IQWiG critical of EMA's adaptive pathway

In a statement criticizing EMA's adaptive licensing pathway, Germany's Institute for Quality and Efficiency in Health Care said EMA has failed to propose how to draw useful conclusions from real-world data, a key component of the pathway.

Launched via a pilot program in 2014, the pathway is designed to bring drugs to market through iterative phases of evidence gathering and licensing, with further approval or adjustments based on postmarket trials and real-world data (see BioCentury, July 18, 2014). ...