title: Regulatory Forum Opinion Piece: Blinding and Binning in Histopathology Methods in the Biomarker Qualification Process.
abstract: Both, the Society of Toxicologic Pathology (STP) and the U.S. Food and Drug Administration (FDA) have released documents discussing histopathology methods in biomarker qualification studies. These documents appear to disagree on two critical and controversial aspects of methodology; blinding of pathologists and binning of data (Burkhardt et al. 2011; U.S. FDA 2011). Upon closer examination, however, both documents propose that blinded evaluation of biomarker studies is appropriate under similar strict criteria. However, they differ in their recommendations on the binning of data (i.e., individual binning of all changes vs. common binning of changes observed in control animals), seemingly based on different perceptions of study objectives and the role of the pathologist. This article offers a personal opinion on blinded evaluations and data binning in the context of biomarker qualification studies.
authors.affiliation: Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA rodney.rouse@fda.hhs.gov.
authors.forename: Rodney
authors.initials: R
authors.lastname: Rouse
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis / Q000737:chemistry*; D003627:Data Interpretation, Statistical; D006801:Humans; D012016:Reference Values; D014116:Toxicology / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers
keywords: biomarker assessment; biomarker qualification; blinded evaluations; data binning or filtering.; histopathology methods; knowledge bias