title: Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?
abstract: Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
authors: Drug Development Unit, Royal Marsden Hospital, Marsden Hospital, Sutton, Surrey SM2 5PT, UK.
authors: Craig P
authors: CP
authors: Carden
authors: Debashis
authors: D
authors: Sarker
authors: Sophie
authors: S
authors: Postel-Vinay
authors: Timothy A
authors: TA
authors: Yap
authors: Gerthardt
authors: G
authors: Attard
authors: Udai
authors: U
authors: Banerji
authors: Michelle D
authors: MD
authors: Garrett
authors: George V
authors: GV
authors: Thomas
authors: Paul
authors: P
authors: Workman
authors: Stan B
authors: SB
authors: Kaye
authors: Johann S
authors: JS
authors: de Bono
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D054316:Biomarkers, Pharmacological / Q000032:analysis*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D017277:Drug Approval; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008954:Models, Biological; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D010597:Pharmacogenetics
chemical_list: D000970:Antineoplastic Agents; D054316:Biomarkers, Pharmacological