title: A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
abstract: A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.
authors: Foundation for National Institutes of Health, Washington, DC, USA.
authors: C A
authors: CA
authors: Altar
authors: D
authors: D
authors: Amakye
authors: D
authors: D
authors: Bounos
authors: J
authors: J
authors: Bloom
authors: G
authors: G
authors: Clack
authors: R
authors: R
authors: Dean
authors: V
authors: V
authors: Devanarayan
authors: D
authors: D
authors: Fu
authors: S
authors: S
authors: Furlong
authors: L
authors: L
authors: Hinman
authors: C
authors: C
authors: Girman
authors: C
authors: C
authors: Lathia
authors: L
authors: L
authors: Lesko
authors: S
authors: S
authors: Madani
authors: J
authors: J
authors: Mayne
authors: J
authors: J
authors: Meyer
authors: D
authors: D
authors: Raunig
authors: P
authors: P
authors: Sager
authors: S A
authors: SA
authors: Williams
authors: P
authors: P
authors: Wong
authors: K
authors: K
authors: Zerba
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D054316:Biomarkers, Pharmacological / Q000032:analysis*; D002986:Clinical Trials as Topic / Q000592:standards*; D003299:Cooperative Behavior; D003955:Diagnostic Tests, Routine / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D004345:Drug Industry; D006801:Humans; D016730:Program Development; D011786:Quality Control; D015203:Reproducibility of Results; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers; D054316:Biomarkers, Pharmacological