Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline

This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes.

A non-interventional study is a clinical study that does not fulfil any of the conditions defining a clinical trial in Article 2.2(2) of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

Real-world data describe patient characteristics (including treatment utilisation and outcomes) in routine clinical practice. 

Real-world evidence is derived from the analysis of real-world data.

Keywords: Non-interventional study, real-world data, real-world evidence, feasibility assessment, bias, confounding, data quality

Public consultation

Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence

Consultation dates: 03/05/2024 to 31/08/2024Draft: consultation openReference Number: EMA/CHMP/150527/2024