial conduct can implement the CFO design with no difficulties. During the trial, dose movement decisions can be made simply by referring to the cumulative data (including numbers of patients treated and observed toxicities) and the pregenerated decision tables, without any additional statistical calculation. This approach significantly enhances the usability of the CFO design and reduces the operational complexity associated with its implementation in clinical trials. The Excel CFO decision tables can be downloaded from CFO Shiny App.