Step 1 of 4
Variable Assessment
Evaluate each candidate variable with six structured exchangeability questions. Add data quality metrics and confounders using the collapsible sections below.
Step 2 of 4
Pocock's Criteria
Evaluate the seven criteria for acceptable use of historical controls (Pocock, 1976).
Reference: 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
Step 3 of 4
FDA Guidance Assessment
Evaluate alignment with the FDA 2023 guidance on externally controlled trials.
Reference: US FDA. "Considerations for the Design and Conduct of Externally Controlled Trials." February 2023. View guidance ↗
Step 4 of 4
Gray et al. Framework
Eight methodological domains for evidence assessment in studies using external comparators from real-world data.
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;43(7):623-633. doi: 10.1007/s40264-020-00944-1
Export & Summary
Assessment Report
Download individual sections or the full combined report. JSON export preserves all data for re-import or sharing.
User Guide
How To Use RWDExchange
RWDExchange provides a structured, multi-framework assessment of whether real-world data can serve as a reliable external comparator in a clinical trial. It implements four complementary frameworks: a variable-level feasibility score, Pocock's seven historical control criteria, FDA 2023 guidance for externally controlled trials, and the Gray et al. (2020) methodological framework — synthesized into a single composite verdict per variable.
All data is stored in your browser via localStorage. Use Export JSON to back up and Share to generate a shareable URL. Try demo.html to see the tool pre-loaded with synthetic data.
Variable Assessment
Add each variable. Answer six exchangeability questions for a 0–6 score. Optionally add data quality metrics (N, % missing, date range) and planned confounders.
Pocock's Criteria
Rate each of the seven Pocock criteria. The composite verdict ring updates live as you save.
FDA Guidance
Rate alignment with each of the eight 2023 FDA considerations.
Gray et al. Framework
Complete the eight methodological domain assessment covering research question fit, population representativeness, confounders, analytical approach, and reproducibility.
Report & Export
View composite verdicts and download CSV or JSON exports. Use Share to generate a URL encoding your full session.
Variable is well-suited as an external comparator. Proceed to study design.
Usable with documented caveats and sensitivity analyses.
Significant limitations. Consider excluding or flagging as a major uncertainty.
Variable score only. Complete all three frameworks for a full verdict.
In Development
OMOP Data Scan
Coming Soon
The OMOP Data Scan will scan OMOP CDM–formatted data using pre-specified concept codes representing the variables assessed in the other modules, enabling automated standardized data characterization for external comparator feasibility.
BETA · IN DEVELOPMENTContact: danielle@boycedatascience.com