Key enablers and barriers to implementing adaptive pathways in the European setting.
Juan Carlos Rejon-ParrillaPall JonssonJacoline C BouvyPublished in: British journal of clinical pharmacology (2019)
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.
Keyphrases
- clinical trial
- healthcare
- public health
- end stage renal disease
- chronic kidney disease
- mental health
- study protocol
- randomized controlled trial
- social media
- quality improvement
- magnetic resonance imaging
- peritoneal dialysis
- electronic health record
- big data
- deep learning
- climate change
- phase ii
- phase iii
- image quality