Abstract

Regulatory bodies, including the FDA and EMA, endorse real-world evidence (RWE) as a part of patient-focused drug development, encouraging manufacturers to conduct RWE research. Despite the potential for RWE to strengthen randomized clinical trial (RCT) data, there is notable divergence in how HTA and payer organizations incorporate RWE into their decision-making. This research aimed to understand payer perception and evolution of patient-centric approaches in clinical trials and RWE in health technology assessment (HTA) submissions and payer decision-making.

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