title: Graphical display of histopathology data from toxicology studies for drug discovery and development: An industry perspective.
abstract: Histopathology data comprise a critical component of pharmaceutical toxicology studies and are typically presented as finding incidence counts and severity scores per organ, and tabulated on multiple pages which can be challenging for review and aggregation of results. However, the SEND (Standard for Exchange of Nonclinical Data) standard provides a means for collecting and managing histopathology data in a uniform fashion which can allow informatics systems to archive, display and analyze data in novel ways. Various software applications have become available to convert histopathology data into graphical displays for analyses. A subgroup of the FDA-PhUSE Nonclinical Working Group conducted intra-industry surveys regarding the use of graphical displays of histopathology data. Visual cues, use-cases, the value of cross-domain and cross-study visualizations, and limitations were topics for discussion in the context of the surveys. The subgroup came to the following conclusions. Graphical displays appear advantageous as a communication tool to both pathologists and non-pathologists, and provide an efficient means for communicating pathology findings to project teams. Graphics can support hypothesis-generation which could include cross-domain interactive visualizations and/-or aggregating large datasets from multiple studies to observe and/or display patterns and trends. Incorporation of the SEND standard will provide a platform by which visualization tools will be able to aggregate, select and display information from complex and disparate datasets.
authors: Novartis Institutes for Biomedical Research, 100 Technology Square, Cambridge, MA 02139, USA. Electronic address: alan_p.brown@novartis.com.
authors: Alan P
authors: AP
authors: Brown
authors: PDS Consultants, Innovation Centre, 49 Oxford Street, Leicester, LE1 5XY England, UK.
authors: Philip
authors: P
authors: Drew
authors: Boehringer-Ingelheim, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
authors: Brian
authors: B
authors: Knight
authors: Novartis Institutes for Biomedical Research, Basel CH-4200, Switzerland.
authors: Philippe
authors: P
authors: Marc
authors: Merck & Co., Inc., WP81-404, Sumneytown Pike, West Point, PA 19486, USA.
authors: Sean
authors: S
authors: Troth
authors: Novartis Institutes for Biomedical Research, Basel CH-4200, Switzerland.
authors: Kuno
authors: K
authors: Wuersch
authors: Integrated Nonclinical Development Solutions (INDS) Incorporated, 6111 Jackson Road, Suite 100, Ann Arbor, MI 48103, USA.
authors: Joyce
authors: J
authors: Zandee
mesh_terms: D003142:Communication; D032882:Comprehension; D003196:Computer Graphics; D032921:Consensus; D003626:Data Display; D055808:Drug Discovery / Q000379:methods*; D004345:Drug Industry / Q000379:methods*; D006801:Humans; D010336:Pathology / Q000379:methods*; D018570:Risk Assessment; D012984:Software; D018675:Toxicity Tests / Q000379:methods*; D014796:Visual Perception
keywords: Graphics; Histopathology; Informatics; SEND; Toxicology