AUTHOR=Costa Valton , Custodio Marcelo Graziano , Gefen Eran , Fregni Felipe 

TITLE=The relevance of the real-world evidence in research, clinical, and regulatory decision making

JOURNAL=Frontiers in Public Health

VOLUME=Volume 13 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1512429

DOI=10.3389/fpubh.2025.1512429

ISSN=2296-2565

ABSTRACT=The scientific method has been established as the optimal approach for systematically gathering and interpreting data on various human phenomena, mainly through the adoption of strict experimental methods, such as controlled randomized trials, which is relevant for clinical decision-making and research, but also weights the regulatory processes for approval of drugs and other medical products. However, a key factor in strict methods is the generalizability of findings that may be limited to specific settings and patient characteristics. This limitation can be addressed by non-experimental methods aimed at investigating populations in naturalistic routine clinical settings, which may offer a more representative reflection of the usage, effectiveness, and safety of healthcare interventions. These approaches can generate the so-called real-world data and the resulting real-world evidence. In this narrative review, we present these concepts, explore the potential applications and advantages of real-world evidence for clinical, research, and regulatory decision-making, and discuss the challenges of employing it, the solutions to improve its generation, and lastly the current level of evidence required for the integration of real-world evidence into regulatory decision-making. We concluded that the advantages of using it, when utilized in a balanced manner, overcome the challenges and, therefore, can offer a time- and cost-saving solution for researchers, the healthcare industry, regulatory agencies, policymakers, and payers towards the patient benefit. The knowledge generated by this approach provides valuable additional insights into medical interventions in real patients under realistic daily scenarios.