Building on ‘Contemporary Practice and Considerations for Real-World Data (RWD) Source Identification and Feasibility Assessment’: Mapping Feasibility Criteria Across 46 Real-World Evidence (RWE) Guidelines
Author(s)
Summer Drummond, DNP MSN1, Julien Heidt, MS1, Deborah Layton, PhD2, Dony Patel, PhD3.
1IQVIA, Durham, NC, USA, 2Lane Clark & Peacock, London, United Kingdom, 3IQVIA, London, United Kingdom.
1IQVIA, Durham, NC, USA, 2Lane Clark & Peacock, London, United Kingdom, 3IQVIA, London, United Kingdom.
Presentation Documents
OBJECTIVES: Regulators and payers are placing increased importance on transparent reporting of feasibility results and data source selection for RWE studies. A recent publication, Contemporary Practice and Considerations for RWD Source Identification and Feasibility Assessment, reviewed 14 published guidance documents and the availability of feasibility assessment criteria as part of an International Society of Pharmacoepidemiology (ISPE) funded initiative. Building on the insights from this publication, we aimed to identify and evaluate new guidelines released after 2022 and incorporate additional geographies.
METHODS: A review of RWD guidelines was conducted and each document was mapped against 14 criteria that were further developed from the aforementioned publication to ensure reproducibility. All mapping was conducted by two independent reviewers with adjudication by a third if discrepancies were identified.
RESULTS: 46 RWD guidelines published between June 2017 to July 2024 were identified from stakeholder organizations such as the International Council for Harmonization (ICH), and regulators in Australia, Brazil, Canada, China, Europe, Japan, UK, and US. Of the 46 guidelines mapped, 97.8% (n=45) were missing >1, 58.7% (n=27) were missing >4, and 30.4% (n=14) were missing >7 of the criteria. The percentage of at least 1 mention for each of the 14 feasibility criteria across 46 guidelines was: study elements (97.8%), reliability (87.0%), relevance (84.8%), validity (80.4%), sample size and bias/limitations (78.3%), provenance (73.9%), coverage, linkage, and governance (58.7%), data dictionary/definitions (54.3%), local ethical requirements (52.2%), data lag/timelines (41.3%), and cost (17.4%).
CONCLUSIONS: This review builds on previous findings and demonstrates that, despite additional guidelines becoming available, there remains a need for a globally harmonized set of feasibility criteria with aligned definitions. Furthermore, findings suggest that further efforts are warranted to address methodological considerations, multi-country and multi-data source evaluations, standardized templates to disseminate results to regulators, and data holder quality management recommendations.
METHODS: A review of RWD guidelines was conducted and each document was mapped against 14 criteria that were further developed from the aforementioned publication to ensure reproducibility. All mapping was conducted by two independent reviewers with adjudication by a third if discrepancies were identified.
RESULTS: 46 RWD guidelines published between June 2017 to July 2024 were identified from stakeholder organizations such as the International Council for Harmonization (ICH), and regulators in Australia, Brazil, Canada, China, Europe, Japan, UK, and US. Of the 46 guidelines mapped, 97.8% (n=45) were missing >1, 58.7% (n=27) were missing >4, and 30.4% (n=14) were missing >7 of the criteria. The percentage of at least 1 mention for each of the 14 feasibility criteria across 46 guidelines was: study elements (97.8%), reliability (87.0%), relevance (84.8%), validity (80.4%), sample size and bias/limitations (78.3%), provenance (73.9%), coverage, linkage, and governance (58.7%), data dictionary/definitions (54.3%), local ethical requirements (52.2%), data lag/timelines (41.3%), and cost (17.4%).
CONCLUSIONS: This review builds on previous findings and demonstrates that, despite additional guidelines becoming available, there remains a need for a globally harmonized set of feasibility criteria with aligned definitions. Furthermore, findings suggest that further efforts are warranted to address methodological considerations, multi-country and multi-data source evaluations, standardized templates to disseminate results to regulators, and data holder quality management recommendations.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD133
Topic
Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas