A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
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.
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Foundation for National Institutes of Health, Washington, DC, USA.
Amakye
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Bounos
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Bloom
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Clack
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Dean
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R
Devanarayan
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Fu
D
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Furlong
S
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Hinman
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Girman
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Lathia
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Lesko
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Madani
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Mayne
J
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Meyer
J
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Raunig
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Sager
P
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Williams
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Wong
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Zerba
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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
D015415:Biomarkers; D054316:Biomarkers, Pharmacological