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Publication Digest: Analytical Methods for Comparing Uncontrolled Trials With External Controls From Real-World Data: A Systematic Literature Review and Comparison With European Regulatory and Health Technology Assessment Practice
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest.
In a recent publication, Hogervorst et al. conducted a systematic literature review to map analytical methods used for comparing uncontrolled trials with external controls derived from real-world data. The authors benchmarked these approaches against European regulatory and HTA practices. The review, encompassing European agency guidelines and assessment reports, revealed a lack of alignment between state-of-the-art methodological recommendations and their practical application in regulatory and HTA decision-making. The authors propose twelve actionable recommendations to bridge these methodological gaps and enhance transparency in the use of real-world data.
Access the full-text article here.