The National
Clinical Trials Registry aims to provide a complete and comprehensive
catalogue of clinical trials in which Australians are participating.
The register currently includes information
on cancer trials only, although the registry is expanding to include
perinatal trials. It allows searchers to identify unpublished and
ongoing cancer clinical trial research and is a resource for all
those with an interest in health care researchincluding health
care providers, consumers and funders.
Aims of the National Clinical Trials Registry
The aims of the registry are to:
provide a general description of clinical trials research
identify clinical trials planned and in progress
enable protocol details to be registered before the results
are known
provide a means for selecting trials for meta-analysis and
review articles
ensure that trials are ethical and worthwhile
in the long term, improve clinical care and clinical practice
Why is a registry required?
Recent trends in the practice of medicine have emphasised the importance
of basing treatment decisions on solid evidence that those treatments
are effective.
The highest level of evidence comes from systematic
reviews of all relevant randomised trials or, when this is not available,
evidence from at least one properly designed randomised controlled
trial.
Benefits of registration
Prospective registration of clinical trials will:
improve communication among researchers by providing accessible
information for those considering designing or participating in
a clinical trial
encourage collaborative research, and hence stimulate recruitment
to clinical trials, which will increase the likelihood of a trial's
success
reduce repetition, by making details of established research
available to those in the process of designing a trial
allow the conduct of methodological research, to investigate
the ways in which trials are undertaken
allow clinical trials in Australia to be included in international
registries of clinical trials
assist funding bodies in allocating funds to clinical trials
research, by identifying and describing work in progress.
What is recorded by the registry?
The registry records:
a trial's objectives
a trial's main design features
sample size and statistics
the treatments under investigation
the outcomes being assessed
the principal investigator's contact details.
Registered trials are allocated a registration
number, and the date of registration is recorded. Information on
each trial (including accrual, trial status and publication status)
is updated annually.
Confidentiality
The approval of the principal investigator
is obtained before a trial is registered. As some investigators
may want to avoid disseminating a particular idea, treatment regimen
or design feature before it is formally published, they can choose
to restrict access to sensitive details. Registration 'in camera'
enables all (or selected) details to be registered, but restricts
public access to the information.