Part A · Synthetic Control from Historical EDC
DT-ONC-NSCLC-501 · Phase 3 · endpoint: PFS at Week 24
Classic RCT control N: 210
Borrowed ESS: 157
Observed + Synthetic Control effective control N: 367
Control Arm Reduction: 44.8%
prototype 05
Digital Twin Synthetic Control
Use historical EDC data to build synthetic control evidence, reduce randomized control arm size, and test ProCOVA-style sample-size reduction.
Part B · ProCOVA-style Sample Size Reduction
Classic RCT n/arm: 324
ProCOVA adjusted sigma: 0.806
ProCOVA n/arm: 211
Sample size reduction: 34.9%
Computation Notes
Historical source: EDC · trials ONC-NSCLC-214, ONC-NSCLC-198, ONC-LU-177 · patients 1280.
Synthetic control ESS = historicalPatients × borrowingRatio × matchQuality × calibrationFactor.
Recommended observed control N = base control N - 0.6 × borrowed ESS (floored for minimum operational control).
ProCOVA-style reduction assumes covariate-adjusted variance: sigma_adj = sigma × sqrt(1 - R^2).
n_classic = 2 * (Zalpha/2 + Zbeta)^2 * sigma^2 / delta^2
n_procova = 2 * (Zalpha/2 + Zbeta)^2 * sigma_adj^2 / delta^2
update log
Prototype Change Log
2026-03-01 · v0.1.0
Synthetic Control + ProCOVA Demo Added
- - Added historical EDC driven synthetic control simulation with control-arm reduction estimate.
- - Added endpoint trajectory view for treated, observed control, and synthetic control.
- - Added ProCOVA-style sample-size reduction calculator with transparent formulas.