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| Main Authors: | , , , , |
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| Format: | Preprint |
| Published: |
2026
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| Subjects: | |
| Online Access: | https://arxiv.org/abs/2603.19403 |
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| _version_ | 1866918398921801728 |
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| author | Ge, Renee Y. Shohoudi, Azadeh Iyengar, Malini Li, Quefeng Li, Judy |
| author_facet | Ge, Renee Y. Shohoudi, Azadeh Iyengar, Malini Li, Quefeng Li, Judy |
| contents | Candidate binary endpoints are often considered as surrogates for time-to-event (TTE) clinical endpoints, primarily because they can be assessed at earlier time points. To be submitted for regulatory approval candidate binary endpoints need to validated. The most well-known method for performing such validation employs a meta-analytic framework to estimate individual-level and trial-level association. However, the performance of these association estimates in the context of a binary surrogate has not yet been examined through a comprehensive simulation study. This research aims to systematically investigate the performance of association estimates at the trial-level and at the individual-level under various trial design choices, using both simulation studies and clinical trial data, where available. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2603_19403 |
| institution | arXiv |
| publishDate | 2026 |
| record_format | arxiv |
| spellingShingle | Evaluation of Individual and Trial Level Association Metrics in the Validation of a Binary Surrogate Endpoint for a True Time-to-Event Endpoint Ge, Renee Y. Shohoudi, Azadeh Iyengar, Malini Li, Quefeng Li, Judy Applications Candidate binary endpoints are often considered as surrogates for time-to-event (TTE) clinical endpoints, primarily because they can be assessed at earlier time points. To be submitted for regulatory approval candidate binary endpoints need to validated. The most well-known method for performing such validation employs a meta-analytic framework to estimate individual-level and trial-level association. However, the performance of these association estimates in the context of a binary surrogate has not yet been examined through a comprehensive simulation study. This research aims to systematically investigate the performance of association estimates at the trial-level and at the individual-level under various trial design choices, using both simulation studies and clinical trial data, where available. |
| title | Evaluation of Individual and Trial Level Association Metrics in the Validation of a Binary Surrogate Endpoint for a True Time-to-Event Endpoint |
| topic | Applications |
| url | https://arxiv.org/abs/2603.19403 |