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:
- Working with clinical trial sponsors and sites to continue to improve the timeliness of the clinical trial start-up process.
- 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 an advisory committee to develop the Clinical Trials Ready initiative, which seeks to identify and recognise sites that are ready, willing and able to conduct clinical trials in a safe, quality, efficient and transparent manner
- Raising awareness of the Australian Clinical Trials website to increase patient recruitment
Further information on NHMRC activities
|DATE OF LAST UPDATE: 1 June 2017|
|Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials|
|Streamlining Research Governance||
NHMRC has developed a ‘Good Practice Process’ for the site assessment and site authorisation phases of clinical trials research governance. Following piloting of the Process at 16 sites throughout Australia, on average, more than 100 days was able to be removed from the time taken for clinical trial commencement.
The Good Practice Process and the report from the Pilots is now available on the NHMRC website. NHMRC is working with 9 sites on Phase 2 of the Good Practice Process. A webinar on the Process was held in conjuction with ARCS on 14 February. The Phase 2 draft final reports have been submitted and are currently being reviewed.
|Human Research Ethics Application – Update||
NHMRC in conjunction with a Human Research Ethics Application (HREA) advisory group has developed a common human research ethics application (HREA). The HREA is a streamlined and contemporary ethics application that uses dynamic content and guidance to assist researchers to consider and address the principles of the National Statement on Ethical Conduct in Human Research, 2007.
HREA was released on 14 December 2016. There are currently 4713 registered users. Further information can be found on the NHMRC website.
|Safety Monitoring and reporting||
NHMRC has published updated guidance on Safety Monitoring and Reporting in Clinical Trials on the NHMRC website. This has been endorsed by the Therapeutic Goods Administration.
Supplementary guidance on Risk-adapted Clinical Trials, use of Data Safety Monitoring Boards/Committees and handling Serious Protocol Breaches was released for a targeted consultation in March 2017.
NHMRC is now finalising the supplementary guidance. Subject to endorsement by the Therapeutic Goods Administration and the Australian Health Ethics Committee, the supplementary guidance will be published in August 2017.
|Streamlining Ethics Review – Update||
1. NHMRC has established 2 independent, national scientific committees to provide advice to researchers and HRECs on medical device trials and complex genetic research and has engaged Bellberry Limited to provide secretariat services to the scientific committees.
2. NHMRC has conducted a review of the National Certification Scheme for institutional ethical review processes of multi-centre human research (the National Certification Scheme)
3. Through engagement of a consultant, NHMRC will develop a tool for HRECs to identify relevant laws that relate to consent a guardianship requirements.
1. These committees were launched in January 2017. Further information can be found at http://www.nationalscientificcommittees.org.au/
2. NHMRC is reviewing the findings from the review and preparing a response. The report and response will be published on the NHMRC website by June 2017.
3. NHMRC has now finalised a draft report on relevant State, Territory and National laws and a series of Fact Sheets on jurisdictional consent and guardianship laws. These are now published on the NHMRC website.
|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 work has now been published and is available on the NHMRC website.|
|Development of competencies for academic clinical trialists||
NHMRC held a workshop to commence the development of a set of draft competencies for academic clinical trialists.
|Following agreement from a number of NHMRC’s principal committees, NHMRC will conduct a targeted consultation to determine their acceptability and usability as part of an education framework.|
|Clinical Trials Portal|
|Improve functionality of clinical trials website – Update||
NHMRC is continuing to add stories from participants and researchers on their clinical trial experiences.
Further 'real stories’ from health care providers have been published as videos on AustralianClinicalTrials.gov.au
|Development of national interactive portal – Update||The Department of Industry, Innovation and Science (DoIIS), and NHMRC, are 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 further enhanced the website. Additional functionality now includes:
|Engagement with Stakeholders|
NHMRC provides updates to the Clinical Trials Advisory Committee (CTAC)(link is external) on the progress of work under the initiative.
NHMRC provides updates to the States and Territories through a variety of forums, including:
Through the Commonwealth, to:
In addition, regular coordination meetings occur with the Department of Industry and Science and Department on Health on progress delivering clinical trials reform.