Registration of clinical trials: challenges for global regulation.
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.
Bennett
Belinda
B
Centre for Health Governance, Law and Ethics, Faculty of Law, University of Sydney, Australia. b.bennett@usyd.edu.au
Deakin
Claire
C
D002986:Clinical Trials as Topic; D006801:Humans; D012042:Registries / Q000592:standards*; D035842:Research Subjects