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| Autores principales: | , |
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| Formato: | Preprint |
| Publicado: |
2026
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| Materias: | |
| Acceso en línea: | https://arxiv.org/abs/2603.28615 |
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| _version_ | 1866910085769330688 |
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| author | Wang, Yu Szabo, Aniko |
| author_facet | Wang, Yu Szabo, Aniko |
| contents | Toxicity monitoring is essential in Phase II clinical trials to ensure participant safety. While monitoring rules are well-established for single-arm trials, two-cohort trials present unique challenges because toxicities are expected to be similar between cohorts but may still differ. Current approaches either monitor the two cohorts independently, which ignores their similarity, or pool them together as a single arm, which neglects heterogeneity between cohorts. We propose a Bayesian method based on a bivariate beta prior that provides a compromise between these two approaches. The marginal posterior distribution is derived as a mixture of beta distributions, enabling exact calculations of the proposed method's operating characteristics. Examples demonstrate that joint monitoring offers a balanced approach between the independent and pooled methods.
Keywords: Toxicity; Two-cohort; Phase II clinical trial; Monitoring rules; Bivariate Beta; Exact Operating characteristics |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2603_28615 |
| institution | arXiv |
| publishDate | 2026 |
| record_format | arxiv |
| spellingShingle | Toxicity Monitoring Rule for a Two-Cohort Phase II Clinical Trial with Bivariate Beta Prior Wang, Yu Szabo, Aniko Methodology Toxicity monitoring is essential in Phase II clinical trials to ensure participant safety. While monitoring rules are well-established for single-arm trials, two-cohort trials present unique challenges because toxicities are expected to be similar between cohorts but may still differ. Current approaches either monitor the two cohorts independently, which ignores their similarity, or pool them together as a single arm, which neglects heterogeneity between cohorts. We propose a Bayesian method based on a bivariate beta prior that provides a compromise between these two approaches. The marginal posterior distribution is derived as a mixture of beta distributions, enabling exact calculations of the proposed method's operating characteristics. Examples demonstrate that joint monitoring offers a balanced approach between the independent and pooled methods. Keywords: Toxicity; Two-cohort; Phase II clinical trial; Monitoring rules; Bivariate Beta; Exact Operating characteristics |
| title | Toxicity Monitoring Rule for a Two-Cohort Phase II Clinical Trial with Bivariate Beta Prior |
| topic | Methodology |
| url | https://arxiv.org/abs/2603.28615 |