arXiv subjects

Hengjia Fang

Publications and source records attributed to Hengjia Fang.

2 recordsLinked to original sources

arXiv2026

CBARA: Covariate-Balanced-and-Adjusted Response-Adaptive Randomization

We propose the covariate-balanced-and-adjusted response-adaptive randomization (CBARA) procedure for adaptive design in clinical trials, which integrates the complementary strengths of covariate-adjusted response-adaptive randomization (CARA) and covariate-adaptive randomization (CAR). The CBARA procedure updates the target allocation ratio according to observed responses and patient covariate profiles without requiring a correctly specified model, thereby retaining CARA's ethical and efficiency considerations while improving robustness. In addition, the CBARA procedure extends the CAR principle from fixed target allocation ratios to covariate-adjusted adaptive target allocation ratios, yet still pursues balance in treatment allocation with respect to covariate features. This integration is enabled by a newly defined imbalance vector and three interrelated components: the allocation function, parameter estimation and update mechanism. We establish the asymptotic properties of covariate imbalance and the estimators under the CBARA procedure. The results demonstrate that the CBARA procedure can improve balance for both observed and unobserved covariates while preserving the consistency of the allocation ratio. The theoretical analysis is developed through a pseudo-Markov chain framework, where a new discrepancy measure for transition kernels is introduced to handle the continuity of Poisson equation solutions with respect to parameters.

stat.ME↗

arXiv2026

A General (Non-Markovian) Framework for Covariate Adaptive Randomization: Achieving Balance While Eliminating the Shift

Emerging applications increasingly demand flexible covariate adaptive randomization (CAR) methods that support unequal targeted allocation ratios. While existing procedures can achieve covariate balance, they often suffer from the shift problem. This occurs when the allocation ratios of some additional covariates deviate from the target. We show that this problem is equivalent to a mismatch between the conditional average allocation ratio and the target among units sharing specific covariate values, revealing a failure of existing procedures in the long run. To address it, we derive a new form of allocation function by requiring that balancing covariates ensures the ratio matches the target. Based on this form, we design a class of parameterized allocation functions. When the parameter roughly matches certain characteristics of the covariate distribution, the resulting procedure can balance covariates. Thus, we propose a feasible randomization procedure that updates the parameter based on collected covariate information, rendering the procedure non-Markovian. To accommodate this, we introduce a CAR framework that allows non-Markovian procedure. We then establish its key theoretical properties, including the boundedness of covariate imbalance in probability and the asymptotic distribution of the imbalance for additional covariates. Ultimately, we conclude that the feasible randomization procedure can achieve covariate balance and eliminate the shift.

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