Registration of Clinical Trials: Challenges for Global Regulation

Journal of Law and Medicine, Vol. 17, No. 1, pp. 82-94, 2009

Sydney Law School Research Paper No. 10/55

Posted: 24 May 2010  

Belinda Bennett

Queensland University of Technology

Claire Deakin

Children's Medical Research Institute (CMRI)

Date Written: May 23, 2010

Abstract

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, K32

Suggested Citation

Bennett, Belinda and Deakin, Claire, Registration of Clinical Trials: Challenges for Global Regulation (May 23, 2010). Journal of Law and Medicine, Vol. 17, No. 1, pp. 82-94, 2009; Sydney Law School Research Paper No. 10/55. Available at SSRN: https://ssrn.com/abstract=1614590

Belinda Bennett (Contact Author)

Queensland University of Technology ( email )

Level 4, C Block Gardens Point
2 George St
Brisbane, QLD 4000
Australia

Claire Deakin

Children's Medical Research Institute (CMRI) ( email )

214 Hawkesbury Rd
Westmead, NSW 2145
Australia

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