Session (CTI)

ISSUE Health Technology Assessment (HTA) bodies, regulators, and healthcare decision-makers increasingly require high-quality longitudinal patient-reported outcome (PRO) evidence to evaluate real-world treatment effectiveness and safety, evidence that trial environments alone cannot provide. The infrastructure to support prospective PRO collection now exists: validated instruments such as the EQ-5D-5L, digital collection platforms, and expanding evidence networks such as DARWIN EU® have meaningfully expanded opportunities to generate, characterize, and reuse PRO data in real-world settings. Yet despite this maturity, PRO evidence rarely reaches decision-makers in credible, reusable form. Collection remains fragmented and episodic, fit for individual studies but not designed for repeated use across research questions and decision contexts. The gap is no longer primarily technical. It is structural. OVERVIEW The panel brings together complementary perspectives across the PRO evidence lifecycle: European RWE infrastructure with Prof. Verhamme, patient-centered outcomes implementation with Dr. Rylands, operational evidence generation with Dr. Lawes, and HTA decision science with Prof. Siebert. The session moves from infrastructure realities through to HTA utility, building toward a shared examination of why meaningful generation and reuse of longitudinal PRO evidence continues to lag behind both infrastructure capacity and decision-maker demand. Panelists will explore unresolved tensions around continuity, sustainability, and what "reusable" longitudinal real-world PRO evidence – evidence designed from the outset for repeated use across studies settings, and stakeholders – actually requires in practice. Audience polling will be used at key moments to surface where participants see the sharpest barriers, grounding the moderated discussion in real-world priorities rather than theoretical ones.