Precision generalized phase I-II designs.

ABSTRACT: A new family of precision Bayesian dose optimization designs, PGen I-II, based on early efficacy, early toxicity, and long-term time to treatment failure is proposed. A PGen I-II design refines a Gen I-II design by accounting for patient heterogeneity characterized by subgroups that may be defined by prognostic levels, disease subtypes, or biomarker categories. The design makes subgroup-specific decisions, which may be to drop an unacceptably toxic or inefficacious dose, randomize patients among acceptable doses, or identify a best dose in terms of treatment success defined in terms of time to failure over long-term follow-up. A piecewise exponential distribution for failure time is assumed, including subgroup-specific effects of dose, response, and toxicity. Latent variables are used to a

SUBMITTER: Zhao S 

PROVIDER: S-EPMC12288667 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature