(C-162) A Fitness-for-use Assessment of Real-World Data Sources and Data Linkage to inform a Post-Authorization Safety Study - A Formalized Feasibility Study

Background: Identifying “fit-for-purpose” real-world data (RWD) is crucial in pharmacovigilance to ensure validity of the drug´s safety study results. Thereby, the generation of real-world evidence (RWE) addressing selected safety outcomes in certain populations exposed to IL-6 inhibitors, requires linkage of individual RWD sources with relevant, complete and good quality data to correctly identify the preselected patient populations, exposure, outcomes, and covariates.

Objectives: To identify data sources with linkage potential which, together, provide “fit-for-purpose” RWD. This feasibility study will inform the study design for an ensuing Post-Authorisation Safety Study (PASS).

Methods: We applied the Structured Process to Identify Fit-for-Purpose Data (SPIFD) framework to data sources in the Health Verity Marketplace, to assess the relevance, availability and completeness of key data elements for an ensuing PASS, including
● Demographics, diagnoses, comorbidities, Il-6 inhibitor exposure: to correctly identify target populations
● Other diagnoses, procedures, treatments, laboratory values: to enable cohort matching and to correctly identify safety outcomes: infections; gastrointestinal perforation; bleeding; malignant neoplasms; liver injury
Individual patients were linked across multiple data types and data sources; key data elements were harmonized ensuring integration of demographic, diagnostic, comorbidity, and treatment information.

Results: Out of 33 candidate data sources with linkage potential, 26 were excluded (belonging to Ambulatory and Hospital EHR, Chargemaster or Mortality data sources) as they were deemed not fit-for-purpose, primarily due to irrelevance to the study objectives and too many gaps in the data.
The remaining 7 linkable data sources were deemed fit-for-purpose. These included:
● Closed medical and pharmacy claims (n=4): Provided comprehensive longitudinal data, capturing demographics, diagnoses, comorbidities, procedures, treatments, and safety outcomes for a closed population of patients. Did not provide laboratory data.
● Laboratory data sources(n=3): Supported diagnoses reliant on laboratory tests, such as neutropenia, thrombocytopenia, and elevated liver enzymes in patients overlapping with claims

Conclusions: Data source linkage increased the completeness and accuracy of the dataset, providing more precise cohort matching and reliable identification of safety outcomes, thus enhancing the potential for the ensuing PASS to generate real-world evidence (RWE) to support regulatory decision-making. Formalized Data linkage feasibility studies may improve the credibility and reliability of postmarketing drug safety research.