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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 July 2015
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Clinical Trials Ready initiativeUpdate 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 completed a public consultation on this initiative. NHMRC is now analysing the submissions to determine the next steps to implement this initiative.
Streamlining Research Governance - Update 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.

The Process has now been published on the NHMRC website.

NHMRC are now initiating pilots to test the implementability of the Process at 16 sites throughout Australia. The pilots will run for 6-12 months to collect data on whether the streamlined Process leads to reduced times taken for clinical trial commencement.

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

NHMRC, in conjunction with the human research ethics application (HREA) form advisory group is now developing the content for the HREA.

NHMRC has also engaged a contractor 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 conducted a targeted consultation to assess the feasibility of credentialing a small number of HRECs to consider reviews of clinical trials applications. The report from the consultation will be made 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
ACTA are finalising this event.
 
  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 contained within the report, including any information on how research has been translated into practice, will be made available on the NHMRC website.
Development of competencies for academic clinical trialists - Update

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

In August 2015, NHMRC will hold a workshop to develop draft competencies and a training pathway for academic clinical trialists.
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 Minister for Health  and Minister for Industry and Science officially launched the enhanced AustralianClinicalTrials.gov.au website. NHMRC is now raising awareness of the website to increase patient recruitment.

NHMRC is working with the Australian and New Zealand Clinical Trial Registry (ANZCTR) to improve the search functionality for trials listed on ClinicalTrials.gov.  This will be finalised by October 2015.

NHMRC has included a link to the Cancer Australia eLearning modules to provide further resources for consumers.

NHMRC has created a new Twitter account for clinical trials @AustCT.

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 advisory 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 2 July 2015