RWDExchange

Live site → boyceLab.github.io/RWDExchange
Demo → boyceLab.github.io/RWDExchange/demo.html

RWDExchange is a browser-based tool for evaluating the exchangeability potential of real-world data (RWD) — including electronic health records and patient registries — for use as external comparators in clinical trials.

No installation, no server, no login. All assessment data is stored locally in your browser.

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Features

• Variable Assessment — Structured six-question exchangeability scoring (0–6); optional data quality metrics and confounder documentation
• Pocock's Criteria — Seven criteria for acceptable historical controls (Pocock, 1976)
• FDA Guidance — Eight considerations from the FDA 2023 externally controlled trials guidance
• Gray et al. Framework — Eight methodological domains (Gray et al., Drug Saf. 2020)
• Composite Verdict — Weighted synthesis across all four frameworks with live progress ring
• Progress Tracking — Per-variable POC · FDA · GRY completion pills
• Export — CSV (per-framework or combined) and JSON backup/restore
• Shareable URL — Full session encoded in URL hash for easy sharing
• Print View — Clean print stylesheet for regulatory appendices
• Demo Mode — demo.html pre-loaded with synthetic ALS external comparator data

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Deployment

GitHub Pages (recommended)

1. Copy index.html, demo.html, and .nojekyll to the root of this repository on the main branch
2. Go to Settings → Pages → Source → select main branch, / (root)
3. Site will be live at https://boyceLab.github.io/RWDExchange/ within ~2 minutes

Local use

Open index.html in any modern browser. No server needed.

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Files

File	Purpose
index.html	Main application — clean workspace, your own data
demo.html	Pre-loaded with synthetic ALS trial data for exploration
.nojekyll	Prevents GitHub Pages from running Jekyll on these files

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Data & Privacy

All data is stored exclusively in your browser's localStorage. Nothing is transmitted to any server. index.html and demo.html use separate storage namespaces so demo data never interferes with your real assessments.

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References

• 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;43(7):623-633. doi: 10.1007/s40264-020-00944-1
• Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976;29(3):175-88. doi: 10.1016/0021-9681(76)90044-8
• US Food and Drug Administration. "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products." February 2023.

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Developed by Danielle Boyce, MPH, DPA · danielle@boycedatascience.com · MIT License