Bolon, Brad, Caverly Rae, Jessica, Colman, Karyn, Francke, Sabine, Jensen, Karl, Keane, Kevin, McInnes, Elizabeth F., Nakano-Ito, Kyoko, Perry, Rick, Polack, Evelyne, Reagan, Karen S., Romeike, Annette, 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