Newsletter Issue 7, Dec 2011
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
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
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.
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.
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:
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.