The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. The ANZCTR was established in 2005 and is part of a worldwide initiative to make public all clinical trials being conducted.
Although registration of clinical trials is not legally required in Australia or New Zealand, there are a number of initiatives that seek to encourage and enforce prospective registration including:
- In 2004 the International Committee of Medical Journals Editors (ICMJE, including editors of the Medical Journal of Australia, Lancet, New England Journal of Medicineand others) declared that they would not consider a trial for publication without evidence that it had been registered in a publicly accessible trials registry prior to enrolment of the first participant. The ANZCTR became an ICMJE acceptable registry in 2006.
- The ‘Declaration of Helsinki’now explicitly states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject”. The Declaration is the cornerstone document guiding the ethical conduct of research in humans by physicians.
- The World Health Organization (WHO) considers the registration of all interventional trials to be “a scientific, ethical and moral responsibility”.
- Australia has also endorsed prospective trial registration in two key documents, the ‘National Statement on Ethical Conduct in Human Research’ and the ‘Australian Code for the Responsible Conduct of Research’. Ethics committees are also increasingly requiring prospective registration as a requirement of ethical approval.
Registering a clinical trial
Studies that meet the WHO/ ICMJE 2008 definition of a clinical trial should be registered. That is, any research study that prospectively assigns human participants or groups of humans to one or more health related intervention to evaluate the effects on health outcomes. Medical interventions include any intervention used to modify a health outcome and include drugs, surgical procedures, devices, behavioural treatments, etc. Studies should be registered before enrolment of the first participant. The ANZCTR also accepts observational studies for registration.
Responsibility for registering a clinical trial on the ANZCTR lies with the trial sponsor or their appropriate representative. The sponsor is responsible for:
- registering the trial (there is no registration fee involved)
- the accuracy and completeness of registered data, and for indicating when selected non-mandatory items should be suppressed from public view
- ensuring that information on any one trial is submitted only once
- communicating with trial collaborators regarding the registration status of the trial, and the registration number
- ensuring information on the registered trial is kept up-to-date
The clinical trial information that is recorded on the ANZCTR includes:
- main design features
- sample size and recruitment status
- treatments under investigation
- outcomes being assessed
- principal investigators
- contact details for specific trial information
The ANZCTR was one of the first three Trial Registries to be recognised by the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) as a Primary Registry and is the only Primary Registry in the WHO Registry Network in Australia/New Zealand. There are currently 15 Primary Registries in the World Health Organization Registry Network.
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This article was written by Ric DeGaris from our Clinical Development team.