Australian New Zealand Clinical Trials Registry

Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal) ANZCTR Newsletter Issue 3, Dec 2007

ANZCTR User Survey ANZCTR Statistics

International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR How to register a trial How to update a trial

About ANZCTR

The Australian New Zealand Clinical Trials Registry (ANZCTR) is an on-line register of clinical trials being undertaken in Australia and New Zealand. It is funded for 5 years by an National Health and Medical Research Council (NHMRC) Enabling Grant..

The ANZCTR includes trials from the full spectrum of therapeutic areas trials of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies and complementary therapies. It has coverage all clinical trials involving Australian/New Zealand researchers or participants. Trials that do not involve Australian/New Zealand researchers or participants will be accepted if there is not a more appropriate national registry with which they should be lodged.

The ANZCTR aims to:

be a comprehensive, prospective, national register of clinical trials
include trials of any health care interventions
make information on ongoing trials readily accessible
increase participation in ongoing clinical trials
provide a reliable and unbiased source of information for systematic reviews, prospective meta-analyses and evidence-based guidelines

The ANZCTR has been designed to comply with the requirements of the International Committee of Medical Journal Editors (ICMJE), although there is currently no formal certification process. The ANZCTR is actively involved in the international platform for trials registers (ICTRP) proposed by the WHO and has also taken advantage of the specifications published online by clinicaltrials.gov

Key points about the ANZCTR:

At this point in time, all data submitted is made publicly available
Registration is voluntary, but if a Sponsor chooses to register a trial, certain fields are mandatory
Registration is free of charge
Responsibility for registration lies with the Sponsor
- A Sponsor is defined by the NHMRC and TGA as "an individual, company or institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial".
- It is the Sponsor's responsibility to ensure that the information submitted is accurate and up-to-date.

Phased development of the ANZCTR:

Although the need for a national clinical trials register has been recognised for many years, the establishment of the ANZCTR was expedited by the ICMJE call for trials registration for new trials from 1st July 2005. Consequently the first version of the ANZCTR was developed within a very short time period, and further improvement of the registry will be accomplished by phased development over several years (please see FAQ What are the future plans for the registry?).