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Publication Digest: Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience
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, Buccheri et al. explored the challenges of conducting randomized controlled trials (RCTs) for high-risk medical devices, emphasizing the added complexities of intervention costs, patient randomization, and blinding processes.
Drawing on experience from the CORE-MD project and large-scale pharmaceutical trials during the COVID-19 pandemic, the authors highlighted the potential of large simple RCTs for high-risk medical devices. These trials leverage routine healthcare data to improve efficiency, reduce costs, and accelerate patient recruitment while maintaining robust clinical evidence.
Access the full-text article here.