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 John Simes.

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.

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.

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.

A clinical trials registry increases the efficacy of the current clinical trial effort through:

• 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 guidelines.
• improving available evidence to inform treatment practice and health care

• 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 physician.

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 more information.

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.

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.

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.*

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

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.

The registry records a trial's:

• objectives
• main design features
• sample size and recruitment status
• treatments under investigation
• outcomes being assessed
• principal investigators
• contact details for specific trial information

There is considerable international pressure to develop national clinical trials registers.

• 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 clinical trials.
• 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.

No, access is free to the trial information that is publicly available. There is no charge for registering a trial.

Since its inception in 2005, the ANZCTR has undergone a number of developmental phases.

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:

Phase 1
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 the ANZCTR.

Phase 2
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 international standards

Phase 3
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.

Phase 4
A stakeholder consultation meeting was held in 2009 to determine what the users of the ANZCTR want in their registry.

Phase 5
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 http://www.who.int/trialsearch. 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.

The 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.

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:

• Australian and New Zealand Breast Cancer Trials Group Register (ANZBCTG)
• Victorian Cancer Trials Link (Cancer Council Victoria and Victorian Cooperative Oncology Group)

In addition, the Therapeutic Goods Administration (TGA) maintains an independent register of ongoing trials on therapeutic goods in Australia.

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 (http://www.icmje.org/update_may05.html) 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 link: http://www.who.int/ictrp/network/primary/en/index.html

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 easier.

• The ANZCTR website does not host or receive funding from advertising.