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Tuesday, June 26 • 2:00pm - 3:15pm
#266: User-Friendly Tools for Study Planning and Analysis

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will describe some novel tools for study planning an analysis. It will include use of open-source tools such as R and Shiny to plan, organize and execute the reporting of clinical trial data. Speakers will also show examples of self-service interactive visual tools that can be used during study design period.

Learning Objectives

Describe and demonstrate a novel report analysis plan process that uses using modern R/Shiny/Markdown technology to plan, execute and report clinical trial data; Identify examples of reusable self-service tools and show that they can help improve operational efficiency and communication.


Brenda Crowe, PhD


ShinyRAP: A Workflow for Analysis Planning, Organization, and Reporting Using Shiny
Xiao Ni, PhD

Empower Your Physicians and Enhance Communication Via Self-Service Tools
Rebeka Revis, MS

R Shiny Review Tools
Jonathon J. Vallejo, PhD

avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.

Xiao Ni

Group Head, Biostatistics, Novartis Institute for Biomdical Research
Xiao is a disease area lead statistician in early clinical development and an R/Shiny expert at Novartis. Through his 10-year career in pharma industry, Xiao has championed using visual analytic methods and tools (e.g. Shiny, Spotfire, JMP etc) in drug development. He received training... Read More →

Rebeka Revis

Statistician, Eli Lilly and Company
Rebeka Revis has been a statistical analyst at Eli Lilly and Company for 5 years. Her focus is primarily in safety visualizations. She uses Spotfire with R integration to create interactive visualizations for data reviews and provides internal training to people on how to create and... Read More →

Jonathon Vallejo

Mathematical Statistician, OB, OTS, CDER, FDA
Jonathon Vallejo is a statistical reviewer in the Office of Hematology and Oncology Products at FDA. He is the co-leader of the R Users group at FDA and has authored an R package for internal use at FDA. He is also active in the development and maintenance of Shiny apps at FDA.

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session