ANZCTR newsletters

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

Articles of interest

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.pdf ). 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.

Version 3 of the ANZCTR database is now up and running!

We have now updated the ANZCTR with additional functions that allow registrants to update trial information at any time. A more comprehensive search function has also been implemented in this new version. The ANZCTR registration form has slightly changed to be in line with the WHO guidelines and to allow the new search function to be more precise and informative.

The ANZCTR is being developed to its full functionality in stages (see About ANZCTR ) so there may be more changes in response to user evaluation and feedback over the coming months.

Please provide us with feedback or contact us directly should you wish to ask any questions about submitting your trial or accessing information on the ANZCTR.

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.