Advancing regulatory science through real-world data and real-world evidence

RWD can now be generated from multiple sources and at a much faster pace than traditional and more standardized clinical research information data collection sources (such as traditional case report forms), thus having the potential to, more accurately and in real time, mimic the health journey of individuals and enrich our data universe in healthcare and research. However, utilization, integration, infrastructure, representativeness, privacy, security, and data sharing remain critical aspects for high quality, equitable, and secure RWD. The amalgamation of manuscripts herein provides a broad picture of sources, utilization, applicability, infrastructure, challenges, and opportunities to obtain meaningful RWD and generate the necessary RWE to ultimately improve the health journey for all. Copyright © The Author(s), 2024. Published by Cambridge University Press on behalf of Marine Biological Association of the United Kingdom.