CIOMS Unveils Groundbreaking Consensus Report on Real-World Evidence and Its Impact on Regulatory Decision Making

CIOMS report Real-World Data (RWD) Real-World Evidence

The Council for International Organizations of Medical Sciences (CIOMS) has taken a significant step forward in shaping the future of healthcare and regulatory frameworks with the release of its consensus report by Working Group XIII. This landmark publication delves into the use of real-world data (RWD) and real-world evidence (RWE) in regulatory and healthcare decision making.

As the healthcare landscape evolves, so does the potential of RWE to support critical decisions concerning the authorisation, reimbursement, and clinical use of medicinal products. CIOMs' latest report offers comprehensive insights into the utilization of RWE, exploring not only its scientific aspects but also addressing the ethical and governance issues surrounding RWD.

Why This Report Matters: The willingness of many medicines regulatory agencies to consider RWE in evaluating the efficacy, effectiveness, and safety of medical interventions marks a pivotal change. This report, developed with input from a wide array of stakeholders including regulators, healthcare payers, industry professionals, researchers, bioethicists, and patients, provides crucial guidance on navigating this evolving regulatory environment.

For Whom: This publication is designed for anyone involved in healthcare and medicinal product regulation—be it at a decision-making level or in clinical practice. Whether you're a healthcare professional, a regulator, or part of the healthcare industry, this report is an invaluable resource that will help you understand and implement RWE in your work.

Availability: The report is now available for download at https://doi.org/10.56759/kfxh6213, and hard copies will be available from July 2024.

We encourage all stakeholders to explore this report and consider how RWE can be integrated into their professional practices and decision-making processes. Please feel free to share this information within your networks to broaden the impact of this essential work.

For more information and to download the report, please visit CIOMS’ publication page.