Hospital-based real-world evidence in health technology assessment: insights from a scoping review of European, Australian and North American guidance and expert interviews

There is a lack of harmonisation in assessing RWE among HTA and regulatory agencies. The available RWE guidance documents provide limited guidance on real-world hospital data. Considering their unique nature and to unlock their potential for HTA, we emphasise the need for more in-depth guidance tailored to the hospital context.