RWE Studies From Sites and Databases May Not Always Be Enough

When responding to health authorities’ and payers’ real-world evidence (RWE) requirements, sponsors can execute retrospective database studies or prospective studies, such as clinical site chart reviews. Database studies offer quicker insights, but often lack the clinical precision required to address increasingly sophisticated research questions. Site-based studies offer richer data, but they require manual processes that lengthen timelines and drive up cost. Rich patient-level data obtained directly from clinical site EMRs have become increasingly attractive as a source that could rationalize spend and accelerate insights.