RWDExchange

Step 1 of 4 · Demo

Variable Assessment

This demo shows five variables from a hypothetical PRO-ACT registry external comparator analysis. Two variables are fully assessed across all three frameworks; the others are at various stages to illustrate the workflow.

Assessed Variables

#	Trial Variable	RWD Variable	Category	Score	Progress	Verdict

Step 2 of 4

Pocock's Criteria

The first two variables have pre-filled Pocock evaluations. Select each to explore the ratings and notes.

Reference: Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976;29(3):175-88.

Select Variable

Variable to Evaluate

Step 3 of 4

FDA Guidance Assessment

Variables 1 and 3 have FDA evaluations loaded. Note how Variable 3 (VC% Predicted) shows several "Not Aligned" ratings due to measurement and completeness issues.

Reference: US FDA. "Considerations for the Design and Conduct of Externally Controlled Trials." February 2023. View guidance ↗

Select Variable

Variable to Evaluate

Step 4 of 4

Gray et al. Framework

Variables 1 and 2 have full Gray et al. evaluations. Variable 1 shows an "Adequate with Limitations" on confounders due to missing FVC% data.

Reference: Gray CM et al. A Framework for Methodological Choice and Evidence Assessment. Drug Saf. 2020;43(7):623-633.

Select Variable

Variable to Evaluate

Export & Summary · Demo

Assessment Report

Variables

Strong Potential

Conditional

Limited Potential

Fully Assessed

Composite Verdicts

Export Demo Data

Download the synthetic demo data as CSV or JSON to explore the export format.

About This Demo

Demo Walkthrough

Scenario

This demo illustrates a hypothetical assessment of the PRO-ACT Registry as an external comparator for a Phase 3 ALS trial. Five candidate variables are evaluated across Pocock, FDA, and Gray et al. frameworks.

The data is entirely synthetic and illustrative. It is designed to demonstrate the range of outcomes the tool can surface — from Strong Potential (ALSFRS-R Total Score) to Limited Potential (Vital Capacity % Predicted).

Demo Variables Summary

ALSFRS-R Total

Score 5/6 · Full Assessment → Strong Potential

Well-captured in PRO-ACT. Minor timing differences at assessment windows. Edaravone use post-2017 addressed via sensitivity analysis.

Age at Onset

Score 6/6 · Full Assessment → Strong Potential

Consistently captured. All criteria met. Only gap is investigator non-involvement in PRO-ACT data collection.

VC% Predicted

Score 2/6 · Pocock + FDA → Limited Potential

High missingness (28.4%), SVC vs FVC measurement differences, and inconsistent timing drive multiple "Not Aligned" FDA ratings.

Disease Duration

Score 4/6 · No framework assessment → Preliminary

Good baseline score but Pocock, FDA, and Gray not yet completed. Try rating it yourself to see the verdict update.

Riluzole Use

Score 5/6 · No framework assessment → Preliminary

Strong initial score. Use this as a practice variable to complete the Pocock, FDA, and Gray assessments.

Try It Yourself

1 · Explore Verdicts

Go to the Report tab to see the composite verdict bars for all five variables side-by-side.

2 · Rate a Variable

Go to Pocock's Criteria, select "Riluzole Use at Baseline", and rate the seven criteria to see the verdict ring animate.

3 · Export a Report

Go to Report and click Full Report (CSV) to download the synthetic data in the export format.

4 · Use the Real Tool

Click Use Real Tool in the banner above to open index.html with a clean, empty workspace for your own study.

In Development

OMOP Data Scan

🔭

Coming Soon

The OMOP Data Scan will scan OMOP CDM–formatted data using pre-specified concept codes, enabling automated data characterization.

BETA · IN DEVELOPMENT