Presentation (CTI)

OBJECTIVES: Operationalizing RWD feasibility evaluation methods and the reporting structure for the subdimensions of relevance (data availability, adequacy of sample size, representativeness, timeliness, and coverage) and reliability (provenance, completeness, conformance, plausibility, and validity) prior to protocol finalization and data access, presents challenges. The first objective of this research was to compare these terms across recently published RWE guidance. The second objective was to develop aligned descriptions and create a global glossary. The third objective was to design evaluation methods and a reporting structure for each subdimension in the global glossary.
METHODS: Relevance and reliability evaluation methods and subdimension definitions were compared in 13 RWE guidance documents published between 2021 and 2024 by the International Council of Harmonization, European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, and regulators across Asian Pacific, Europe, North America, South America, and the United Kingdom. Next, a global glossary and feasibility evaluation methods for each subdimension were developed. Finally, the glossary and assessment strategies were incorporated into feasibility reporting templates and piloted.
RESULTS: Of the 13 guidelines reviewed, most were missing definitions for each of the 10 subdimensions (with the exception of completeness which was defined in just over half): coverage and representativeness (84.6% [11/13]), adequacy of sample size, conformance, and plausibility (76.9% [10/13]), timeliness (69.2% [9/13]), availability, provenance, and validity (53.8% [7/13]), and completeness (46.2% [6/13]). Feasibility evaluation methods for relevance were found in 15.4% (2/13) of guidance documents, however, 0 guidelines included feasibility evaluation methods for reliability. Creating a global glossary and corresponding feasibility evaluation methods bridged a current gap found across published RWE guidelines.
CONCLUSIONS: The global glossary and feasibility evaluation methods developed from this research facilitated consistent assessment of relevance and reliability and their subdimensions. OASIS provided tools to improve RWD source selection which contributed to high-quality RWE that met regulatory standards.