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Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial.

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Title: Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial.
Authors: Park, Yeonhee1 (AUTHOR) ypark56@wisc.edu
Source: Statistics in Biopharmaceutical Research. Oct-Dec2025, Vol. 17 Issue 4, p557-566. 10p.
Subjects: Clinical trials, Sequential analysis, Experimental design, T-test (Statistics), Simulation methods & models
Abstract: Surrogate endpoints are pivotal in clinical trials, replacing true endpoints that may be challenging to measure. However, their imprecise association with true endpoints can lead to biased results, necessitating validation through trials. This article proposes a bias-corrected group sequential design in the presence of surrogate endpoints to address these challenges. We introduce bias-corrected test statistics tailored to scenarios where both true and surrogate endpoints are available or where true endpoints are limited. Our approach is exemplified through a simulation study and a case study redesign of the Pamoja Tulinde Maisha (PALM) trial, showcasing its practical implementation and benefits. The proposed design enhances the accuracy of interim analyses by mitigating biases associated with surrogate endpoints. Through rigorous evaluation and comparison with alternative designs, we demonstrate the effectiveness of the proposed methods. [ABSTRACT FROM AUTHOR]
Copyright of Statistics in Biopharmaceutical Research is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial.
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  Data: Surrogate endpoints are pivotal in clinical trials, replacing true endpoints that may be challenging to measure. However, their imprecise association with true endpoints can lead to biased results, necessitating validation through trials. This article proposes a bias-corrected group sequential design in the presence of surrogate endpoints to address these challenges. We introduce bias-corrected test statistics tailored to scenarios where both true and surrogate endpoints are available or where true endpoints are limited. Our approach is exemplified through a simulation study and a case study redesign of the Pamoja Tulinde Maisha (PALM) trial, showcasing its practical implementation and benefits. The proposed design enhances the accuracy of interim analyses by mitigating biases associated with surrogate endpoints. Through rigorous evaluation and comparison with alternative designs, we demonstrate the effectiveness of the proposed methods. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Statistics in Biopharmaceutical Research is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1080/19466315.2024.2432906
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        Text: English
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      – SubjectFull: Clinical trials
        Type: general
      – SubjectFull: Sequential analysis
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      – SubjectFull: Experimental design
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      – SubjectFull: T-test (Statistics)
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      – SubjectFull: Simulation methods & models
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      – TitleFull: Bias-Corrected Group Sequential Design in the Presence of Surrogate Endpoints with Application to PALM Trial.
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              Text: Oct-Dec2025
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