Comparison Among Modified Continual Reassessment Methods with Different Dose Allocation Methods for Phase I Clinical Trials

Jiacheng Xiao, Weijia Zhang, Rong Li () and Conghua Wen ()
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Jiacheng Xiao: Department of Financial and Actuarial Mathematics, Xi’an Jiaotong-Liverpool University, Suzhou 215123, China
Weijia Zhang: Department of Financial and Actuarial Mathematics, Xi’an Jiaotong-Liverpool University, Suzhou 215123, China
Rong Li: Department of Financial and Actuarial Mathematics, Xi’an Jiaotong-Liverpool University, Suzhou 215123, China
Conghua Wen: Department of Financial and Actuarial Mathematics, Xi’an Jiaotong-Liverpool University, Suzhou 215123, China

Mathematics, 2025, vol. 13, issue 5, 1-18

Abstract: The continual reassessment method (CRM) has been an essential Bayesian finding design in phase I clinical trials. It utilizes all the information in observed data which contributes to its essential operational characteristics. However, the CRM has been criticized for its aggressive dose escalation. Model-assisted methods including BOIN, Keyboard, and mTPI improved the safety while retaining relative efficiency. In this paper, we propose four models combining the structure of the CRM and model-assisted methods. We show that these models could operate with comparable CRM performance through simulations. The results suggest that two of the proposed methods outperformed the traditional methods with a higher percentage of correct selection of true maximum tolerated dose. In addition, the interval-based approaches offered by the new models with greater flexibility regarding target toxicity achieved an improvement in the adaptability of the dose-finding process in clinical trials.

Keywords: clinical trial; biostatistics; CRM; Bayesian adaptive design (search for similar items in EconPapers)
JEL-codes: C (search for similar items in EconPapers)
Date: 2025
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