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stat.ME2026
Q-approximation of operating characteristics of clinical trial designs
Susanna Gentile, Daniel E. Schwartz, Riddhiman Saha +1
Designing clinical trials requires evaluating multiple operating characteristics (OCs), such as the likelihood of an early stopping decision, the probability of detecting a treatme…
stat.ME2025
Leveraging External Data for Testing Experimental Therapies with Biomarker Interactions in Randomized Clinical Trials
Boyu Ren, Federico Ferrari, Sandra Fortini +2
In oncology the efficacy of novel therapeutics often differs across patient subgroups, and these variations are difficult to predict during the initial phases of the drug developme…
stat.ME2024
Leveraging external data in the analysis of randomized controlled trials: a comparative analysis
Gopal Kotecha, Daniel E. Schwartz, Steffen Ventz +1
The use of patient-level information from previous studies, registries, and other external datasets can support the analysis of single-arm and randomized controlled trials to evalu…