Volume 2: Real World Evidence (RWE): Paths to Enhancing Patient Access to New Medications

The growing availability of real-world data (RWD)—from electronic health records, claims databases, patient support programs, and disease registries—together with major advances in analytical methodologies, including artificial intelligence, has reshaped the generation and application of real-world evidence (RWE). High-quality RWE is increasingly recognized as a critical complement to traditional clinical trial data for informing healthcare decision-making.

Building on the foundation established in Volume 1, which addressed key methodological challenges in RWE generation, Volume 2 of this Special Issue focuses on the pragmatic use of RWE to improve and accelerate patient access to medicines. With recent guideline updates from regulatory authorities, reimbursement agencies, and advertising control boards explicitly endorsing the use of robust RWE, its role in supporting regulatory approval, reimbursement decisions, and communication is rapidly expanding.

This article collection brings together six peer-reviewed articles published in Volume 2, highlighting practical applications of RWE in regulatory and access contexts. Collectively, these contributions provide timely insights for researchers, regulators, and industry stakeholders navigating the evolving RWE landscape.

Keywords: real world evidence, real world data, common technical document, novel medications, patient care, patient data