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 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 of a human research ethics application (HREA)
- Promoting consistency in safety monitoring and reporting arrangements
- Looking at options of how to improve single ethical review by HRECs
- Analysing responses to a consultation on the Clinical Trials Ready initiative 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 October 2015|
|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.||NHMRC has completed a public consultation on this initiative and is now analysing the submissions to determine the next steps to implement this initiative.|
|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.||
The Good Practice Process has now been published on the NHMRC website.
Pilots have now commenced 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 Process leads to reduced times taken for clinical trial commencement.
NHMRC will be working with sponsors/ CROs and sites to determine mechanisms to further streamline the process.
|Human Research Application Form - Update||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 developed a proof of concept for the IT solution for the form.
NHMRC has held meetings with key Information Management vendors to determine the necessary interoperability of the HREA with existing institutional systems.
NHMRC will be seeking input from key stakeholders including ethics committees, jurisdictional and institutional representatives on the content of the form and on the usability of the IT solution.
NHMRC has published Frequently Asked Questions (FAQ) on the NHMRC website
|Streamlining Ethics Review - Update||NHMRC engaged 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 has now been published on the NHMRC website. NHMRC is currently reviewing the findings of the report to determine the next steps for this initiative.|
|Training and education for clinical researchers and support staff in industry and academia|
|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:
||Registrations are now open for the Symposium|
||A report of this activity will be provided to NHMRC. 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 held a workshop to commence the development of a set of draft competencies and a training framework for academic clinical trialists. Details of the roundtable are now on the NHMRC website. NHMRC is now finalising the draft competencies.|
|Clinical Trials Portal|
|Improve functionality of clinical trials website - Update||NHMRC is working through ways to further enhance the usability of the AustralianClinicalTrials.gov.au website.||
NHMRC is now raising awareness of the website to increase patient recruitment.
NHMRC has been working with the Australian and New Zealand Clinical Trial Registry (ANZCTR) to improve the search functionality for trials listed on ClinicalTrials.gov that have a least one site in Australia. This is now complete.
NHMRC has included details of the Austrade Clinical Trials Industry Capability Report to provide further resources for Industry and sponsors.
NHMRC is currently conducting a survey of General Practitioners on participation in Clinical Trials.
NHMRC has created a new Twitter account for clinical trials @AustCT.
NHMRC have published a revised Consumer Guide to Clinical Trials fact sheet.
|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 the functionalities of the portal.|
|Engagement with Stakeholders|