1. Bayesian Methods for Information Borrowing in Basket Trials: An Overview.
- Author
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Zhou, Tianjian and Ji, Yuan
- Subjects
TUMOR treatment ,STATISTICS ,EXPERIMENTAL design ,CLINICAL trials ,CLINICAL medicine research ,DATA analysis ,STATISTICAL models ,DRUG development ,PROBABILITY theory - Abstract
Simple Summary: This paper provides a review of statistical methods for tumor-agnostic clinical trials. In particular, the review focuses on basket trials and provides methodological insights into various Bayesian approaches. The key concept of borrowing information through Bayesian hierarchical models is emphasized, and some novel trial designs are introduced. The review is expected to provide oncology and biostatistics researchers with more exposure to powerful Bayesian methods for the design and analysis of tumor-agnostic clinical trials. Basket trials allow simultaneous evaluation of a single therapy across multiple cancer types or subtypes of the same cancer. Since the same treatment is tested across all baskets, it may be desirable to borrow information across them to improve the statistical precision and power in estimating and detecting the treatment effects in different baskets. We review recent developments in Bayesian methods for the design and analysis of basket trials, focusing on the mechanism of information borrowing. We explain the common components of these methods, such as a prior model for the treatment effects that embodies an assumption of exchangeability. We also discuss the distinct features of these methods that lead to different degrees of borrowing. Through simulation studies, we demonstrate the impact of information borrowing on the operating characteristics of these methods and discuss its broader implications for drug development. Examples of basket trials are presented in both phase I and phase II settings. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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