title: Models of excellence: improving oncology drug development.
abstract: Simulations based on disease-progression models and phase II trial results can predict phase III results and have the potential to improve oncology drug development by informing end-of-phase II decisions (EOP2Ds). Many barriers impede effective use of modeling and simulation (M&S) for EOP2Ds in oncology: concerns about model validity, lack of access to M&S results and patient-level data, limited awareness of M&S among academic oncologists, and inexperience fitting M&S into the drug development timeline.
authors.affiliation: Department of Medicine, University of Chicago, Illinois, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Sharma
authors.forename: M L
authors.initials: ML
authors.lastname: Maitland
authors.forename: M J
authors.initials: MJ
authors.lastname: Ratain
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003198:Computer Simulation; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008954:Models, Biological