Real World Replication Of Clinical Trial Findings In Alzheimer’s Disease

While randomized controlled clinical trials are the gold standard for demonstrating efficacy, there is a need to facilitate comparison of trial findings with real world populations. This is evident in the 21st Century Cures Act with the FDA and large public-private initiatives, such as IMI GetReal in Europe. In this study we propose the use of common data model transformation and standardized clinical vocabularies to facilitate replication of the study cohort from an Alzheimer’s trial, publicly available in the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (CDISC SDTM) format, in a real-world data Electronic Medical Record data source.3 For data transformation, the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) was used.