Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?


Journal

Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741

Informations de publication

Date de publication:
05 2019
Historique:
received: 22 01 2018
accepted: 01 05 2018
pubmed: 15 6 2018
medline: 15 2 2020
entrez: 15 6 2018
Statut: ppublish

Résumé

Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.

Identifiants

pubmed: 29901216
doi: 10.1002/cpt.1121
pmc: PMC6585618
doi:

Substances chimiques

Drugs, Investigational 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

1148-1155

Informations de copyright

© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Références

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pubmed: 25669457
BMJ. 2016 Aug 16;354:i4437
pubmed: 27531201
Front Pharmacol. 2018 Mar 27;9:280
pubmed: 29636692
Clin Pharmacol Ther. 2014 Nov;96(5):559-71
pubmed: 25006877
Nat Rev Drug Discov. 2008 Oct;7(10):818-26
pubmed: 18787530
Front Pharmacol. 2016 Sep 28;7:305
pubmed: 27733828
Eur J Clin Pharmacol. 2005 May;61(3):231-6
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Ther Innov Regul Sci. 2016 May;50(3):347-354
pubmed: 30227070

Auteurs

Hans-Georg Eichler (HG)

European Medines Agency (EMA), London, UK.

Nicola Bedlington (N)

European Patients Forum, Brussels, Belgium.

Mathieu Boudes (M)

EURORDIS-Rare Diseases Europe, Paris, France.

Jacoline C Bouvy (JC)

National Institute for Health and Care Excellence (NICE), London, UK.

André W Broekmans (AW)

Lygature, Utrecht, The Netherlands.

Francesca Cerreta (F)

European Medines Agency (EMA), London, UK.

Stuart D Faulkner (SD)

Centre for the Advancement of Sustainable Medical Innovation (CASMI), Headington Oxford, UK.

Susan R Forda (SR)

Eli Lilly and Company, London, UK.

Angelika Joos (A)

MSD (Europe) Inc, Brussels, Belgium.

Yann Le Cam (Y)

EURORDIS-Rare Diseases Europe, Paris, France.

Mark H Mayer (MH)

Eli Lilly and Company, Indianapolis, Indiana, USA.

Vinciane Pirard (V)

Sanofi-Genzyme, Brussels, Belgium.

Solange Corriol-Rohou (S)

Astra Zeneca, Paris, France.

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Classifications MeSH