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stat.ME2025
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…
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.ME2025
Harmonized Estimation of Subgroup-Specific Treatment Effects in Randomized Trials: The Use of External Control Data
Daniel Schwartz, Riddhiman Saha, Steffen Ventz +1
Subgroup analyses of randomized controlled trials (RCTs) constitute an important component of the drug development process in precision medicine. In particular, subgroup analyses o…