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.
If you would like more information on clinical trials in Australia, including those currently underway, visit the Australian Clinical Trials website.
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, Innovation and Science are working with States and Territories and other key stakeholders to improve the clinical trials environment in Australia.
- A combined update on all clinical trials initiatives is available on the Australian Clinical Trials website.
NHMRC’s progress to improve clinical trials in Australia
NHMRC is working with States, Territories, clinical trials sites, sponsors and researchers to achieve:
- Timely and more efficient research governance authorisation
- Efficient Ethics Approval
- Increased Site Readiness and Transparency
- Better Trained Staff
- Increased Recruitment and Awareness
These initiatives will ultimately lead to Australia becoming more competitive globally and continuing to deliver clinical trials of high quality.
Key ongoing Activities:
- Pilot studies to test a Good Practice Process for site assessment and authorisation of clinical trial research governance
- Development and testing of a human research ethics application (HREA)
- Promoting consistency in safety monitoring and reporting arrangements for clinical trials
- Looking at options of how to improve single ethical review by HRECs
- Working with a representative committee to assist with the development of key criteria and assessment process for the Clinical Trials Ready initiative, which seeks to promote sites that are ready, willing and able to conduct clinical trials
- Raising awareness of the Australian Clinical Trials website to increase patient recruitment
Further information on NHMRC activities
|DATE OF LAST UPDATE: 1 July 2016|
|Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials|
|Clinical Trials Ready initiative||
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.
The report from a public consultation on Clinical Trials Ready has now been published on the NHMRC website.
NHMRC is now establishing an advisory group to finalise the criteria and mechanism by which sites will be recognised.
|Streamlining Research Governance||
Following extensive consultation, NHMRC has developed a ‘Good Practice Process’ for the site assessment and site authorisation phases of clinical trials research governance and has commenced pilots studies to test the implementability of the Process at 16 sites throughout Australia.
The Good Practice Process is available on the NHMRC website.
NHMRC is analysing the information obtained from pilot sites and is considering further testing of the Good Practice Process.
|Human Research Ethics Application - Update||
NHMRC in conjunction with a Human Research Ethics Application (HREA) advisory group is developing a common human research ethics application (HREA).
NHMRC has commenced beta testing of the application with 28 sites. Beta testing of the usability of the form and the IT solution will occur until end of August prior to general release later in the year.
|Safety Monitoring and reporting - Update||
NHMRC is updating the AHEC Monitoring and reporting of safety for clinical trials involving therapeutic products (Position Statement).
NHMRC held two meetings of a working committee to revise the NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials.
Following a public consultation, NHMRC has now finalised the draft revised Position Statement. This will now go to AHEC for their agreement to issue.
|Streamlining Ethics Review||
NHMRC is establishing independent, national scientific committees to provide advice to researchers and HRECs on medical device trials and complex genetic research.
NHMRC is conducting a review of the National Certification Scheme for institutional ethical review processes of multi-centre human research (the National Certification Scheme)
Through engagement of a consultation, NHMRC will develop a tool for HRECs to identify relevant laws that relate to consent a guardianship requirements.
NHMRC has engaged Bellberry to host two independent national scientific committees with expertise in: complex genetic research; and clinical trials involving medical devices.
NHMRC has engaged a consultant to conduct a review of the National Certification Scheme.
NHMRC has now finalised a draft report on relevant State, Territory and National laws. This will be provided to State and Territory health departments for their consideration prior to publishing.
|Training and education for clinical researchers and support staff in industry and academia|
|Support for clinical trials networks||
NHMRC have conducted a number of activities to support clinical trials networks to improve national co-ordination and communication within and across networks. These include:
||The International Symposium was held in Sydney from 7 – 10 October 2015.|
||The report from this workhas now been published and is available on the NHMRC website.|
|Development of competencies for academic clinical trialists||
NHMRC is working with ACTA to develop competencies for academic clinical trialists. In August 2015, NHMRC held a workshop to commence the development of a set of draft competencies and a training framework for academic clinical trialists.
|NHMRC is finalising the draft competencies.|
|Clinical Trials Portal|
|Improve functionality of clinical trials website||NHMRC is working with a portal advisory group to explore ways to further enhance the usability and search functionality of the AustralianClinicalTrials.gov.au website and to raise awareness of the website to increase patient recruitment. This includes the addition of stories from participants and researchers, and determining the need for a mobile Application to support the website.||
Ten participant and researcher 'real stories have been published as videos on AustralianClinicalTrials.gov.auNHMRC has engaged a consultant to determine the feasibility of developing a mobile App.
|Development of national interactive portal||The Department of Industry, Innovation and Science (DoIIS), with input from 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.||
DoIIS and NHMRC have enhanced the website to enable users to subscribe and receive alerts when new trials are registered.
|Engagement with Stakeholders|