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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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Table of 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.