Real World Evidence
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Fact Sheet
Unlocking Success in Drug Development with External Comparators
IQVIA’s expert guidance and advanced methodologies can enhance the design of external comparators for regulatory decisions
May 27, 2024
The use of external comparators (ECs) in drug development is on the rise, fueled by real-world data (RWD) and advancements in personalized medicine. Notably, the period from 2015 to 2019 saw a 22% increase in RWD-based EC usage. This upward trend is expected to continue, especially following the FDA’s February 2023 draft guidance, which advocates for a nuanced, case-by-case assessment of EC cohort designs.
While EC studies can significantly augment product lifecycles, from streamlining clinical trial design to strengthening real-world evidence (RWE) for payor negotiations and market positioning, the question arises: How can sponsors effectively advocate for their utilization to address the needs of a drug development program?