P325: Proposed Areas of International Harmonization of Real-World Evidence Standards Among Medical Product Regulators
Poster Presenter
Molly Shields
Policy Analyst, Assistant
Duke-Margolis Institute For Health Policy (DMI) United States
Objectives
The Duke-Margolis Institute for Health Policy developed a public online “International Harmonization of RWE Standards Dashboard” to offer timely updates for real-world data/evidence (RWD/E) stakeholders, highlighting areas of regulatory alignment and misalignment in international RWD/E guidance.
Method
Ongoing structured analyses of documents (draft and final) sourced from the dashboard (n = 51) indicate areas of alignment and misalignment around RWD/E terminology (relevance, reliability, quality, fit for use, fit for purpose) and assurance procedures.
Results
As of March 2026, we identified 61 RWD/E guidance documents released by regulators globally, with US FDA (n = 14) and Japan PMDA (n = 12) having released the most documents. FDA (n = 15) and EMA (n = 11) were cited most frequently by other regulators, but most guidance did not cite other regulators (n = 33). RWD (n = 29), RWE (n = 23), relevance (n = 11), and reliability (n = 10) were the most defined terms with many guidance documents (n = 19) not defining any identified key terminology.
Preliminary findings show emerging areas of alignment and misalignment among definitions and assurance procedures. Definitional alignment of reliability includes accuracy, completeness, and traceability; alignment of assurance procedures includes data management (missingness and accuracy) and formatting (e.g., standardized codes). Definitional alignment of relevance includes sufficient key variables; alignment of assurance procedures includes developing exclusion and inclusion criteria and evaluating context and objectives. Definitional alignment of quality includes accuracy and validity of data, and alignment of assurance procedures includes timeliness of source data and documentation of data transformation, curation, linkage, and mapping.
There was misalignment on whether relevance pertains to a research question (EMA) or regulatory context (FDA, MFDS). Additional regulator misalignment attributed data accuracy to both reliability and quality and representative datasets to both relevance and reliability. Both fit for use and fit for purpose were defined as reliable and relevant; however, more documents defined fit for purpose (n = 6) than fit for use (n = 2).
Conclusion
Our findings illustrate opportunities for regulators to advance areas of alignment and address potential areas of misalignment around key RWE terminology and assurance procedures. This ongoing work shapes RWE regulatory policy discussions with timely, publicly available policy updates that guide operational RWE goals and standards among regulators, health technology assessment bodies, payers, researchers, and other regulatory stakeholders.
