RWE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 16

Abstract

In this update, we discuss recent US FDA guidance offering more specific guidelines on appropriate study design and analysis to support causal inference for non-interventional studies and the launch of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) public electronic catalogues. We also highlight an article recommending assessing data quality and suitability prior to protocol finalization and a Journal of the American Medical Association-endorsed framework for using causal language when publishing real-world evidence studies. Finally, we explore the potential of large language models to automate the development of health economic models.

Keywords

• causal inference
• causal language framework
• data quality assessment
• fda guidance
• health technology assessment
• large language models
• non-interventional studies
• public electronic catalogues
• real-world data
• real-world evidence
• study design