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NHMRC

Clinical Trials

Clinical trials are essential for evaluating the effectiveness and safety of drugs, 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 sooner. Clinical trials also bring hundreds of millions of dollars each year into the Australian economy.

All clinical trials in Australia are assessed and monitored by Human Research Ethics Committees (HRECs).

While the pharmaceutical and biotechnology industries sponsor many of the clinical trials in Australia, there are many that are initiated by researchers and health professionals. NHMRC often funds these types of trials. NHMRC, the Department of Industry, and Department of Health are working together to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

If you would like more information on clinical trials in Australia, including those currently underway, visit the Australian Clinical Trials website.

Further information on clinical trials can be found in the ‘Consumer Guide to Clinical Trials’ fact sheet (PDF, 457KB).

The Australian Clinical Trials Environment

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.

Australian Government Clinical Trials Initiatives

NHMRC, the Department of Health and the Department of Industry are working together and with other States and Territories to  improve the clinical trials environment in Australia and to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

NHMRC’s progress to improve clinical trials in Australia

Completed NHMRC activities

Current activities

DATE OF LAST UPDATE:  1 May 2015
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Clinical Trials Ready initiative - New NHMRC has developed an initiative to recognise clinical trial sites, including public and private hospitals and other organisations that are ‘ready, willing and able’ to carry out high quality clinical trials in a timely, transparent and efficient manner.  NHMRC has now released a public consultation on this initative. This is available at http://consultations.nhmrc.gov.au/public_consultations/clinical-trials
Streamlining Research Governance Following extensive consultation, NHMRC has developed a ‘Good Practice Process’ (The Process) for the site assessment and site authorisation phases of clinical trials research governance.

NHMRC is working with the Research Governance working group to finalise the Process.

Over 20 sites have expressed interest in being pilot sites to test the Process.

Human Research Application Form NHMRC is developing a common human research application form.

NHMRC is now progressing development of the content in consultation with the HRAF advisory group.

NHMRC has issued a request for tender to develop a proof of concept and subsequent build for the IT solution for the form.

Streamlining Ethical Review In 2014-15, NHMRC will engage consultants to advise on the feasibility of, and the framework, criteria and process for, credentialing a small number of national ‘clinical trial’ Human Research Ethics Committees (HRECs). NHMRC engaged a consultant to conduct a targeted consultation to assess the feasibility of credentialing a small number of HRECs to consider reviews of clinical trials applications. The consultation has now closed. NHMRC will consider the outcomes of the consultation.
Safety monitoring and reporting NHMRC has engaged a consultant to assess the need to amend the framework for safety monitoring and reporting of clinical trials. This consultation has now closed. A final report has now been provided to NHMRC which will be available on the NHMRC website.
Training and education for clinical researchers and support staff in industry and academia
Summary Activity Progress
Support for clinical trials networks

NHMRC are conducting a number of activities to support clinical trials networks to improve national co-ordination and communication within and across networks. These include:

 

 
  1. Providing support for the Australian Clinical Trials Alliance (ACTA) to hold an International Symposium of clinical trial networks in October 2015; and
 
 
  1. 2. Through the work of ACTA, collecting information on the activity of clinical trials networks including the number of clinical trials conducted by networks, recruitment into these trials, and the contribution that networks are making to the health system.
A report of this activity  will be provided to NHMRC by the end of June 2015. Information will be made available on the NHMRC website.
Development of competencies for academic clinical trialists

NHMRC will work with ACTA to develop competencies for academic clinical trialists.

With the assistance of ACTA, NHMRC will hold a workshop to develop draft competencies. This will be held in mid 2015.
Clinical Trials Portal
Summary Activity Progress
Improve functionality of clinical trials website - Update NHMRC is working through ways to further enhance the usability of the website. The website is now optimised for viewing on mobile devices. NHMRC is now raising awareness of the website to increase patient recruitment.
Development of national interactive portal The Department of Industry and Science, assisted by NHMRC, is working to expand the functionality of the website to ultimately develop an interactive portal to streamline the administrative process and further boost participant recruitment. NHMRC has established a portal steering group and organises meetings to provide advice on refinements to the website and the functionalities of the portal.
Engagement with Stakeholders

Reporting

 

Page last updated on 5 May 2015