NHMRC update on progress of Australian Government initiatives to improve clinical trails in Australia

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 (link is external).

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 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
  • Establishing 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 April  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.

NHMRC has completed a public consultation.

The report from this public consultation 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 held a meeting of pilot sites and with some sponsor/ CRO representatives on 30 November 2015.

Outcomes of this meeting are available on the website.

NHMRC is reviewing the final reports from pilot sites and considering further testing of the Good Practice Process.

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 finalised the content following input from key stakeholders including ethics committees, jurisdictional and institutional representatives.

NHMRC has commenced testing of the application with sites in the ACT. NHMRC will be conducting broad user testing on the usability of the form and the IT solution prior to the beta release.

Safety Monitoring and reporting  - Update NHMRC is updating 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.

The draft Position Statement will be made available for public comment shortly.

Streamlining Ethics Review  -Update

NHMRC conducted a targeted consultation to assess the feasibility of credentialing a small number of HRECs to consider reviews of clinical trials applications.

NHMRC is establishing independent, national scientific committees to provide advice to researchers and HRECs on medical device trials and complex genetic research.

NHMRC will shortly commence a review of the National Certification Scheme for institutional ethical review processes of multi-centre human research (the National Certification Scheme)

The report from the consultation is available on the NHMRC website.

NHMRC sought expressions of interest (EOI) for the establishment of and provision of secretariat services for national review committees for medical devices and genetics. NHMRC is now evaluating the submissions.

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
The International Symposium was held in Sydney from 7 – 10 October 2015. Speaker presentations have now published on the ACTA website.
  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 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. NHMRC is finalising the draft competencies.
Clinical Trials Portal
Summary Activity Progress
Improve functionality of clinical trials website  - Update 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.

NHMRC has engaged a production company to film a selection of  participant and researcher 'real stories.'

NHMRC has engaged a firm to determine the feasibility of developing a mobile App.

Development of national interactive portal The Department of Industry, Innovation  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 continues to work with the Department of Industry to develop a subscription notification service.
Engagement with Stakeholders