Proposal of a System for Prototyping and Validation of Drug Efficacy and Safety Evaluation Methods

COVID-19 pandemic showed how fast new drugs can be introduced and the need for reliable drug efficacy and safety evaluation methods. Lack of past data that could be used for evaluation and validation of such methods limits possibility to work on them before real data is available. Using a common electronic health record data type as well as possibility to generate synthetic data could allow early validations and end to end testing of such methods. To address these limitations, a system was proposed system that allows for end-to-end patient population generation, data transformation and method evaluation. The system utilizes existing and well-known patient generation framework Synthea, as well as OMOP CDM data model along with patient level prediction framework. Existing solutions were extended for the purposes of the system including possibility of modelling adverse drug reactions in Synthea and orchestrated for seamless execution. Proposed system allows for prototyping and validating drug efficacy and safety methods using existing state-of-the art tooling as well as providing a holistic approach to method evaluation and testing.