Key enablers and barriers to implementing adaptive pathways in the European setting
| Autor: | Pall Jonsson, Juan Carlos Rejon-Parrilla, Jacoline C. Bouvy |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Pharmacology
Iterative and incremental development Technology Assessment Biomedical Process management Computer science Biomedical Technology Health services research Reviews Health technology Erikson's stages of psychosocial development Evidence-based medicine 030226 pharmacology & pharmacy Europe 03 medical and health sciences 0302 clinical medicine Drug Development Agency (sociology) Key (cryptography) Humans Pharmacology (medical) 030212 general & internal medicine Policy Making Drug Approval Health policy |
| Zdroj: | Br J Clin Pharmacol |
| ISSN: | 1365-2125 0306-5251 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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