The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach
The development of novel regulatory tools such as adaptive clinical trial design and utilization of real-world evidence are topics of high interest. Recently, the European Medicines Agency (EMA) introduced the Adaptive Pathways (AP) that represents an innovative tool in healthcare systems allowing t...
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doaj-1f9c826fa2e24dcdba0c7f928f9383542020-11-24T20:59:02ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2019-06-01610.3389/fmed.2019.00148456792The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway ApproachGiuseppe NicoteraGianluca SferrazzaAnnalucia SerafinoPasquale PierimarchiThe development of novel regulatory tools such as adaptive clinical trial design and utilization of real-world evidence are topics of high interest. Recently, the European Medicines Agency (EMA) introduced the Adaptive Pathways (AP) that represents an innovative tool in healthcare systems allowing the early dialogue with multiple stakeholders on promising and innovative medicinal products in areas with an high unmet medical need. The innovative aspect in the AP is the early involvement of several stakeholders such as pharmaceutical industry, the Academia, Health Technology Assessment (HTA) bodies, and patient representatives bringing their real experience with the disease and their expectations about the treatment. AP is not a new licensing tool but an opportunity for a very early discussions, before starting the phase II studies, among all stakeholders, including regulators, companies, HTA bodies, and patient representatives on a new potential medicine in areas of high unmet medical need. The aim of this paper is to describe the evolution of the AP approach from the beginning of the pilot project to date, highlighting major advances, and achievement at European level.https://www.frontiersin.org/article/10.3389/fmed.2019.00148/fullregulatory toolsEuropean medicines agencyadaptive pathwaysHTA bodiesiterative development |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Giuseppe Nicotera Gianluca Sferrazza Annalucia Serafino Pasquale Pierimarchi |
spellingShingle |
Giuseppe Nicotera Gianluca Sferrazza Annalucia Serafino Pasquale Pierimarchi The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach Frontiers in Medicine regulatory tools European medicines agency adaptive pathways HTA bodies iterative development |
author_facet |
Giuseppe Nicotera Gianluca Sferrazza Annalucia Serafino Pasquale Pierimarchi |
author_sort |
Giuseppe Nicotera |
title |
The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach |
title_short |
The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach |
title_full |
The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach |
title_fullStr |
The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach |
title_full_unstemmed |
The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach |
title_sort |
iterative development of medicines through the european medicine agency's adaptive pathway approach |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Medicine |
issn |
2296-858X |
publishDate |
2019-06-01 |
description |
The development of novel regulatory tools such as adaptive clinical trial design and utilization of real-world evidence are topics of high interest. Recently, the European Medicines Agency (EMA) introduced the Adaptive Pathways (AP) that represents an innovative tool in healthcare systems allowing the early dialogue with multiple stakeholders on promising and innovative medicinal products in areas with an high unmet medical need. The innovative aspect in the AP is the early involvement of several stakeholders such as pharmaceutical industry, the Academia, Health Technology Assessment (HTA) bodies, and patient representatives bringing their real experience with the disease and their expectations about the treatment. AP is not a new licensing tool but an opportunity for a very early discussions, before starting the phase II studies, among all stakeholders, including regulators, companies, HTA bodies, and patient representatives on a new potential medicine in areas of high unmet medical need. The aim of this paper is to describe the evolution of the AP approach from the beginning of the pilot project to date, highlighting major advances, and achievement at European level. |
topic |
regulatory tools European medicines agency adaptive pathways HTA bodies iterative development |
url |
https://www.frontiersin.org/article/10.3389/fmed.2019.00148/full |
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