Clinical Trials

Page last updated: 05 May 2016

Clinical trials benefit patients, advance medical knowledge and are estimated to be worth around $1 billion to the Australian economy each year. The environment in which clinical trials are conducted is complex, often occurring across multiple jurisdictions and with every study needing ethics and governance approvals before it can commence.

The Australian Government is leading a body of work to improve the Australian clinical trials environment with a view to improving health outcomes and increasing international investment in Australia.

The Department of Health is working through a range of government departments, committees, and industry stakeholders to progress improvements to the clinical trial environment. Much of this work is being achieved through collaboration between Commonwealth and jurisdictional agencies, including the Clinical Trials Jurisdictional Working Group (see below) and the National Health and Medical Research Council (NHMRC).

Improvement of the clinical trials environment is occurring through strategies to:

  • enhance participation in clinical trials;
  • continue to build a best practice, quality driven clinical trials sector;
  • facilitate a predictable operating environment for clinical trials; and
  • ensure that Australia’s clinical trials capability and capacity is internationally acknowledged.

Clinical Trials Jurisdictional Working Group (CTJWG)

The Clinical Trials Jurisdictional Working Group (CTJWG) was established in July 2014 to identify and address barriers to, and enablers for, multi-jurisdictional clinical trials and improve international competitiveness for clinical trials. It involves senior officials from Commonwealth, state and territory health departments, and the National Health and Medical Research Council (NHMRC). The CTJWG works in collaboration with a range of key stakeholders, including industry, to progress its program of work.

Since its inception the CTJWG has:
  • developed a program of work to address identified barriers in the current environment;
  • consulted widely and developed a Clinical Trials Framework for Action (the Framework) to enhance collaboration and coordination of work underway to improve the clinical trials environment in Australia;
  • agreed a framework for collection of national aggregate statistics on clinical trials that will be progressively implemented by all jurisdictions and facilitate a quality improvement approach to the sector;
  • continued to work with the Department of Industry, Innovation and Science; the clinical trials sector; and the NHMRC to develop a comprehensive, national communications strategy to convey important messages about clinical trials; and
  • commenced work to investigate the issues, underlying barriers and enablers to recruitment and retention of patients to clinical trials, with a view to implementing effective change.

Industry Liaison

In 2015 the CTJWG consulted with industry stakeholders through liaison meetings held in Sydney and Melbourne to share and test CTJWG’s identified priorities and work program. The purpose was to harness the experience and perspectives of contract research organisations (CROs) and front-line industry representatives and gain a better understanding of their current priorities for the clinical trials sector.

Critical Success Factors

The Department of Health contracted Health Outcomes International (HOI) to conduct an analysis of recently conducted clinical trials in Australia to determine the critical success factors and/or reasons for failure of clinical trials in Australia. The focus of the research was on pharmaceutical and medical device trials conducted within the last five years that were commercially funded and conducted across more than one jurisdiction. The project commenced in February 2015 and was completed in June 2015.

Independent Hospital Pricing Authority’s (IHPA) determination

In 2013 the Department of Health funded the development of a table of standardised costs for conducting clinical trials in Australia. This work was first completed in 2013 by the NHMRC and the IHPA, but was subsequently revised based on stakeholder feedback.

The NHMRC prepared a revised list of clinical trial items and the IHPA released its Determination on 30 September 2015. The primary objective in developing the determination was to improve transparency of clinical trial costs and enhance efficiency of contract negotiations. Use of the Determination is not mandatory. Rather, the Determination is intended to serve as a reference point to negotiate price, and sites and sponsors can adapt the Determination based on trial-specific circumstances.

A link to the final Determination is below:
https://www.ihpa.gov.au/publications/development-table-standard-costs-conducting-clinical-trials-australia

Other useful sites

Australian clinical trials website

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