Property-Driven Synthetic Data Engineering for Data-Scarce Software Systems: Reflections from the Breast Cancer Domain
Authors: Aurora Francesca Zanenga, Andrea Bombarda, Marsha Chechik, Saverio D'Amico, Rita De Sanctis, Alberto Zambelli, Claudio Menghi
Abstract
Modern software systems increasingly depend on data for analysis, prediction, testing, and decision-making. Yet many important domains, including medicine, safety-critical systems, and regulated industries, lack abundant, shareable, or representative data. Synthetic data generation is often proposed as a remedy, but our experience engineering software for intraoperative radiotherapy (IORT) in breast cancer treatment suggests that synthetic data shifts rather than solves the central engineering problem. The key challenge becomes deciding which properties synthetic data must preserve, how these properties should be elicited from stakeholders, how they can be validated under privacy constraints, and how they evolve. We call this problem property-driven synthetic data engineering. Drawing on a collaboration with oncologists and preliminary experiments with a sensitive IORT dataset, we identify challenges in requirements, validation, privacy, and pipeline evolution. We argue that automated software engineering research should develop methods and tools for eliciting, formalizing, checking, and evolving validity properties for synthetic data in data-scarce software systems.
Synthetic data is widely used in healthcare to create datasets that preserve statistical properties of real data without exposing sensitive patient information. Generating and evaluating synthetic data across privacy, utility, and fairness dimensions is crucial for enabling high-quality data availability in downstream prediction tasks and clinical decision making. We present \textbf{Memisis}, a tool that orchestrates and evaluates synthetic data by leveraging existing synthesis libraries, large language models (LLMs), and state-of-the-art evaluation metrics. Our tool creates a unified workflow for data generation, validation, and evaluation. Users can control training size, training epochs, and the number of synthetic rows to sample. Beyond manual configuration, an interactive agent mode allows users to specify data generation goals in natural language, and the tool orchestrates the full pipeline by invoking existing synthesizers while performing the requisite evaluation. For the demo, we use an open-source schizophrenia dataset with protected attributes related to race and gender, evaluate six synthesizers spanning GANs, VAEs, diffusion models, and normalizing flows, and use a local LLM to orchestrate the workflow. The system affords users flexibility and control over the data generation and evaluation process.
In oncology, access to patient-level data is often restricted. Synthetic data provides an alternative for analyzing treatment effectiveness, but existing methods for synthetic data generation fail to preserve the causal relationships between covariates, treatments, and outcomes, thereby leading to biased estimates of treatment effects. Here, we introduce OncoSynth, a generative, causally-aware machine learning framework designed to produce synthetic cohorts that enable accurate estimation of population- and patient-level treatment effects. OncoSynth uses a diffusion-based sequential approach to model how covariates influence treatment assignment and how treatment affects survival. We evaluate OncoSynth using large lung (N = 37,128) and breast cancer (N = 17,046) cohorts. Our results show that OncoSynth generates high-fidelity synthetic patient cohorts that preserve real-world patient, treatment, and outcome distributions. Notably, OncoSynth improves treatment effect estimation over existing approaches, by reducing population-level treatment effect error by up to 66%, and patient-level treatment effect error by up to 58%. Thereby, OncoSynth supports reliable evidence generation for precision oncology in settings where data sharing is restricted.
Octavia-Andreea Ciora, Julian Welzel, Dennis Frauen +6
Access to clinical data is essential for developing reliable healthcare machine learning systems, but direct use of electronic health records is constrained by privacy regulation, institutional review, data-use agreements, and the risk of re-identification. Synthetic data promises a practical alternative: it can preserve useful statistical and clinical structure while reducing exposure of sensitive patient records. Prior studies often evaluate a single generator, one dataset, or a narrow downstream task, making it difficult to know when synthetic data can support model development and when it fails to preserve task-critical signal. We introduce CoMedBench, a reproducible benchmark that evaluates a family of generators under a common clinical-validity framework and one shared training and evaluation engine, spanning static tabular and temporal downstream tasks on established critical-care datasets. In total the benchmark spans 37 dataset-task pairs across two modalities consists of 20 static tabular and 17 temporal ICU time-series-drawn from seven public data sources: three intensive-care databases (MIMIC-III, MIMIC-IV, and eICU) together with the UCI Machine Learning Repository, the CDC BRFSS diabetes cohort (2015), NHANES (1999-2014), and the pycox survival datasets (GBSG and METABRIC). The benchmark evaluates both statistical fidelity and task utility by comparing models trained and tested across real and synthetic data. In these settings, synthetic training data preserves most of the downstream signal: on tabular tasks the reference generator CoMed-CTGAN retains a mean AUROC utility (the synthetic-to-real performance ratio) of 90.6%, rising to 97.3% for the strongest generator, CoMed-TVAE. Temporal ICU tasks are harder and more generator-sensitive: CoMed-CTGAN retains 81.6% (AUROC) and only 64.0% under the imbalance-sensitive AUPRC, whereas CoMed-TVAE still retains ~95% (AUROC).
Akanta Das, Al Amin Farhad, Mrinmoy Sarkar Anto +3