Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies.

ABSTRACT: The potential of real-world data (RWD), particularly from patient registries, has been increasingly recognized over the last decade by academia, regulators, and health technology assessment (HTA) bodies for its role in assessing a product's effectiveness and supporting regulatory submissions. The selection of an appropriate RWD source is of primary concern, since the success of regulatory processes depends on the quality and relevance of the data. In more recent years, EMA and FDA have released extensive guidance on the use of RWD to produce evidence. Simultaneously, public and private research institutions have proposed structured frameworks developed to guide stakeholders in evaluating and selecting "fit-for-purpose" RWD sources. This scoping review provides an overview of these structur

SUBMITTER: Zebachi S 

PROVIDER: S-EPMC12439006 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature