Choosing Phase II Endpoints and Designs: Evaluating the possibilities
Cet article passe en revue les modèles mathématiques permettant de choisir les critères de jugement les plus adaptés dans les essais cliniques de phase II
Selecting the Phase II design and endpoint to achieve the best possible chance of success for a confirmatory Phase III study in a particular disease and treatment setting is challenging but critical. Simulating from existing clinical trial data sets, and mathematical models, can be useful tools for evaluating statistical properties.
Clinical Cancer Research , résumé, 2012