Resources for Clinical Trials in Australia

Australia’s clinical trials environment is complex, with various responsibilities resting with institutions, private organisations and companies, State or Territory Governments and the Commonwealth Government.

Below are a selection of resources that may be useful when conducting a clinical trial in Australia. 

Legislation, Regulations and Guidelines 

There are a number of Commonwealth legislation, regulations and guidelines to be considered when conducting a clinical trial in Australia. The resources listed below may be helpful in the first instance.

Note: the above list of laws and resources is indicative only.

Trial – start up

The information below may be helpful when planning a clinical trial.

Why conduct a clinical trial in Australia?

Site capability, feasibility and authorisation

Ethical considerations

Forms, fees & other resources

Trial - First participant to finish

The information below may be helpful once the clinical trial has commenced.

Trial registration

Research monitoring

The report

Closing the trial

Publishing results

Submitting a report to a marketing authorisation body

Post completion

State and Territory resources

Each State and Territory has different legislation or guidance material.  Below is an overview of some of the key information that can differ from each State and Territory.   

Australian Tele-Trial Model

The Australasian Tele-Trial Model was developed by the regional and rural group of COSA and uses tele-health to facilitate clinical trial activity. The purpose of the Model is to increase access to clinical trials for people with cancer living in rural and remote locations, although the benefits are not limited to this as it could also be utilised for patients with rare and less common cancers in metropolitan areas. COSA has led a MTPConnect funded   project to pilot the Model over the last two years and the Model has now been implemented at sites in Queensland, NSW and Victoria. There is significant interest and support for the Model from industry sponsors and investigator groups. 

COSA have developed a range of resources to support the implementation of the Tele-Trial Model for sponsors and sites. The Tele-Trials resources webpage also provides links to other resources developed in Queensland, NSW and Victoria to support the Tele-Trial Model.