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.

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.

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

Current activities

DATE OF LAST UPDATE: 1 August 2016
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
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  - Update

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 has analysed the information obtained from pilot sites and will be releasing a report shortly.

Human Research Ethics Application 

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 is in progress and will continue until the end of August.  General release of the HREA will occur later in the year.

Safety Monitoring and reporting  

NHMRC is revising 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.

NHMRC has now finalised the draft revised Position Statement. This will now go to AHEC for their agreement to release, pending support from the TGA. 

Streamlining Ethics Review  - Update

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 consultant, NHMRC will develop a tool for HRECs to identify relevant laws that relate to consent a guardianship requirements.

NHMRC has engaged Bellberry to provide secretariat services for two independent national scientific committees with expertise in: complex genetic research; and clinical trials involving medical devices. 

NHMRC is conducting a consultation  to determine ways in which the  National Certification Scheme can continue to meet community needs and expectations.

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
Summary Activity Progress
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:

 
 
  1. Providing support for the Australian Clinical Trials Alliance (ACTA) to hold an International Symposium of clinical trial networks in October 2015; and
The International Symposium was held in Sydney from 7 – 10 October 2015. 
 
  1. 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.
The report from this workhas 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.

NHMRC is finalising the draft competencies.
Clinical Trials Portal 
Summary Activity Progress
Improve functionality of clinical trials website  - Update NHMRC is currently adding stories from participants and researchers on their clinical trial experiences, 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.au 

NHMRC is now conducting a consultation on the feasibility of an 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

Reporting

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:

  • State and Territory Health Ministers through the COAG Standing Council on Health (SCoH)(link is external) and the Australian Health Ministers’ Advisory Committee (AHMAC)(link is external);
  • Directors-General of Health through, the Hospitals Principal Committee(link is external) (HPC) and
  • The Clinical Trials Jurisdictional Working Group of the HPC.

In addition, regular coordination meetings occur with the Department of Industry and Science and Department on Health on progress delivering clinical trials reform.

Open Consultations

Closes 11.59pm 19 August

Closes 5pm 31 August