A Framework for Generating Realistic Synthetic Tabular Data in a Randomized Controlled Trial Setting

Generation of realistic synthetic data has garnered considerable attention in recent years, particularly in the health research domain due to its utility in, for instance, sharing data while protecting patient privacy or determining optimal clinical trial design. While much work has been concentrated on synthetic image generation, generation of realistic and complex synthetic tabular data of the type most commonly encountered in classic epidemiological or clinical studies is still lacking, especially with regard to generating data for randomized controlled trials (RCTs). There is no consensus regarding the best way to generate synthetic tabular RCT data such that the underlying multivariate data distribution is preserved. Motivated by an RCT in the treatment of Human Immunodeficiency Virus, we empirically compared the ability of several strategies and three generation techniques (two machine learning, the other a more classical statistical method) to faithfully reproduce realistic data. Our results suggest that using a sequential generation approach with an R-vine copula model to generate baseline variables, followed by a simple random treatment allocation to mimic the RCT setting, and subsequent regression models for variables post-treatment allocation (such as the trial outcome) is the most effective way to generate synthetic tabular RCT data that capture important and realistic features of the real data.