rwevalidate
Validates instantiated patient cohorts on an Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) database for real-world-evidence (RWE) studies. From a single function call it produces a structured validation report in Hypertext Markup Language (HTML) and JavaScript Object Notation (JSON) covering concept coverage, cohort attrition, temporal data density, and covariate feasibility against a comparator. The checks are aligned with the United States Food and Drug Administration (FDA) guidance on real-world data and evidence, FDA (2023) <https://www.fda.gov/media/171667/download>, the Harmonized Protocol Template to Enhance Reproducibility (HARPER), Wang and others (2022) <doi:10.1002/pds.5507>, and the Reporting of Studies Conducted Using Observational Routinely-Collected Data for Pharmacoepidemiology (RECORD-PE) statement, Langan and others (2018) <doi:10.1136/bmj.k3532>. A self-contained example database is bundled so the checks can be run without a live database connection.
- HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force
- The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE)
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