2015: Real-world data for benefit assessments: How can registries and routine data contribute?

Benefit assessments of medical interventions are conducted to answer the question: What is the benefit and possible harm of the intervention for patients? It has been repeatedly demanded to use not only the results from “artificial” randomized controlled trials to answer this question, but also data from the actual health care setting (real world).

This raises some obvious questions: What are the characteristics of these data and what specific contribution could they make to benefit assessments? What requirements would they have to meet to provide a basis for valid conclusions? Is it acceptable to accelerate drug approval on the basis of a weaker evidence base, referring to later real-world data? These were the main questions discussed at the IQWiG Autumn Symposium held on 27 and 28 November 2015.