an automation proof of concept of periodic reporting via r ... · psur/dsur • periodic safety...
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Melinda, Tree of LifeMelinda’s artwork reflects her
journey living with HIV.
An Automation Proof of Concept of Periodic Reporting via R Shiny
Nicholas Masel (Analytics Innovation Technical Lead)Steven Haesendonckx (Senior Programmer Analyst - Statistical Programming, IDAR)Alexandra Papadopoulou (Programmer Analyst – Statistical Programming, IDAR)
September, 2019
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Disclaimer
Some of the opinions are personal and might not reflect the company’s view on things.
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AgendaR & Shiny
PSUR/DSUR as PoC
Shiny : Behind the scenes
PSUR/DSUR : The ins and outs
PSUR/DSUR : Flexibility
PSUR/DSUR: Demonstration
Fade out with Q&A
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R in Pharma• SAS: golden standard
• R: alternative to SAS
• Ongoing efforts from industry http://rinpharma.com/https://www.pharmar.org/
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Why R and shiny?
Large user baseActive community
Cutting edge statistical analysisExtensive graphical tool box
Easy to learn
R PackageBuild interactive websites
No knowledge of JS, HTML, ....requiredIdeal for interactive analysis and reporting
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Why R and shiny?
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PSUR/DSUR as a PoCPSUR/DSUR
• Periodic Safety Update Report – Development Safety Update Report
• Provided to authorities periodically
• Relatively simple safety report
• Pre-specified tables and listings generated
Automatization
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Shiny: Behind the scenes
Ø Source file needs to be created in R which defines:Ø UI(User Interface)Ø Server function
Ø UI:Ø Relevant code for layoutØ Embedded widgets
Ø Server function:Ø Translation of input to output
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Shiny: Behind the scenes
Source file in R which defines:• User Interface (UI)• Server function
UI:• Relevant code for layout• Embedded widgets
Server function:• Translation of input to output
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Shiny: Behind the sceneslibrary(shiny)
# Define UI for the applicationui <- fluidPage(
headerPanel("Hello Shiny!"))
# Define the server logicserver <- function(input, output) {}
# Run the applicationshinyApp(ui = ui, server = server)
input
output
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PSUR/DSUR: The ins and outs
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• Decreased complexity• Better readability of
source code
PSUR/DSUR: The ins and outs
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PSUR/DSUR: The ins and outs
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PSUR/DSUR: Flexibility
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PSUR/DSUR: Flexibility
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PSUR/DSUR: Flexibility
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demo
PSUR/DSUR: Demonstration
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Packages
Tidyverse• Data wrangling
Shiny• Interactive web pages• Visualization of results
Huxtable• HTML output for shiny UI• RTF output for download
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Future EnhancementsImprove on the UI/UX
Develop summary functions for complex outputs
Include interactive display mode of outputs
Include graphs
Validation• Accuracy, reproducibility, traceability • SOP of process, package selection, justification, unit testing• Docker containers and R Studio Package Manager for reproducibility
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Conclusion
R: easier to learn and cost-effective
R and Shiny: potential for interactive analysis and reporting
More key features are required for other reporting efforts
PSUR/DSUR PoC is a solid starting point for expansion
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§ Thank you
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Melinda, Tree of LifeMelinda’s artwork reflects her
journey living with HIV.
Thank you!
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