title: Biomarker use is associated with reduced clinical trial failure risk in metastatic melanoma.
abstract: Given the high morbidity and mortality associated with metastatic melanoma, considerable attention has been paid to identifying potential therapies. Until recently, few therapies have been specifically approved for treating metastatic melanoma. In an attempt to increase clinical trial successes, many therapies are implementing biomarkers for patient stratification. This strategy narrows down the population in an effort to identify appropriate subpopulations that have increased efficacy or fewer safety concerns. However, the addition of a biomarker constitutes an additional risk to clinical development and may therefore increase the overall clinical trial risk. Here, we examine the clinical trial success rate for therapies targeting metastatic melanoma. In addition, we identify the impact that biomarkers have had on the clinical development of this disease.
authors.affiliation: Biology Department, University of Toronto Mississauga, William Davis Building, Room 2071, Mississauga, ON, L5L 1C6, Canada.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Rubinger
authors.forename: Sarah S
authors.initials: SS
authors.lastname: Hollmann
authors.forename: Viktoria
authors.initials: V
authors.lastname: Serdetchnaia
authors.forename: D Scott
authors.initials: DS
authors.lastname: Ernst
authors.forename: Jayson L
authors.initials: JL
authors.lastname: Parker
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000378:metabolism*; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D006801:Humans; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D009362:Neoplasm Metastasis; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers
keywords: biomarker; clinical trial risk; drug approval; drug development; metastatic melanoma