ArticleContemporary clinical trials communications2020
A model-based approach for simulating adaptive clinical studies with surrogate endpoints used for interim decision-making.
Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- A practical guide to simulation for an adaptive trial design with a single interim analysis.Trials · 2025Article
- Using a surrogate with heterogeneous utility to test for a treatment effect.Statistics in medicine · 2023Article
- Estimation of the proportion of treatment effect explained by a high-dimensional surrogate.Statistics in medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In clinical trials, when exploring multiple dose groups to establish efficacy and safety on one or more selected doses, adaptive designs with interim dose selection are often used for dropping less effective dose groups. When it takes a long time to observe primary outcomes, utilizing information on a surrogate endpoint available at an earlier interim may be preferred for selecting which dose to continue. We propose a Bayesian model-based approach where historical data can be leveraged to incorporate a correlation model for investigating the design's operating characteristics. Simulation studies were conducted and the method can be readily applied for power and sample size calculations.
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