Ethical Standards for Clinical Trials Conducted in Third Countries: The New Strategy of the European Medicines Agency
European journal of health law 2011 Jan; 18(1): 65-75
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.
Showing items related by title, author, creator and subject.
Safeguarding Clinical Trials. Efforts Are Underway to Modernize Clinical Trial Standards and Normalize Regulations to Facilitate International Collaboration. but as the European Union's Clinical Trials Directive Shows, a One-Size-Fits-All Regulatory Strategy May Be Easier to Conceive Than to Implement Unknown creator (2007-02)
Effect of European Clinical Trials Directive on Academic Drug Trials in Denmark: Retrospective Study of Applications to the Danish Medicines Agency, 1993-2006 Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Peterson, Lene Grejs; Anderson, Elin; Poulson, Henrik Enghusen (2008-01-05)