Clinical Trial Data Challenges: Solutions via FHIR and Semantic Layers

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The core challenge in clinical trials is not merely data collection, but making the data usable for specific clinical questions. Determining patient eligibility requires integrating fragmented information (diagnoses, medication history, lab results) from multiple sources—such as EHRs, claims, and registries—and cross-referencing them using complex temporal and logical criteria. To address this, FHIR provides a structured way to exchange clinical data, and OMOP CDM standardizes observational healthcare data. However, these standards alone are insufficient; the construction of a 'semantic layer' that uniformly defines clinical concepts (eligible patients, abnormal results) is crucial. This semantic layer enables research teams to make decisions across the entire trial lifecycle—from planning to monitoring and evidence generation—based on highly reliable data. This moves beyond simple dashboards to create a system that delivers real-time, actionable insights.