4 papers
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…
A cautious use of auxiliary outcomes for decision-making in randomized clinical trials
Massimiliano Russo, Steffen Ventz, Lorenzo Trippa
Clinical trials often collect data on multiple outcomes, such as overall survival (OS), progression-free survival (PFS), and response to treatment (RT). In most cases, however, stu…
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…
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…