External comparators (ECs) are increasingly used in drug development, rising 22% between 2015–2019, with growth fueled by FDA’s 2023 draft guidance and expanding real-world data. ECs streamline trial design, reduce control arm size, strengthen HTA submissions, and improve market positioning. IQVIA’s Regulatory Science & Study Innovation team supports sponsors through feasibility assessments, robust EC design, and regulator engagement. With 80+ supporting studies, 25+ ECs executed, and 550+ EU5 HTA submissions, IQVIA helps mitigate risks, optimize product lifecycles, and align with global regulatory expectations to drive efficient, evidence-based development.

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