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Project Scope Histopathology data comprise a major component of toxicology s= tudies and are typically presented in data tables (tabular format) in study= reports. Can these data be graphically displayed in a visual format which = provides a means for rapidly identifying and communicating treatment group = differences, patterns in response, and/or changes in phenotypic expression&= nbsp;? Can cross-domain analyses (including organ weights, clinical patholo= gy and histopathology data) be graphically displayed for analyses ? Ca= n data from multiple studies be aggregated or graphically displayed for ana= lysis ? How does incorporation of the SEND (Standard for Exchange of N= onclinical Data) standard enable this technology? To canvas opinion from toxicologists, pathologis= ts, bioinformatics specialists and software designers on current methods of= data visualization and how those might be improved or expanded to improve = data analyses compared to currently used tabular (incidence) formats. To co= mmunicate points of discussion, ideas, case examples, etc. with key stake h= olders (the pharmaceutical industry, software developers/vendors, CROs, US = FDA) via the Advance Hub, poster presentations and publications. = |
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Vision |
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To explore= the use of various software applications for visually displaying histopath= ology data in novel ways to aid with data analysis and communication of fin= dings, and to promote the use of the SEND standard for enabling this techno= logy |
Prior Project Plans |
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The projec=
t completed its third year of activity (2017 to 2018). Project plans includ=
ed the following. 1) Evalua= te the use of the "sunburst" graphical display (termed HistoGraphic) and ap= plication for visualizing histopathology data from the = span>IMI eTOX database 3) Explore use of the "sunburst" (HistoGraph= ic) application for simultaneously displaying microscopic findings and rele= vant biomarkers. As an example, initial efforts can focus on liver lesions = and serum ALT, AST, ALKP and/or bilirubin changes 3) Collaborate with the Nonclinical Scripts working = group for development and evaluation of novel software applications, such a= s HistoGraphic, for data visualization. The first two projects listed above= are a component of this activity 4) Create mock SEND datasets of histopathology data for incorporatio= n into various software applications to evaluate multi-study data displays<= /span> |
Summary of Projects |
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After 3 ye= ars of activity, the project has reached a natural conclusion with developm= ent of HistoGraphic for graphically displaying histopathology data from mul= tiple toxicology studies which were obtained from the European Union's IMI = eTOX database. Deliverables from the project team included 3 posters presen= ted at FDA PHUSE CSS meetings and one publication. It is the project team's= intent to place HistoGraphic on a publicly assessed site for downloading. = Following completion of this project, a new project has been endorsed by PH= USE for initiation in 2018: Data Visualization as an Enabler for Nonclinica= l Safety Signal Detection. This project will include a collaborative relati= onship with the EU's IMI eTRANSAFE initiative (Enhancing Translational Safe= ty Assessment through Integrative Knowledge Management) <= /span>eTRANSAFE. |
Milestones |
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March 2015 - March 2016 (completed)= strong> 1) Identify a panel of Toxicologists and Pathologists (2 week=
s) April 2016 - March 2017 (completed) 1) Prepare first draft of manuscript (July 2016) - completed April 2017 - March 2018 (completed) 1) Obtain eTOX =
datasets and incorporate into HistoGraphic display tool (completed November=
2017) |
Data Visualisation Examples |
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Tasks |
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Upcoming milestones for 2018 FDA PHUSE Comput= ational Sciences Symposium, 4-6 March 2018 in Silver Spring, Maryland, USA:=
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Deliverables for 2015 |
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Deliverables for 2016 |
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Publication in Regulatory Toxicology and Phar= macology Poster presented at 2017 FDA PHUSE Computational Sciences Symposium= |