- What is the Australian New Zealand Clinical Trials Registry (ANZCTR)?
The ANZCTR is a Primary Registry in the World Health Organisation (WHO) Registry Network. It accepts
trials for registration from all countries and from the full spectrum of therapeutic
areas including trials of pharmaceuticals, surgical procedures, preventive measures,
lifestyle, devices, treatment and rehabilitation strategies and complementary therapies.
The registry was established in 2005 at the National Health and Medical Research Council (NHMRC) Clinical Trials
Centre, University of Sydney, with $1.5 million in funding from the Australian
Government, through a NHMRC Enabling Grant. The management team is lead by Professor
The ANZCTR is overseen by an Advisory Committee with wide representation from a
variety of stakeholders including government, clinicians, the research community,
journal editors, the pharmaceutical industry and regulator, and consumers.
- What is the purpose of the ANZCTR?
In the past decade there has been a worldwide initiative to make public all clinical
trials being conducted.
With the establishment of the ANZCTR, individuals are now able to find out which
clinical trials are taking place across all areas of health - new drugs, treatments,
therapies, surgical procedures and new medical devices.
People interested in participating in a clinical trial and doctors investigating
relevant trials for their patients now have access to a reputable and comprehensive
on-line register showing what trials are occurring and where.
Health professionals are able to investigate the evidence behind new treatments,
therapies or drugs arising from a trial listed by the ANZCTR.
The ANZCTR helps researchers identify gaps in their own research and prevent unnecessary
duplication of clinical trials. Having access to information about trials under
way provides valuable insights for researchers.
- Why is the ANZCTR important?
There is growing recognition internationally of the need to record the existence
of clinical trials so that a true picture of the evidence for a particular new treatment,
drug, medical device or therapy is publicly available. The registry helps to provide
patients and health practitioners with access to information about trials that they
may consider important for their future treatment choices or trials in which they
may be interested to participate.
The registry will help provide patients and health practitioners with access to
information about trials that they may consider important for their future treatment
choices or trials in which they may be interested to participate.
Prior registration is now a condition of publishing trials research. As of the 1st
July 2005 the International Committee
of Medical Journal Editors (ICMJE, which includes, among many others, editors
of the Medical Journal of Australia, the Lancet and the New England Journal of Medicine)
will only consider clinical trials for publication in their journals if they are
included on an authorised register (such as the ANZCTR) at the trial's inception.
- What are the benefits of a clinical trials registry?
A clinical trials registry increases the efficacy of the current clinical trial
- greater efficiency by reducing unnecessary duplication of research effort, because
people planning a new trial will be aware of all the other trials that exist.
- potential for higher recruitment rates of clinical trial participants (especially
for rare or life-threatening conditions), thereby increasing the chances of a successful
outcome from some clinical trials.
- better compliance: a register identifies trials being conducted so that disclosure
of results may be more timely.
- added value to research results, by providing a reliable and unbiased source of
information about trials for systematic reviews, prospective meta-analyses and evidence-based
- improving available evidence to inform treatment practice and health care
- How does the registry benefit patients?
- Patients and health professionals now have free access to a searchable, accessible
and comprehensive Australian New Zealand Clinical Trials Registry.
- They will also have greater assurance that all clinical trials results are reported,
including those with adverse findings.
- NOTE: The information provided on the ANZCTR website is designed to support, not
to replace, the relationship that exists between a patient/site visitor and his/her
- How can I access the registry?
Information about trials registered on the ANZCTR is available to the public and
can be searched via the ANZCTR website www.anzctr.org.au
by clicking on the 'Trial search' button. The search function allows you to conduct
a 'basic search' where you can enter in text word(s) or phrases and the system will
search for that text word/phrase in all fields on the trial registration form. You
can also conduct an advanced search that allows you to search specific fields on
the registration form. Once you find a trial that is relevant to you, you will be
able to contact the person listed as the 'public contact' on the trial record for
Please note that NOT ALL clinical trials being conducted in Australia and New Zealand
are registered on the ANZCTR as clinical trial registration is not mandatory at
present. All trial information published on the ANZCTR website has been provided
by the registrant/sponsor of each trial. The ANZCTR, therefore, is not responsible
for the data accuracy of the trial information. We advise that any trial information
you retrieve from the ANZCTR website should be discussed with your health care professional.
- What studies need to be registered?
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. If in doubt about whether to register or not, registration is recommended.
- When should studies be registered?
Trials should be registered before enrolment of the first patient.
In cases where retrospective registration is required (i.e. the trial has, at the
time of registration, already begun recruitment, ended recruitment or has since
been completed), the ANZCTR will allow registration however registrants should double-check
requirements with their respective Ethics Committees.
* In order to fulfil this prospective registration requirement, we recommend that
you commence the registration process at least 10 days prior to the anticipated
recruitment start date.*
- Who is responsible for registering a trial?
The trial's Sponsor or an appropriate representative is responsible for registering
a trial. This is "an individual, company or institution or organisation which takes
responsibility for the initiation, management and/or financing of a clinical trial"
(as defined by the NHMRC
and Therapeutic Goods Administration
(TGA)). An appropriate representative of a Sponsor is any individual with delegated
authority to agree to the conditions of registration on behalf of the Sponsor.
Sponsors include (as defined by clinicaltrials.gov):
- (Company) Sponsors legally responsible for conducting clinical trials
- Governmental or international agencies conducting or supporting clinical trials
- Lead principal investigators who are responsible for conducting and coordinating
the overall clinical investigation. For multi-site studies, trial data should be
submitted only once. (i.e. trial data should not be submitted from every study location).
The Sponsor is responsible for
- registering the trial
- 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
- How do I register a trial?
Trial registration can be completed online at: www.ANZCTR.org.au
First time users need to create a login name and password. Using the 'Register Trial'
button will take the registrant to the screens that need to be completed. This includes
basic trial information such as the types of participants, the interventions being
tested and the outcomes to be assessed. Other information required includes details
of the study design, sample size and contact information. Each field has an information
button ' ' to assist registrants in entering the correct data. Once each screen
is completed, the registrant should click on the 'Save and Review' button to ensure
that all information is saved on the database. Once all the mandatory information
has been entered, the registrant should click on the 'Review' button at the bottom
right hand corner. Once the registrant is satisfied with the details provided, they
should then click on the 'Submit' button.
Following submission of the data, ANZCTR staff will check the data submitted and
query the registrant should anything need clarification. Once any queries are confirmed,
trials are officially 'registered' and allocated a unique registration number (ACTRN).
Both date of submission and date of registration are recorded.
Information on each trial (including patient accrual, trial and publication status)
should be updated regularly.
- What is recorded on the registry?
The registry records a trial's:
- main design features
- sample size and recruitment status
- treatments under investigation
- outcomes being assessed
- principal investigators
- contact details for specific trial information
- Does the registry meet the requirements of the International Committee
of Medical Journal Editors (ICMJE)?
There is considerable international pressure to develop national clinical trials
- Many of the editors of the most prestigious international journals have announced
that from 1st July 2005 that they will not publish articles reporting on unregistered
- In response to this and the strongly negative public reaction to the lack of full
disclosure of the adverse affects of some drugs, the Americans and British have
recently developed national registries.
- In 2007 the World Health Organisation (WHO) developed the International Clinical Trials Registry Platform (ICTRP) which
links the national registers, providing an international resource on clinical trials.
The ICTRP Search Portal can be found at www.who.int/trialsearch.
The Australian Clinical Trials Registry is consistent with the requirements set
out by the ICMJE and WHO trials portal. In 2006, the ANZCTR became an ICMJE acceptable
registry and in early 2007, the ANZCTR became one of the first Primary Registers in the WHO Register Network.
- Will patients or health care providers have to pay to access the
information or register a trial?
No, access is free to the trial information that is publicly available. There is
no charge for registering a trial.
- What is the history of the registry and what are the plans for
Since its inception in 2005, the ANZCTR has undergone a number of developmental
The registry will be further developed over the next few years in order to improve
various functions and make the site more user-friendly.
Phases of ANZCTR development:
This phase of development was completed by the end of June 2005 to ensure that Australian/New
Zealand trialists were able to meet the ICMJE deadline of 1st July 2005. The web
site and the "back end" database were developed within a very short period of time.
Opportunities for consultation were limited and this site was compiled primarily
to meet an immediate need. Therefore, various problems arose requiring some simple
modifications to the web site and database. Plans were also made to develop a more
sophisticated search screen and a "query" system to facilitate administration of
In November 2005 a meeting of the WHO ICTRP Advisory Board was held at which decisions
were made regarding:
- the standardisation of a minimum dataset of 20 items required for registration
- certification of registers
- a globally unique trial numbering system
- a portal for searching registers worldwide
- The ANZCTR data fields were then amended, as required, to comply with the agreed
A detailed audit trail facility was developed and implemented in 2007 to enable
the registrants to log on and update selected fields, with a record kept of the
field changed and the nature of the change.
A stakeholder consultation meeting was held in 2009 to determine what the users
of the ANZCTR want in their registry.
A detailed project plan was developed based on the stakeholder consultations and
feedback on Phases 1 to 4. Long term sustainable funding and management structures
continue to be investigated and implemented.
Other initiatives involving the ANZCTR
The World Health Organisation (WHO) has developed an international system for assigning
a unique trial registration number (UTN) which in 2009 was incorporated into the
ANZCTR system. See 'What is the UTN?' below.
In May 2007, the WHO developed an international clinical trials search portal at
The ANZCTR is linked to this portal so that people can investigate what trials are
occurring overseas. This will not only help researchers and health professionals
get a better picture of what is happening in their area of expertise overseas, but
will have important benefits for patients and their health care providers.
- What is the UTN?
Universal Trial Number (UTN) is a unique number which aims to facilitate
the unambiguous identification of clinical trials registered in WHO Primary Registries
and displayed on the WHO International Clinical Trials Registry Platform's (ICTRP)
Search Portal. It is not a registration number.
A UTN should be obtained early in the history of the trial and should:
- become permanently attached to the trial
- be used whenever information about the trial is communicated
- become part of the trial's identity
- be documented in the trial protocol
- be submitted every time the trial is registered
To obtain a UTN please go to
http://apps.who.int/trialsearch/utn.aspx, and enter in your name, email
and organisation. WHO will then send you an email with a link to confirm your request.
Once confirmed you will receive a second email from WHO with your UTN details.
- Are there any other Australian/New Zealand clinical trials registries?
The ANZCTR has imported data from, and exported data to, various alliance organisations,
including the Cochrane Renal Group and Multiple Sclerosis Research Australia (MSRA).
Other Australian and New Zealand groups maintain independent registers on specific
disease areas, including:
In addition, the Therapeutic Goods
Administration (TGA) maintains an independent register of ongoing trials
on therapeutic goods in Australia.
- Are there other international registries?
The first call for comprehensive registration of clinical trials was made over 20
years ago. However, a major catalyst for action was the announcement by the International
Committee of Medical Journal Editors (ICMJE) in September 2004 that all 11 ICMJE
member journals would require, as a condition of consideration for publication,
registration in a publicly accessible trials registry. Trials must be registered
before the first subject is enrolled, a policy applying to any clinical trial commencing
enrolment after the 1st of July 2005. For trials that began enrolment prior to this
date, the ICMJE member journals required registration by the 13th of September 2005.
The ICMJE has established specific criteria that registries are required to fulfil
before they will be considered as an acceptable registry. A list of trial registries
recognised by the ICMJE as acceptable registries are available at the following
In parallel with the ICMJE initiatives, the World Health Organization (WHO) launched
its International Clinical Trial Registry Platform (ICTRP) in August 2005. The ICTRP's
main objectives are to ensure that all clinical trials are registered and can be
easily found as well as settings standards for good registry practice.
In May 2006, the ICTRP recommended that research institutions and companies register
all medical studies that test treatments on human beings, including the early phase
studies, whether they involve patients or healthy volunteers. The ICTRP also recommended
that a minimum 20 key details about a trial (WHO Trial Registration Data Set) be
disclosed at the time studies are about to commence.
In May 2007, the ICTRP launched its global search portal (http://www.who.int/trialsearch). To date, 11 trial registries
are contributing data to the search portal (http://www.who.int/ictrp/network/primary/en/index.html).
From the portal, users can search for trials across these 11 registers as well as
link back to the original record in the primary register. It is likely that more
registers will contribute data to the portal in the near future.
Currently, there are many clinical trials registries around the world, often working
in isolation. The ICTRP is seeking to bring participating registers together in
a global network to assist them share their experiences, which will minimise duplication
of effort, and to ensure common standards are adopted to make searching across registries