Clinical Trials One Stop Shop report released


The long-awaited National One Stop Shop for clinical trials consultation report has been released by the Australian Commission on Safety and Quality in Health Care, revealing five key recommendations for implementing a single, national clinical trials platform.

Providing a public interface for the community and establishing enduring cross-jurisdictional governance arrangements for platform management is part of a handful of recommendations to support the implementation of Australia’s ‘National One Stop Shop’.

Twenty-three findings were identified through consultation, informing five key recommendations that, if funded and resourced, will support the Department of Health and Aged Care in implementing the National One Stop Shop and public-facing website as a nationally consistent approach to realising a harmonised operating environment for the approval and management of clinical trials and health-related research: one nation-wide, cross-government, platform.

The five key recommendations are:

  1. Implement a high-quality, fit-for-purpose National One Stop Shop and public-facing website for the community by December 2025;
  2. Enduring cross-jurisdictional governance arrangements for the management and implementation of the national platform must be established. The governing body would be responsible for the implementation and management of the platform;
  3. The platform architecture should deliver as a minimum, all requirements gathered and tested through the consultation process;
  4. The National One Stop Shop should provide a public interface so the community and their carers can easily identify trial and research options (previously referred to as the National Clinical Trials Front Door); and,
  5. The development of the platform should be accompanied by a targeted communication strategy and education campaign tailored to meet the needs of the community.

The two-part consultation was chaired by Professor Ian Chubb AC, and gathered jurisdictional and sector stakeholder preferences for the National One Stop Shop, captured a detailed understanding of the workflow systems currently in place in the sector, identified future requirements and evaluated the challenges and high-level risks involved in the development and implementation of a National One Stop Shop. The findings from the consultation also informed the Proof of Concept for the National One Stop Shop and public-facing website (the National Clinical Trials Front Door).

More than 1,400 stakeholders took part in the consultation through workshops, focus groups, meetings, webinars, surveys and written submissions, with AusBiotech acting as a conduit to Australian life science SMEs and the biotechnology industry broadly through its 3,000+ member base.

AusBiotech has supported the concepts of a National One Stop Shop and a National Clinical Trials Front Door since they were mooted, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff. Health Minister Greg Hunt has previously acknowledged these as a “golden” opportunity for Australian clinical trials.

The report noted, “For Australians to maximise the return to them of their investment in health and medical research, there is a time-critical need to coordinate the way in which research is both strategically supported and translated to care... Any substantial competition is with other countries, not between our jurisdictions.”

“A resourced and staffed office within the Australian Government Department of Health and Aged Care will be required to underpin the development and continuous maintenance and refinement of the One Stop Shop, and its evolution, so it remains fit-for-purpose.”

AusBiotech looks forward to a response from the Federal Government on this report to ensure the initiation of the report’s recommendations.

AusBiotech supports Australia’s continued global standing as a key destination to conduct clinical trials, and a well-designed National One Stop Shop will be instrumental in this mission. Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.

For more information on the National One Stop Shop consultation report, click here.