Data & Quality
Real-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
RWD sources include EHRs, administrative claims, disease registries, patient-generated wearable data, and pharmacy dispensing records. RWE is increasingly accepted by FDA and EMA to support label expansions, post-marketing requirements, and; under the 21st Century Cures Act; certain efficacy claims.
In trial design, RWD enables prevalence estimation, eligibility-criterion impact modeling, comparator arm construction (synthetic controls), and feasibility benchmarking. Quality, provenance, and fit-for-purpose assessment are essential; not every RWD source is suitable for every regulatory question.
Related terms
Feasibility Assessment
A feasibility assessment is a structured evaluation of whether a planned clinical trial can recruit enough eligible patients, at qualified sites, within the required timeline and budget, given a specific protocol design.
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
EHR Integration (for Clinical Trials)
EHR integration in clinical research is the secure, standards-based connection between an electronic health record system and a clinical-trial application that enables eligibility screening, data abstraction, and source-data verification without manual transcription.
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