AI Article Synopsis

  • The new calibration-free odds (CFO) design is a phase I trial method that is robust, simple to use, and does not rely on specific models.
  • However, it previously struggled with late-onset toxicities commonly seen in oncology trials, prompting the development of a time-to-event version (TITE-CFO).
  • The TITE-CFO design improves efficiency by using game theory to analyze three doses simultaneously, demonstrating better performance than traditional interval-based methods in trials with late-onset toxicity outcomes.

Article Abstract

Compared with most of the existing phase I designs, the recently proposed calibration-free odds (CFO) design has been demonstrated to be robust, model-free, and easy to use in practice. However, the original CFO design cannot handle late-onset toxicities, which have been commonly encountered in phase I oncology dose-finding trials with targeted agents or immunotherapies. To account for late-onset outcomes, we extend the CFO design to its time-to-event (TITE) version, which inherits the calibration-free and model-free properties. One salient feature of CFO-type designs is to adopt game theory by competing three doses at a time, including the current dose and the two neighboring doses, while interval-based designs only use the data at the current dose and is thus less efficient. We conduct comprehensive numerical studies for the TITE-CFO design under both fixed and randomly generated scenarios. TITE-CFO shows robust and efficient performances compared with interval-based and model-based counterparts. As a conclusion, the TITE-CFO design provides robust, efficient, and easy-to-use alternatives for phase I trials when the toxicity outcome is late-onset.

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http://dx.doi.org/10.1002/pst.2304DOI Listing

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