Anavex Life Sciences Corp (AVXL)

[F1ash]

The AU government is fully aware of this irregularity and is allowing it to happen. There must be a reason.

Could it be they see a new trial as redundant and not needed at this point?

Seriously????

Is registration of clinical trials mandatory in Australia or New Zealand?

Registration of clinical trials is not legally required in Australia or New Zealand. However, there are a number of initiatives that seek to encourage and enforce prospective registration:
In 2004 the International Committee of Medical Journals Editors (ICMJE, including editors of the Medical Journal of Australia, Lancet, New England Journal of Medicine and others) declared that they would not consider a trial for publication without evidence that it had been registered in a publicly accessible trials registry prior to enrolment of the first participant.

The Declaration of Helsinki now explicitly states that "every clinical trial must be registered in a publicly accessible database before recruitment of the first subject". The Declaration is the cornerstone document guiding the ethical conduct of research in humans by physicians.
The World Health Organization (WHO) considers the registration of all interventional trials to be "a scientific, ethical and moral responsibility" (who.int/ictrp/en/).
Australia has also endorsed prospective trial registration in two key documents which guide the conduct of Human Research Ethics Committees and the conduct of Australians undertaking research in humans.

The 2007 revision of the National Statement on Ethical Conduct in Human Research contains clause 3.3.12 which states "Before beginning the clinical phase of the research, researchers should register clinical trials in a publicly accessible register".

The 2007 revision of the Australian Code for the Responsible Conduct of Research which was jointly issued by the NHMRC, the Australian Research Council and Universities Australia also contains a clause regarding prospective trial registration. Clause 4.10 of this document states that "researchers must register clinical trials with a recognised register to promote access to information about all clinical trials."

Ethics committees are increasingly requiring prospective registration as a requirement of ethical approval.

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Who is responsible for registering a trial?

The trial's sponsor or an appropriate representative is responsible for registering a trial. The sponsor is defined by the NHMRC and Therapeutic Goods Administration (TGA) as "an individual, company or institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial". 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


http://www.anzctr.org.au/faq.aspx#r1