Registration of Clinical Trials: Challenges for Global Regulation
University of Sydney - Faculty of Law
Children's Medical Research Institute (CMRI)
May 23, 2010
Journal of Law and Medicine, Vol. 17, No. 1, pp. 82-94, 2009
Sydney Law School Research Paper No. 10/55
In 2004 the International Committee of Medical Journal Editors (ICMJE) issued a statement indicating that from 1 July 2005 registration in a publicly accessible trials registry would be a condition of publication in an ICMJE member journal. The World Health Organisation is coordinating the International Clinical Trials Registry Platform (ICTRP) as a means of providing a standardised framework for registration. This article considers the practical challenges and opportunities that arise from these developments and considers the relevance of trial registration for women and minorities and for developing countries.
Keywords: health law, policy, clinical trials
JEL Classification: K10, K30, K32Accepted Paper Series
Date posted: May 24, 2010
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