Key enablers and barriers to implementing adaptive pathways in the European setting.

ABSTRACT

In 2016, the European Medicines Agency published the conclusions of its pilot on adaptive pathways, with products in early stages of development still building up to their marketing authorisation. Adaptive pathways rests on three principles iterative development; gathering evidence through real-life use to supplement clinical trial data; and early engagement of patients, payers and health technology assessment bodies in discussions on a medicine's development. While the pilot has now finished, the practical system-wide implications of employing the adaptive pathways approach are not known and further consideration of these three principles is required. In this paper we used the three principles that underpin adaptive pathways to discuss main scientific and European policy developments likely to determine progress on further implementing adaptive pathways in the European setting.