Posted by Michael Wonder on 04 Aug 2016
Adaptive pathways: key learnings and next steps
3 August 2016 - EMA publishes report on pilot project and will organise workshop in December to further explore concept
The EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs.
The pilot project, which has now ended, showed that adaptive pathways can bring multiple stakeholders together – regulators, health technology assessment bodies, healthcare professionals and patients – to agree on a prospective plan to generate data on a medicine across its lifespan in areas of unmet medical need. Adaptive pathways can support medicine development in therapeutic areas where evidence generation is challenging, such as infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.
