Interactive safety review with Spotfire - PhUSE · Interactive safety review with Spotfire Code...
Transcript of Interactive safety review with Spotfire - PhUSE · Interactive safety review with Spotfire Code...
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Interactive safety review with SpotfireCode Sharing Utilizing GitHub Workshop
PhUSE CSS 2017Rebeka Revis & Wei WangEli Lilly & Company
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Disclaimer for Spotfire safety review package
• There is currently no guidance on interactive displays from regulatory or the PhUSE Analysis and Display Whitepaper (ADW) Project Team
• We don’t recommend to create these displays instead of the recommended ones by ADW or in sponsor’s standards library
• Updates/modifications will be needed when the package is adopted for a study
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Why interactive visuals?
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Interactive Visualizations at Lilly• Data Review and Exploration• Generating Static Reports included for study reports, submission documents, regulatory response documents.
• Advisory board meeting• Data mining and publication efforts• Other
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What is Spotfire?• A tool that allows users to create interactive visuals• Interact across visuals, datasets, and pages• Can integrate other scripts from programs such as R and Python
• Two types of accounts– Professional: Creates the visuals– Webplayer: Can view and interact with visuals through a web browser
• A company needs to set‐up a server
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Where to find the Spotfire file?• Uploaded to GitHub as a DXP file
– https://github.com/phuse‐org/phuse‐scripts/tree/master/contributed/Spotfire
–DXP file contains:• Embedded de‐identified ADaM data
– Original data files: https://github.com/phuse‐org/phuse‐scripts/tree/master/data/adam/cdisc
• Multiple pages with interactive visualizations for safety analyses
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Cautions when using interactive visuals?• How to validate?
– Procedures to validate interactive visuals
• Design challenges– Use good graphic principles
• Just because you can do it doesn’t mean you should• Principles still applied with interactive visuals
– Use of interactive features• Designing interactive visuals should put the customer experience first• How does interacting with one visual affect the rest of the package?
• Working model shift– Team collaboration greatly increases with interactive visuals
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SpotfireDemo
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Back-up slides(static version of interactive demo)
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Overview of Patient Level Safety Data
Choose the patient of interest and the display will be updated.
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Adverse Event Data in Connection of Lab Data Review
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Drop down to choose the MedDRA Hierarchy for the AE terms. See how the y axis of the bar chart changes as the drop down selection changes.
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Zoom slider can be turned on to get a zoomed in look at the plot.
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Choose an AE of interest and have all the lab information for those patients reporting that AE show up. Users can choose which labs they would like to show. Note: in this case, only one patient reported ‘Hyperbilirubineamia’.
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Event Density and Onset
More adverse events and happens earlier during the treated period. There is a dose relationship –high dose has even more AE than lower dose.
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Drop down list for subgroup analysis
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AE Summary Based on SMQs
Choose SMQ(s)
Define scope
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Safety for Patients Met a Lab Threshold
Define Threshold
Over time measures for patients ever met the threshold
Adverse Events for those whose lab measures met the threshold.
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Max. Bili vs Max. ALT
Mark the dot of interest
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‘Patient Profile Page’ is synchronized to the patient selected in the previous page.