The unregulated majority: who ensures quality in non-submission real-world studies?

Real-world evidence (RWE) plays an increasingly important role in healthcare decision-making, yet most industry-sponsored RWE studies are not intended for regulatory or reimbursement submission. While many such studies are conducted rigorously, this non-submission evidence base often operates without consistent protocol pre-specification, analytical transparency, or structured oversight, creating variability in quality and credibility. This Policy Brief examines this governance blind spot and argues that the challenge is structural rather than individual or intentional. Drawing on regulatory pilots and harmonisation initiatives, it shows that tools to strengthen non-submission RWE already exist but are unevenly applied. A framework is proposed based on three pillars: protocol registration, analytical transparency, and proportionate internal governance, including accountability for patient-contributed data. Extending these safeguards beyond submission-grade studies would raise baseline RWE quality and strengthen trust in RWE.