Current Sections: Research FundingRegistering clinical trials
In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that member publications would only consider clinical trials for publication if the trial had been registered on a trials registry before recruitment of the first participant. Member journals of ICMJE include many major medical publications overseas (such as New England Journal of Medicine, Lancet, JAMA) as well as the New Zealand Medical Journal.
This policy came into force on 1 July 2005 and member journals of the ICMJE will no longer accept clinical trials for publication unless the trials have been prospectively registered with a public domain registry that is accessible online and contains the dataset outlined by the WHO. The policy applies to all studies that meet the WHO/ ICMJE 2008 definition of a clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. Trials should be registered by the sponsor, defined as "An individual, company or institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial". For publicly or charitably funded trials, the sponsor would be the principal investigator.
The Australian New Zealand Clinical Trials Registry (ANZCTR) is free-of-charge, meets the ICMJE criteria and is now live and accepting online registrations at www.anzctr.org.au. All clinical trials involving Australian/New Zealand investigators or participants, in all areas of health and testing all forms of interventions should be registered on the ANZCTR. New trials should register before the first participant is randomised. For multi-site studies, trial data should be submitted only once. (ie. trial data should not be submitted from every study location). Trials with recruitment sites in New Zealand are identifiable within the register to facilitate research on New Zealand entries.
The ANZCTR was established in 2005 at the Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney and is now funded by the HRC and the NHMRC. The HRC is the coordinating agency for New Zealand and will work closely with the NHMRC. It is anticipated that the clinical trials registration process and ethics committee approval will be linked.
Enquiries about the registration process should be directed to Sandra Reid at the HRC; email: sreid@hrc.govt.nz, or to Andrew Jull, Research Fellow, Clinical Trials Research Unit, The University of Auckland; email: a.jull@auckland.ac.nz, phone 09 373 7599 ext 84744.
Last Updated : 09 October 2009 16:07:01.
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