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Toxicologic Pathology Forum Opinion Piece: Current Use of Non-blinded vs. Blinded Histopathologic Evaluation in Animal Toxicity Studies

Bolon, Brad and Caverly Rae, Jessica and Colman, Karyn and Francke, Sabine and Jensen, Karl and Keane, Kevin and McInnes, Elizabeth F. and Nakano-Ito, Kyoko and Perry, Rick and Polack, Evelyne and Reagan, Karen S. and Romeike, Annette and Young, Jamie K. and Galbreath, Elizabeth (2020) Toxicologic Pathology Forum Opinion Piece: Current Use of Non-blinded vs. Blinded Histopathologic Evaluation in Animal Toxicity Studies. Experimental and Toxicologic Pathology. ISSN 0192-62331533-1601

Abstract

The Society of Toxicologic Pathology (STP) explored current institutional practices for selecting between non-blinded vs. blinded histopathologic evaluation during Good Laboratory Practice (GLP)-compliant, regulatory-type animal toxicity studies using a multi-question survey and STP-wide discussion at the 2019 STP annual meeting. Survey responses were received from 107 individuals representing 87 institutions that collectively employ 589 toxicologic pathologists. Most responses came from industry (N = 46, mainly biopharmaceutical or contract research organizations) and consultants (N = 24). For GLP-compliant animal toxicity studies, histopathologic evaluation usually involves initial (primary) non-blinded analysis, with post hoc informal blinded re-examination at the study pathologist’s discretion to confirm subtle findings or establish thresholds. Initial blinded histopathologic evaluation sometimes is elected by study pathologists to test formal hypotheses and/or by sponsors to address non-pathologist expectations about histopathology data objectivity. Current practice is that a blinded histopathologic evaluation is documented only if a formal blinding (i.e., using slides with coded labels) is employed, using simple statements without detailed methodology in the Study Protocol (or an amendment) and/or pathology report. In general, blinding is an inappropriate strategy for the histopathologic evaluation during pathology peer reviews of GLP-compliant animal toxicity studies.

Item Type: Article
Keywords: blinded evaluation, non-blinded evaluation, GLP, histopathology, nonclinical toxicity study
Date Deposited: 13 May 2020 00:45
Last Modified: 13 May 2020 00:45
URI: https://oak.novartis.com/id/eprint/41924

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