ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
This article is part of the Research TopicIncreasing Importance of Patients-generated Real World Data for Healthcare Policy Decisions about Medicinal Products: Volume IIIView all 13 articles
Navigating Barriers to Real-World Evidence Utilization for Drug Regulations and Market Access in Saudi Arabia
Provisionally accepted
Hatouf Husni Sukkarieh1*
Nourah al Fayez2
Hussain Abdulrahman Al-Omar3Nura O. Azmi1Bushra Syed1Raed A. Albar1Nawaf Al Bali1,4- 1Alfaisal University College of Medicine, Riyadh, Saudi Arabia
- 2Alfaisal University College of Business, Riyadh, Saudi Arabia
- 3King Saud University, Riyadh, Saudi Arabia
- 4Council of Health Insurance, Riyadh, Saudi Arabia
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Background: Data-driven, evidence-based decision-making is crucial for guiding complex and often conflicting decision-making in health systems. This study explored the barriers and challenges faced by stakeholders in generating and using real-world evidence (RWE) in Saudi Arabia, focusing on pharmaceutical regulatory, reimbursements, and research landscapes. Methods: Semi-structured interviews were conducted with Saudi stakeholders working in regulatory organizations, research institutions, and the pharmaceutical industry using a topic guide. Purposeful sampling was used to select study participants. The interview topic guide included three main open-ended questions focused on the participants' current experiences, existing barriers, and potential interventions for overcoming challenges. Thematic analysis was used to identify barrier-and challenge-related themes and subthemes. Findings: 11 stakeholders working in regulatory organizations, research institutions, and the pharmaceutical industry across Saudi Arabia were interviewed. Based on the interviews, we identified four major themes pertaining to the barriers and challenges related to advancing RWE use in Saudi Arabia: data management, local capabilities, resources, and governance. Each theme contained key subthemes. Conclusion: This study reveals critical barriers to RWE generation and utilization in Saudi Arabia. Having clear governance, policies, and guidelines for the collection, standardization, sharing, and utilization of real-world data is crucial for overcoming these barriers and challenges. A multifaceted policy approach characterized by stakeholder engagement, collaboration, and coordinated implementation efforts could help build a robust, unified RWE system that aligns with the Saudi Vision 2030 objectives for a sustainable, data-driven healthcare ecosystem.
Keywords: Real-world evidence, policy, Regulatory, reimbursement, barriers, Saudi Arabia
Received: 24 Sep 2025; Accepted: 14 Nov 2025.
Copyright: © 2025 Sukkarieh, al Fayez, Al-Omar, Azmi, Syed, Albar and Al Bali. 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: Hatouf Husni Sukkarieh, hsukkarieh@alfaisal.edu
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.