We are thrilled to announce the publication of our Pivotal Evidence paper resulting from the collaborative efforts of the GetReal Institute and Leiden University Medical Center (Leiden UMC).

The Pivotal Evidence Project, initiated and funded through the GetReal Institute, marks a significant milestone in advancing real-world evidence (RWE) considerations in regulatory decision-making. The project, initiated and discussed with members, was brought forward by the Regulatory Science CBG-MEB (Medicines Evaluation Board — thanks to Marjon Pasmooij and Katrien Oude Rengerink) with the GetReal Institute working closely with members to refine its scope and objectives, and Leiden University Medical Center (Leiden UMC) on delivery.

The paper presents a scoping review aimed at identifying factors influencing the necessity and desirability of RWE in regulatory decision-making. Conducted through extensive literature review and analysis, the study identified two major themes and six subthemes, collectively encompassing 43 factors shaping the need for RWE in regulatory decisions.

Interested to Learn More? The full paper provides a comprehensive overview of the themes, subthemes, and factors identified in the scoping review. Supplementary Material S2 contains a detailed list of all factors, complete with descriptions, illustrative quotes, and references.

Real-World Evidence to Inform Regulatory Decision Making: A Scoping Review

This publication represents a significant contribution to advancing our understanding of RWE’s role in regulatory decision-making. We extend our gratitude to all collaborators and stakeholders involved in this initiative.