Real-world evidence (RWE) is increasingly influencing healthcare decision-making, but most industry-sponsored RWE studies are not intended for regulatory submission or reimbursement.[1] Many of these studies are performed rigorously, but the majority of unsubmitted RWE often lacks consistent pre-protocol specification, analytical transparency, and structured oversight, leading to variability in quality and trustworthiness.[1] The problem is not primarily caused by individual errors or intentional deficiencies, but rather by structural deficiencies in the management system.[1] Tools for improving unsubmitted RWE already exist, but their application is uneven.[1] The article proposes a framework based on three pillars: protocol registration, analytical transparency and adequate internal governance, including responsibility for patient data.[1] Extending these safeguards to all RWE studies would increase the underlying quality of the evidence and strengthen confidence in its reliability.[1]