title: Pathology working groups.
abstract: Pathology Working Groups (PWG) are a specialized form of review consisting of a panel of expert pathologists who provide an independent, unbiased assessment of specific questions concerning study results. PWGs may concentrate on pivotal studies with controversial end points, address questions that are of concern to a regulatory agency, or compare the results of multiple studies that may have been conducted and evaluated by different laboratories and/or pathologists. The PWG does not review the entire study but always includes a preliminary review by a peer review pathologist. The PWG chairperson needs to thoroughly understand the issue in question, reviews all relevant data and study results, and is responsible for the organization and conduct of the PWG. The members of the PWG examine coded slides without knowledge of treatment group or previous diagnosis and arrive at a consensus diagnosis by majority vote. Once the results are decoded, the PWG evaluates the results and provides discussion and conclusions that are reflected in the final PWG report. Specific examples of PWG issues are provided.
authors.affiliation: 1Experimental Pathology Laboratories Northwest, Seattle, Washington, USA.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Mann
authors.forename: Jerry H
authors.initials: JH
authors.lastname: Hardisty
mesh_terms: D004353:Drug Evaluation, Preclinical; D010336:Pathology / Q000592:standards*; D010380:Peer Review / Q000379:methods*; D018675:Toxicity Tests; D014116:Toxicology / Q000592:standards*
keywords: drug development; histopathology; preclinical safety assessment/risk management; regulatory affairs; risk assessment; risk identification; safety assessment.