Group Response‐Adaptive Randomization With Delayed and Missing Responses

Response-adaptive randomization (RAR) procedures have been extensively studied in the literature, but most of the procedures rely on updating the randomization after each response, which is impractical in many clinical trials. In this article, we propose a new family of RAR procedures that dynamically update based on the responses of a group of individuals, either when available or at fixed time intervals (weekly or biweekly). We show that the proposed design retains the essential theoretical properties of Hu and Zhang's doubly adaptive biased coin designs (DBCD), and performs well in scenarios involving delayed and randomly missing responses. Numerical studies have been conducted to demonstrate that the new proposed group doubly adaptive biased coin design has similar properties to the Hu and Zhang's DBCDs in different situations. We also apply the new design to a real clinical trial, highlighting its advantages and practicality. Our findings open the door to studying the properties of other group response adaptive designs, such as urn models, and facilitate the application of response-adaptive randomized clinical trials in practice.

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Publication Details

Journal
Statistics in Medicine
Published
2024-09-16
DOI
https://doi.org/10.1002/sim.10220
Citations
3
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
2.13

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article

Group Response‐Adaptive Randomization With Delayed and Missing Responses

Zhang Li, Feifang Hu, Guannan Zhai, Yang Li
3 citations
Statistics in Medicine
Statistical Methods in Clinical Trials
2.13
article

Group Response‐Adaptive Randomization With Delayed and Missing Responses

Zhang Li, Feifang Hu, Guannan Zhai, Yang Li
article en
3 citations

Abstract

Response-adaptive randomization (RAR) procedures have been extensively studied in the literature, but most of the procedures rely on updating the randomization after each response, which is impractical in many clinical trials. In this article, we propose a new family of RAR procedures that dynamically update based on the responses of a group of individuals, either when available or at fixed time intervals (weekly or biweekly). We show that the proposed design retains the essential theoretical properties of Hu and Zhang's doubly adaptive biased coin designs (DBCD), and performs well in scenarios involving delayed and randomly missing responses. Numerical studies have been conducted to demonstrate that the new proposed group doubly adaptive biased coin design has similar properties to the Hu and Zhang's DBCDs in different situations. We also apply the new design to a real clinical trial, highlighting its advantages and practicality. Our findings open the door to studying the properties of other group response adaptive designs, such as urn models, and facilitate the application of response-adaptive randomized clinical trials in practice.

Statistics in MedicineVol. 43(27)
George Washington University (US), Zhejiang Gongshang University (CN), Zhejiang University (CN), Renmin University of China (CN)
National Natural Science Foundation of China
Openalex Percentile: Top 12%
Statistical Methods in Clinical Trials
2.13
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Group Response‐Adaptive Randomization With Delayed and Missing Responses — Zhang Li, Feifang Hu, et al. · Statistics in Medicine (2024) | TGRS Research Map | TGRS