title: Drug-diagnostic co-development: challenges and issues.
abstract: Diagnostic tests have become increasingly important for optimizing drug use. Ideally, a companion diagnostic test is developed concurrently with a corresponding therapeutic product (co-development). However, the diagnostic test may also be developed to optimize treatment with previously approved therapeutic agents (follow-up-development). In co-development, the effectiveness of an agent in marker-defined patients is confirmed by an enrichment trial design. In follow-up-development, a biomarker is validated by prospective and/or retrospective analyses of unselected design trials. A prospectively designed trial is the gold-standard approach to biomarker validation, but retrospective validation can be used to efficiently determine effective treatments for marker-defined patients. Accumulation and systematization of examples of drug-diagnostic development will aid in the effective development of companion diagnostics.
authors.affiliation: a Graduate School of Medicine , Osaka University , Osaka , Japan.
authors.forename: Rumiko
authors.initials: R
authors.lastname: Shimazawa
authors.affiliation: b Department of Medical Informatics , Kagawa University Hospital , Kagawa , Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ikeda
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000737:chemistry* / Q000494:pharmacology; D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism*; D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000379:methods* / Q000639:trends; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000639:trends; D011933:Reagent Kits, Diagnostic; D054928:Validation Studies as Topic
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic
keywords: Companion diagnostic; bridging study; class effect; co-development; drug development process; drug–diagnostic development; follow-up-development; predictive biomarker; retrospective validation