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NHMRC

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.

All clinical trials in Australia are assessed and monitored by Human Research Ethics Committees (HRECs).

While the pharmaceutical and biotechnology industries sponsor many of the clinical trials in Australia, there are many that are initiated by researchers and health professionals. NHMRC often funds these types of trials. NHMRC, the Department of Industry, and Department of Health are working together to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

If you would like more information on clinical trials in Australia, including those currently underway, visit the Australian Clinical Trials website.

Further information on clinical trials can be found in the ‘Consumer Guide to Clinical Trials’ fact sheet (PDF, 457KB).

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 are working together and with other States and Territories to  improve the clinical trials environment in Australia and to achieve a nationally consistent approach to the way that clinical trials are conducted, to help promote education and training, and to make it easier for patients to enrol in clinical trials.

NHMRC’s progress to improve clinical trials in Australia

DATE OF LAST UPDATE:  5 January 2015
Working with states, territories and other stakeholders on a nationally consistent approach to clinical trials
Summary Activity Progress
Streamlining Research Governance - New Following extensive consultation, NHMRC has developed a ‘Good Practice Process’ for the site assessment and site authorisation phases of clinical trials research governance.

NHMRC is now seeking volunteers to act as pilot sites to test the implementability of the process. Contact riact@nhmrc.gov.au for further information.

Human Research Application Form - New NHMRC has commenced work to develop a common human research application form. NHMRC engaged Roxsolt Ltd to undertake a targeted consultation on the structure and content of a new Human Research Application Form (HRAF).

A report of the outcomes of the consultation has been published on the NHMRC website. NHMRC is now progressing development of the content and the IT solution for the form.

Streamlining Ethical Review - New In 2014-15, NHMRC will engage 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 has engaged a consultant to assess the feasibility of credentialing a small number of HRECs to consider reviews of clinical trials.
Safety reporting and monitoring NHMRC has engaged a consultant to develop a framework for safety reporting and monitoring of clinical trials. This work will be completed by March 2015.
Training and education for clinical researchers and support staff in industry and academia
Summary Activity Progress
Develop learning modules NHMRC has developed eLearning modules to provide an introductory understanding of the nature and importance of clinical trials, including ethics review and research governance. The modules will be available on www.australianclinicaltrials.gov.au in January 2015.
Support for clinical trials networks

NHMRC are providing support for clinical trials networks to improve national co-ordination and communication within and across networks. This includes:

 

 
  1. Support for the Australian Clinical Trials Alliance (ACTA) to hold an International Symposium of clinical trial networks in October 2015; and
A report will be made available on the NHMRC website.
 
  1. Through the work of ACTA, collecting information on the activity of clinical trials networks including the volume of clinical trials conducted by networks and recruitment into these trials , and on the contribution networks are making to the health system.
A report will be made available on the NHMRC website.
 
  1. Working with ACTA to develop competencies for academic clinical trialists.
NHMRC is proposing to hold a workshop to develop draft competencies in the first quarter of 2015.
Clinical Trials Portal
Summary Activity Progress
Improve functionality of clinical trials website NHMRC is improving the functionality of the Australian clinical trials website by improving the ability to search for clinical trials registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR). NHMRC has commenced work with ANZCTR to improve functionality. The enhancements are due to be completed by January 2015.
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 steering group and commenced meetings to provide advice on refinements to the website and the functionalities of the portal.
Reporting

 

Page last updated on 28 January 2015