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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/2604.03863 |
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Table of Contents:
- The estimand framework provides guidance on handling intercurrent events, such as treatment discontinuation, in the analysis of clinical trial responses. Under ICH E9(R1), the treatment policy (TP) strategy incorporates post-discontinuation data to reflect treatment effects in real-world practice. However, many existing approaches focus primarily on imputing missing endpoint values for lost-to-follow-up subjects and do not explicitly model completers, retrieved dropouts (RDs), and lost-to-follow-up subjects within a unified framework. This may obscure the relationship between modeling assumptions and the estimand of interest when RD data are present. We propose a likelihood-based model for continuous endpoints that integrates data from all subject categories, including RDs. The approach combines an analysis of covariance formulation with a probit model for treatment discontinuation, enabling explicit formulation of treatment effects for estimands defined using the hypothetical and TP strategies. Estimation is carried out via a computationally efficient maximum likelihood procedure. Numerical studies demonstrate that the proposed method achieves improved bias and variability properties compared with commonly used imputation-based approaches.