# Bridging the Generalisation Gap: Synthetic Data Generation for Multi-Site Clinical Model Validation

arXiv: https://arxiv.org/abs/2504.20635 · HTML: https://mlsanity.com/paper/2504.20635/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 3 of its 17 references that are in the map.
- First posted on arXiv 29 Apr 2025.

## Builds on (most cited first, 3 of 3)

- [XGBoost: A Scalable Tree Boosting System](https://mlsanity.com/paper/1603.02754/) (2016)
- [Synthetic Data in AI: Challenges, Applications, and Ethical Implications](https://mlsanity.com/paper/2401.01629/) (2024)
- [Why Do Probabilistic Clinical Models Fail To Transport Between Sites?](https://mlsanity.com/paper/2311.04787/) (2023)

## Abstract (arXiv)

Ensuring the generalisability of clinical machine learning (ML) models across diverse healthcare settings remains a significant challenge due to variability in patient demographics, disease prevalence, and institutional practices. Existing model evaluation approaches often rely on real-world datasets, which are limited in availability, embed confounding biases, and lack the flexibility needed for systematic experimentation. Furthermore, while generative models aim for statistical realism, they often lack transparency and explicit control over factors driving distributional shifts. In this work, we propose a novel structured synthetic data framework designed for the controlled benchmarking of model robustness, fairness, and generalisability. Unlike approaches focused solely on mimicking observed data, our framework provides explicit control over the data generating process, including site-specific prevalence variations, hierarchical subgroup effects, and structured feature interactions. This enables targeted investigation into how models respond to specific distributional shifts and potential biases. Through controlled experiments, we demonstrate the framework's ability to isolate the impact of site variations, support fairness-aware audits, and reveal generalisation failures, particularly highlighting how model complexity interacts with site-specific effects. This work contributes a reproducible, interpretable, and configurable tool designed to advance the reliable deployment of ML in clinical settings.