Regulatory Forum Opinion Piece: Blinding and Binning in Histopathology Methods in the Biomarker Qualification Process

Toxicologic Pathology
Rodney Rouse

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.

References

Jan 10, 2004·Toxicologic Pathology·James W CrissmanDaryl C Thake
Sep 1, 2011·Expert Opinion on Medical Diagnostics·Janet WoodcockIssam Zineh

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Citations

Mar 24, 2018·Therapeutic Innovation & Regulatory Science·Rodney RouseDavid G Strauss
Mar 1, 2018·Therapeutic Innovation & Regulatory Science·Rodney RouseDavid G Strauss

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