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News & Views Ethical Standards For Clinical Trials Conducted In Third Countries: The New Strategy of the European Medicines Agency.

Authors :
Altavilla, Annagrazia
Source :
European Journal of Health Law; Jan2011, Vol. 18 Issue 1, p65-75, 11p
Publication Year :
2011

Abstract

Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
09290273
Volume :
18
Issue :
1
Database :
Complementary Index
Journal :
European Journal of Health Law
Publication Type :
Academic Journal
Accession number :
58701070
Full Text :
https://doi.org/10.1163/157180911X546129