POLICY BRIEF article
Front. Med.
Sec. Regulatory Science
The Unregulated Majority: Who Ensures Quality in Non-Submission Real-World Studies?
HELIOS ACADEMY LIMITED, London, United Kingdom
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Abstract
Real-world evidence (RWE) plays an increasingly important role in healthcare decision-making, yet most industry-sponsored RWE is not intended for regulatory or reimbursement submission. Although many studies are rigorously conducted, this non-submission evidence base often lacks consistent protocol pre-specification, analytical transparency, and structured oversight, leading to variability in quality and credibility. This Policy Brief identifies a structural governance gap rather than individual shortcomings. Drawing on regulatory pilots and harmonisation initiatives, it shows that tools to strengthen RWE already exist but are unevenly applied. It proposes a three-pillar framework: protocol registration, analytical transparency, and proportionate internal governance, including accountability for patient-contributed data. Extending these safeguards beyond submission-grade studies would elevate baseline RWE quality and reinforce trust in real-world research.
Summary
Keywords
Analytical transparency, governance, Non-submission Studies, observational research, pharmaceutical industry, ProtocolRegistration, Real-world evidence (RWE), ScientificIntegrity
Received
05 January 2026
Accepted
13 February 2026
Copyright
© 2026 Sagkriotis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Alexandros Sagkriotis
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.