Early Access to Medicines Scheme: real-world data collection.

Data Collection / legislation & jurisprudence Drug Approval / legislation & jurisprudence Health Services Accessibility / legislation & jurisprudence Humans United Kingdom

Journal

Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391

Informations de publication

Date de publication:
12 2019
Historique:
received: 10 04 2019
revised: 04 06 2019
accepted: 17 06 2019
pubmed: 23 6 2019
medline: 10 7 2020
entrez: 23 6 2019
Statut: ppublish

Résumé

Real-world data (RWD) generated during the pre-approval phase could be supplementary to primary clinical trial outcomes; however, as we discuss here, a data collection framework is needed to ensure the validity and applicability of these data.

Identifiants

DOI: 10.1016/j.drudis.2019.06.009 PMID: 31228615
pubmed: 31228615
pii: S1359-6446(19)30083-2
doi: 10.1016/j.drudis.2019.06.009
pii:
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

2231-2233

Informations de copyright

Copyright © 2019 Elsevier Ltd. All rights reserved.

Auteurs

Hok Pang (H)

Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK.

Meng Wang (M)

Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK.

Christopher Kiff (C)

Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK.

Mira Soni (M)

Evidera, London, UK.

Dara Stein (D)

Evidera, London, UK.

David Tyas (D)

Bristol-Myers Squibb Pharmaceuticals Ltd., London, UK. Electronic address: David.Tyas@bms.com.

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Classifications MeSH

questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Early Access to Medicines Scheme: real-world...
questionsmedicales.fr › Sciences sociales › Sociologie › Agrément de médicaments › Early Access to Medicines Scheme: real-world...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Accessibilité des services de santé › Early Access to Medicines Scheme: real-world...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Early Access to Medicines Scheme: real-world...
questionsmedicales.fr › Régions géographiques › Europe › Royaume-Uni › Early Access to Medicines Scheme: real-world...