Germany's IQWiG raises concerns over use of 'real world data' in adaptive pathways procedure

A European Medicines Agency (EMA) report on its adaptive pathways pilot fails to address concerns about how real world data can be used to draw reliable conclusions after drug approval, says Germany's Institute for Quality and Efficiency in Healthcare (IQWiG).

The EMA’s final report on the pilot project, which started in 2014, was published at the beginning of August. Under the procedure, for a highly restricted population, drugs will be launched on the market faster based on less evidence. Further data on effectiveness, safety, and benefit for broader use are only to be generated after drug approval within everyday health care – as so-called real world data.

But the concept has drawn international criticizm, says IQWiG. Scientists not only question the assumptions underpinning the idea, but also point to difficulties with its implementation.