EMA adaptive pathways workshop report accessible now
Posted on 01/03/2017
The European Medicines Agency (EMA) has published a new Adaptive Pathways workshop report. This workshop was held in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach, in light of the practical experience gained during the pilot project EMA ran between March 2014 and August 2016, and to plan the next steps in the exploration of this concept. You can access the report, as well as the presentations and videos from the workshop, on the EMA website.
The adaptive pathways concept is an approach to medicines approval that aims to improve patients’ access to medicines in cases of high unmet medical need. To achieve this goal, several approaches are envisaged: identifying small populations with severe disease where a medicine’s benefit-risk balance could be favourable; making more use of real world data where appropriate to support clinical trial data; and involving health technology assessment (HTA) bodies early in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare systems.