RWDExchange

RWDExchange is a Shiny application designed to evaluate the exchangeability potential of your real-world data (RWD) including electronic health records and patient registries for use as external comparators in clinical trials.

Features

• Variable Assessment: Evaluate the basic variables.
• Pocock's Criteria: Assess the criteria for using historical controls.
• FDA Guidance: Follow the FDA guidelines for externally controlled trials.
• Download Report: Generate a comprehensive report of your assessments.
• How To: Instructions on how to use the RWDExchange app.
• OMOP Data Scan: The OMOP Data Scan feature is in development. It will allow for scanning OMOP-formatted data based on pre-scpecified concept codes that represent the variables identified in the other features of the app. Stay tuned for updates!

Installation and Usage

Prerequisites

Make sure you have R and RStudio installed. You also need to install the required packages:

install.packages(c("shiny", "devtools"))

Download and install Rtools from here.

Installation

You can install the RWDExchange package directly from GitHub:

devtools::install_github("BoyceLab/RWDExchange")

Running the App

Load the package and run the app with the following commands:

library(RWDExchange)
run_app()

User Guide

Step-by-Step Instructions

1. Variable Assessment:

   • Navigate to the "Variable Assessment" tab.
   • Enter the project name, clinical trial variable name, RWD variable name, and select the category.
   • Answer the questions about the variable's collection and availability.
   • Add notes as needed and click "Add Variable" to save the variable.

2. Pocock's Criteria:

   • Select a variable from the dropdown menu.
   • Evaluate each criterion and provide notes.
   • Click "Save Pocock Criteria" to save your evaluations.

3. FDA Guidance:

   • Select a variable from the dropdown menu.
   • Evaluate each criterion and provide notes.
   • Click "Save FDA Criteria" to save your evaluations.

4. Download Report:

   • Navigate to the "Download Report" tab.
   • Click "Generate CSV Report" to download a comprehensive report of your assessments.

License

This project is licensed under the MIT License - see the LICENSE file for details.

Reference:

• Gray CM, Grimson F, Layton D, Pocock S, Kim J. A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data. Drug Saf. 2020 Jul;43(7):623-633. doi: 10.1007/s40264-020-00944-1. PMID: 32440847; PMCID: PMC7305259.
• Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976 Mar;29(3):175-88. doi: 10.1016/0021-9681(76)90044-8. PMID: 770493.
• US Food and Drug Administration, "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products." February 2023. Link.

Contact

Developed by Danielle Boyce, MPH, DPA. For any questions or support, contact danielle@boycedatascience.com.