Clinical trial reform

Clinical trials are essential for evaluating the effectiveness and safety of medicines, devices, services and interventions to help prevent, detect or treat illness and disease. It is through the research done in clinical trials that people gain access to better treatments. Clinical trials also bring hundreds of millions of dollars each year into the Australian economy and support a highly skilled workforce.

If you would like more information on clinical trials in Australia, please visit Australian Clinical Trials. Please note that NHMRC does not manage or oversee individual clinical trials.

If you would like information on jurisdictional legislation, law, regulation, policy or directives relating to research involving children or incapacitated adults or other matters that are subject to legislation, please contact the relevant jurisdiction. For appropriate contact information, we recommend a search of the jurisdictional health department’s website with search terms such as ‘research’, ‘research governance’, ‘research ethics’ and/or ‘clinical trials’.

Between 2013 and 2017 we undertook work to support a nationally consistent approach to clinical trials. A number of resources from this work can be found at the bottom of this page.

NHMRC Initiatives 2013 to 2017

To facilitate efficient ethics approval, we developed the Human Research Ethics Application (HREA), a streamlined and contemporary national application form for research involving humans.

We reviewed the NHMRC National Certification Scheme of Institutional Processes related to the Ethical Review of Multi-Centre Researchto determine options for improving the operation of the scheme.

We established a pilot of 3 National Scientific Committees to provide advice to HRECs on the scientific merit and integrity of research proposals that involve:

• complex genetic research
• clinical trials involving medical devices, or
• early phase clinical trials.

A report from the pilot is available (see 'Download' section, below).

To promote consistency in safety monitoring and reporting of clinical trials we partnered with the Therapeutic Goods Administration (TGA) to develop guidance for Safety Monitoring and Reporting in Clinical Trials in order to align arrangements in Australia with international practices.

We issued a statement in support of the principles behind the Alltrials campaign which calls for all clinical trials to be registered and their results reported, to reduce research duplication and legitimise trial results.

Useful resources

• Guidance on Safety Monitoring and Reporting in Clinical Trials
• Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia.