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ANZCTR newsletters

ANZCTR Newsletter Issue 8, Dec 2013

ANZCTR Newsletter Issue 7, Dec 2011

ANZCTR Newsletter Issue 6, Dec 2010

ANZCTR Newsletter Issue 5, Dec 2009

ANZCTR Newsletter Issue 4, Dec 2008

ANZCTR Newsletter Issue 3, Dec 2007

ACTR Newsletter Issue 2, Dec 2006

ACTR Newsletter Issue 1, Dec 2005

Registration as a tool to increase research value

This article, published in the Lancet, advocates trial registration as a tool to increase research value. More...

Trial registration now a condition for ethical approval in the UK

Ian Chalmers discusses this significant milestone in his BMJ editorial. More...

Testing Transparency

An international movement to boost transparency in clinical trials is gathering momentum. Iain Chalmers, who has championed these issues for many years, talks to Fiona Fleck. More...

Registration requirement for project grant applications

As announced in section 6.3 of the "NHMRC Project Grants Funding Policy" for 2012, all NHMRC funded clinical trials must be registered in the Australian New Zealand Clinical Trials Registry (ANZCTR), or equivalent, prior to commencement of the clinical phase.

Australian Cancer Trials

The Australian Cancer Trials website (http://www.australiancancertrials.gov.au/) was launched in November 2010, containing information on over 1000 Australian and international cancer clinical trials uploaded on a regular basis from the ANZCTR database. The website is designed for and aimed towards the Australian consumer, by making clinical trials information more accessible for patients and their healthcare teams, and also in helping facilitate participation in these studies.

Articles of interest

BMJ Editorial: All trials must be registered and the results published.

Biggest cancer killers lack adequate research

Adding value to clinical trial registries: insights from Australian Cancer Trials Online, a website for consumers.

Landscape of cancer clinical trials in Australia: using trial registries to guide future research.

Quality of Registration of Clinical Trials

Trials registration now part of the revised CONSORT statement

ANZCTR has met the requirements of the ICMJE's trials registration policy and is now an ICMJE acceptable registry. More...

Issues in the Registration of Clinical Trials [JAMA 297(19); 2112-2120, 2007] More...

US legislation developments: In March 2007, US Congress Representatives Henry A. Waxman and Edward J. Markey introduced counterpart legislation to the Enzi-Kennedy US Senate bill which intends to further enhance the proposed mandatory clinical trial registry and results database. More...

ICMJE requirements update

There have been several enquires about whether the ANZCTR fulfils all the requirements of the International Committee of Medical Journal Editors (ICMJE) and thus whether trials registered on the ANZCTR before the specified deadlines (any new trials commencing after 1st July 2005, and before 13th September 2005 for ongoing trials) would be eligible for publication in the ICMJE journals.

The ANZCTR contains all the mandatory data fields specified by the ICMJE, is publicly owned and publicly accessible. Before allowing trial registration, the ANZCTR staff check each trial submission to ensure that each field contains meaningful information. The ANZCTR has met the requirements of the ICMJE's trials registration policy and is now an ICMJE acceptable registry ( http://www.icmje.org/faq.html). Trials registered with the ANZCTR by the specified dates will be eligible for publication in ICMJE journals.

Prior to the 13th September 2005 ICMJE deadline for ongoing trials, there was a huge influx of registrants attempting to submit their trials to the ANZCTR. As the interim system still had several "bugs" and due to the overwhelming numbers, there were a number of trials that submitted, or attempted to submit, their trial before the deadline but whose actual date of registration was after 13th September 2005. The ICMJE has provided us with the information below regarding how their journals will deal with trials that began before 1st July 2005 but were not registered by 13th September 2005:

"Despite good faith by many investigators and sponsors, we understand that not all ongoing trials have been able to meet the September 13, 2005 deadline. Legitimate delays may occur for a number of reasons, including delayed awareness of the policy and implementation issues. In certain circumstances, editors will consider trials registered after September 13, 2005 as compliant with our policies. Individual editors will make decisions about exceptions on a case-be-case basis. Please direct inquiries to the editor of the journal to which you will submit the manuscript."

Both the date submitted and the date actually registered are recorded by the ANZCTR (if you "view" your trial, you will see both dates under the "registration" section so you can provide this information to journal editors should it be required.

In June 2007, the ICMJE announced that they will be expanding their definition of the types of trials that require registration by adopting the WHO's definition of 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'. This expanded definition requires preliminary trials designed to study pharmacokinetics or major unknown toxicity (phase 1 trials) to be registered. The ICMJE will begin to implement the WHO's definition of clinical trials for all trials that begin enrollment on or after July 1, 2008.

WHO establishes an International Clinical Trials registry Platform (ICTRP)

The World Health Organisation (WHO) held a consensus meeting in New York in October 2004 that brought together government research institutions, pharmaceutical industry representatives, journal editors, researchers, and other leading experts to identify substantial common ground regarding trial registration. A general consensus was reached regarding the need for worldwide clinical trial registration. The so called "New York Statement 2004" noted the following:

The need for a global approach to clinical trials registration

  • Trials unambiguously identified
  • Consensus needed on which trials; data; timing and disclosure of results
  • One-stop search portal; publicly available
  • System is simple, effective, efficient
  • Capacity built where appropriate

The ICTRP can be accessed via: www.who.int/ictrp/en/ to develop an international, electronic search portal through which registries around the world can be located and accessed. This search portal became functional in May 2007. A second objective of the ICTRP is to establish processes for recognising registers of certain standards as Primary Registers. There are also plans for the development of a worldwide unique trial ID numbering system.

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