title: Regulatory forum opinion piece: blind reading of histopathology slides in general toxicology studies.
abstract: With the intention of reducing bias, a recent European Food Safety Authority draft guidance document included a recommendation for blinded evaluation of histopathology slides in general toxicology studies (EFSA 2011). Although blinding as to treatment status reduces bias in many types of scientific experiment and is sometimes also appropriate in toxicologic pathology (Holland and Holland 2011), it is most unlikely to help achieve the overall goal of improved human safety when used for routine histopathology evaluation of tissues in general toxicology studies. This is the case because (1) blinding is not applicable to the inductive reasoning process used to identify test article effects in the tissues and would dramatically reduce the chances of these being successfully identified; and (2) in any case, the bias that would be reduced by blinding is actually a bias favoring diagnosis of a toxicological hazard and a conservative safety evaluation, which is appropriate in this context. Other unintended consequences of blinding histopathology evaluation include reductions in sensitivity for a variety of additional reasons and increased subjectivity of the pathology data.
authors.affiliation: Bristol Myers Squibb, New Brunswick, New Jersey 08901, USA. roy.l.kerlin@pfizer.com
authors.forename: Natasha
authors.initials: N
authors.lastname: Neef
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Nikula
authors.forename: Sabine
authors.initials: S
authors.lastname: Francke-Carroll
authors.forename: Laura
authors.initials: L
authors.lastname: Boone
mesh_terms: D015982:Bias; D006653:Histology / Q000592:standards*; D006801:Humans; D010336:Pathology / Q000379:methods / Q000592:standards*; D012107:Research Design; D018570:Risk Assessment; D014116:Toxicology / Q000379:methods / Q000592:standards*