title: [Phases 0, 1 and 2 oncology clinical trials: current questions].
abstract: We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.
authors.affiliation: Centre Oscar-Lambret, Département de Cancérologie Générale, 3 Rue Frédéric-Combemale, 59000 Lille, France. n-penel@o-lambret.fr
authors.forename: N
authors.initials: N
authors.lastname: Penel
authors.forename: C
authors.initials: C
authors.lastname: Fournier
authors.forename: C
authors.initials: C
authors.lastname: Stéphanie
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D017321:Clinical Trials, Phase I as Topic / Q000379:methods / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000592:standards; D003662:Decision Theory; D004354:Drug Screening Assays, Antitumor / Q000379:methods / Q000592:standards; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents