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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…
stat.ME2021
Approximating the Operating Characteristics of Bayesian Uncertainty Directed Trial Designs
Marta Bonsaglio, Sandra Fortini, Steffen Ventz +1
Bayesian response adaptive clinical trials are currently evaluating experimental therapies for several diseases. Adaptive decisions, such as pre-planned variations of the randomiza…