Case study

16 Dec 2020

Rescue of a Global Phase III Orphan Drug Study for Hypoparathyroidism


Overview

Investigator identification and patient recruitment are critical in an orphan drug clinical trial and this is magnified when a trial is failing. This complex Phase III trial for hypoparathyroidism was being conducted across Central/Eastern Europe and North America. The incumbent international CRO was unable to meet the enrollment timelines and costs were escalating. Of the target patient enrollment, approximately 95% had yet to be identified when TFS assumed full-service responsibility for this study.


    Challenges

    • Enrollment timelines at risk — over reliance on KOL enrollment
    • Only 60% of sites identified — only 5% of patients enrolled
    • Sites underperforming & lagging site initiation
    • Vendor contracts held by incumbent CRO
    • Incumbent CRO retained on-going data management & biostatistics responsibilities

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