Insight Brief
Mapping Feasibility Criteria Across 46 Real-World Evidence Guidelines, Gap Analysis, and IQVIA's Mitigation Strategies
Mar 06, 2025
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Database studies can be an efficient, cost effective, and ethical way to research a condition or therapeutic using data captured in the real-world to generate evidence on safety and effectiveness. Researchers can gain approval to analyze retrospective health data, or to plan for future analyses of prospective data. A feasibility assessment can be completed prior to or in tandem with protocol development to evaluate the key study specific variables, data access logistics, and sample size of patient cohorts to inform a non-biased selection of fit-for-purpose data sources for a protocol design.

This Insight Guide builds upon the build on insights from the Contemporary Practice and Considerations for Real-World Data Source Identification and Feasibility Assessment, developed in 2022 as a part of an International Society for Pharmacoepidemiology (ISPE)-funded initiative. IQVIA aimed to identify and map guidelines released after its development, and ultimately included 32 additional publications.

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