Presentation (CTI)

OBJECTIVES: To conduct a targeted literature review to identify, analyze, and compare existing guidelines for the use of real-world evidence (RWE).
METHODS: Comprehensive searches were conducted in publication platforms like PubMed and Google Scholar to identify studies comparing existing RWE guidelines. The key search terms used included “guideline*,” “real world evidence,” “RWE,” “real world data,” and “RWD,” etc. No specific inclusion and exclusion criteria were applied, and no restrictions in timeframe, language, or geographical scope were imposed. The searches were not expanded to include academic and non-academic articles and conference abstracts.
RESULTS: The search identified 24 hits, of which only 5 RWE guidelines (REALISE group, NICE, HAS, NMPA, and CADTH) were included in this review. Real-world data (RWD) refers to administrative data from the provision of care that can be used for research purposes. RWE can come from a variety of research designs or analyses, such as observational studies, big simple trials, pragmatic trials, and randomized trials. Identified guidelines such as NICE, HAS, NMPA, and the REALISE group provide recommendations on when and how to use RWE, emphasizing its role in characterizing health conditions, estimating economic burden, and supporting drug regulatory decisions. Regulatory agencies have framed RWE guidelines to advance their use in submissions, increasing their importance. This has increased the importance of improving the process of collecting RWD that can facilitate good quality outputs.
CONCLUSIONS: Leveraging RWE can significantly enhance the efficiency and effectiveness of healthcare research and market access. By utilizing digitized health data, AI technology, and scalable computational power, RWE offers a promising solution to the challenges of drug development. Even so, additional research is required to examine how applying the current RWE standards can enhance patient outcomes in everyday practice.