In recent years, numerous medicines regulatory agencies have shown an increasing willingness to consider real-world evidence (RWE) to support claims of efficacy, effectiveness, and safety. RWE derived from the review and analysis of real-world data (RWD). This shift is transforming the regulatory environment, emphasising the importance of RWE in decision-making processes.
A new consensus report by the Council for International Organizations of Medical Sciences (CIOMS) has been released in May 2024 to outline the potential use of RWE in regulatory and healthcare decisions. The report covers several key topics:
– How RWE can influence regulatory and healthcare decisions.
– Types of real-world data and their sources.
– Scientific principles in generating reliable RWE.
– Ethical considerations and challenges in using RWD.
The report is intended for a broad audience, including regulators, healthcare payers, industries, researchers, bioethicists, patients, and healthcare professionals. It seeks to inform discussions on the use of RWD and RWE for various decision-making purposes, including product authorisation, reimbursement, and clinical use.
This comprehensive guide is expected to play a pivotal role in shaping the future of regulatory and healthcare decision-making by leveraging real-world data to ensure safer and more effective medicinal products.
The integral version of the document can be accessed here.