title: Model-based drug development in oncology: what's next?
abstract: Model-based estimates of tumor growth inhibition (TGI) metrics have the potential to enhance learning in early (phase II) clinical studies. They can be used as end points and biomarkers to predict treatment effect on clinical outcome measures-e.g., overall survival (OS)-and support phase II study design, end-of-phase II decisions, and phase III planning and execution. Efforts should be made to assess models in simulating independent studies with treatments of varying mechanisms of action.
authors.affiliation: Pharsight, A Certara Company, Marseille and Wintzenheim, France. rbruno@certara.com
authors.forename: R
authors.initials: R
authors.lastname: Bruno
authors.forename: F
authors.initials: F
authors.lastname: Mercier
authors.forename: L
authors.initials: L
authors.lastname: Claret
mesh_terms: D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D018450:Disease Progression; D007680:Kidney Neoplasms / Q000188:drug therapy*; D015233:Models, Statistical; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D000077157:Sorafenib
chemical_list: D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib