Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance

Decision-makers have become increasingly interested in incorporating real-world evidence (RWE) into their decision-making process. Due to concerns regarding the reliability and quality of RWE, stakeholders have issued numerous recommendation documents to assist in setting RWE standards. The fragmented nature of these documents poses a challenge to researchers and decision-makers looking for guidance on what is 'high-quality' RWE and how it can be used in decision-making. We offer researchers and decision-makers a structure to organize the landscape of RWE recommendations and identify consensus and gaps in the current recommendations. To provide researchers with a much needed pathway for generating RWE, we discuss how decision-makers can move from fragmented recommendations to comprehensive guidance.

Automated summary

There is a growing interest in incorporating real-world evidence (RWE) into decision-making processes among decision-makers. Stakeholders have issued multiple recommendation documents to set RWE standards, but the fragmented nature of these documents poses challenges for researchers and decision-makers seeking guidance. This paper provides a structure to organize RWE recommendations, identify consensus and gaps, and offers pathways for researchers to generate RWE, discussing how decision-makers can transition from fragmented recommendations to comprehensive guidance.