Posted by Michael Wonder on 09 Aug 2016
Adaptive pathways: EMA still leaves open questions unanswered
9 August 2016 - Current EMA report on the pilot project again documents perplexity regarding the use of “real world data”.
At the beginning of August, the EMA published a report on a pilot project of a new accelerated path for drug approval (adaptive pathways). In this approval procedure, for a highly restricted population drugs are to 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.
The German Institute for Quality and Efficiency in Health Care (IQWiG) again sees its concerns about adaptive pathways confirmed by the EMA report. This is because evidently neither industry nor EMA has a concept as to how real world data can be used after drug approval to allow drawing reliable conclusions on benefit and harm.
