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.

Note

NHMRC does not manage or oversee individual clinical trials.

Between 2013 and 2017 we undertook a series of projects to position Australia as a world leader in clinical research. Through this work we supported a nationally consistent approach to clinical trials. A number of resources from this work can be found at the bottom of this page.

In particular, we helped achieve:

Timely and more efficient research governance

• Developing and piloting the Good Practice Process for Site Assessment and Authorisation of Clinical Trials which can reduce the start of time of clinical trials by approximately 100 days. The Good practice Process was piloted in 16 sites in 2015 and 2016 and NHMRC has published a report from the pilots.
• Developing a revised list of standard items associated with clinical trials which have been costed by the Independent Hospital Pricing Authority
• Raising awareness of the laws and regulations that apply to ethical review and research governance, in particular those that relate to consent and guardianship requirements. (see Downloads for resources for researchers and HRECs).
• Raising awareness of the indemnity and insurance arrangements for clinical trials in Australia.

Efficient ethics approval

• Developing the Human Research Ethics Application (HREA), a streamlined and contemporary national application form for research involving humans.
• Reviewing the NHMRC National Certification Scheme of Institutional Processes related to the Ethical Review of Multi-Centre Research  to determine options for improving the operation of the scheme.
• Establishing 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.

The National Scientific Committees were administered by Bellberry Limited, a private not-for-profit organisation providing scientific and ethical review of human research projects across Australia. The National Scientific Committees pilot commenced in January 2017 and ended in June 2018.

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

The report includes the Terms of reference, Standard Operating Procedures and Members Review Checklist, developed for the pilot. 

The pilot found that the use of a panel of experts to provide a scientific opinion on research proposals was considered valuable by researchers, sponsors and HRECs. Likewise, establishing a pool of suitable experts was seen to help maximise the availability of expertise to Australia's ethics review bodies, which may otherwise struggle to identify suitable individuals to assist with the scientific review of certain studies.

The pilot found that demand was greatest for early phase clinical trial proposals, with trials involving medical devices benefiting to a lesser extent from the National Scientific Committees. There was little demand for reviews of complex genetic research proposals.

Given that demand was concentrated on early phase clinical trials, and as a number of jurisdictions and groups have since developed their own initiatives to improve the scientific review of early phase clinical trials (including through the better identification of individuals and bodies with appropriate expertise), NHMRC is not proposing to continue with the National Scientific Committees. Information on the NSW early phase clinical trials initiative can be found here.

Increasing readiness and transparency

• Promoting consistency in safety monitoring and reporting of clinical trials by developing, in conjunction with the Therapeutic Goods Administration (TGA), guidance for Safety Monitoring and Reporting in Clinical Trials to align arrangements in Australia with international practices.
• Reporting of Clinical Trial results by providing 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.

Better trained staff

• Developing three eLearning Modules to provide an introductory understanding of the nature and importance of clinical trials, their ethics review and governance.
• Supporting development of a V.E.T accredited course in conjunction with the Department of Industry, Innovation and Science for clinical trials proponents.
• Developing, in conjunction with the Australian Clinical Trials Alliance (ACTA), Core Competencies for Australian Academic Clinical Trialists.

Increasing recruitment and awareness

• Enhancing the Australian Clinical Trials' website (which launched in 2012) to provide information and resources to consumers, researchers and clinicians about Australian Government Clinical Trials initiatives.
• Highlighting Australia's capacity and international competitiveness as a destination to conduct clinical trials.

Useful resources

• Good Practice Process for Site Assessment and Authorisation of Clinical Trials
• Competencies for Australian Academic Clinical Trialists
• Guidance of Safety Monitoring and Reporting in Clinical Trials
• Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia.

Enquiries

Note

NHMRC does not manage or oversee individual clinical trials. For information on clinical trials see Australian Clinical Trials