Session (CTI)

Purpose: This workshop explores pragmatic strategies for generating decision-grade real-world evidence to demonstrate clinical impact of medical devices and diagnostics when randomized controlled trials are impractical. Description: Medical devices and diagnostics typically reach market with less clinical evidence than pharmaceuticals, as regulatory pathways emphasize analytical performance rather than patient-relevant outcomes. This creates critical evidence gaps for HEOR and market access teams at launch. The cost, timelines, and feasibility constraints make pharmaceutical-style RCTs unrealistic for most device and diagnostic manufacturers, creating uncertainty for payers and delaying reimbursement despite promising clinical potential. A central question is: what level and type of real-world evidence constitutes 'decision-grade' evidence for HTA and payer evaluations when RCTs are impractical? This workshop explores scalable approaches using real-world data, hospital collaborations, national registries, and regulatory datasets to demonstrate clinical impact. Supporting ISPOR 2030 priorities on RWE readiness and modernizing HTA processes, the session presents three complementary perspectives: Diagnostics HEOR perspective discusses leveraging regulatory, real-world, and post-market datasets to demonstrate clinical utility, and how structured collaborations with research partners accelerate evidence development. Medical device HEOR perspective outlines best practices for designing clinically credible yet resource-efficient clinical impact studies supporting payer decision-making. National registries perspective demonstrates how Scandinavian-style registry infrastructures enable low-cost, high-impact studies on utilization patterns, outcomes, device performance, and comparative effectiveness. Panelists will present practical frameworks for early-lifecycle evidence generation, methodological considerations in non-randomized studies, and real-world examples of successful clinical impact assessments without RCTs.