AusBiotech calls for feedback on National One Stop Shop for clinical trials


AusBiotech is calling for member feedback as it develops its response to the Australian Commission on Safety and Quality in Health Care’s clinical trials ‘National One-Stop Shop’ consultation. Feedback will support the development of a single and nationally-focused health and human research approvals platform – the National One Stop Shop.

The consultation notes that a single national and interconnected approvals platform offers a significant opportunity for Australia to:

  • address long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical approval and local site authorisation systems in the jurisdictions; separate processes for Therapeutic Goods Administration (TGA) notifications; a separate process for registration on the Australian and New Zealand Clinical Trials Registry; separate processes for other jurisdiction-specific and therapy-specific approvals and authorisations and, the absence of individualised and fragmented operational monitoring and reporting approaches;
  • enhance patient access to state-of-the-art treatments;
  • improve health outcomes;
  • contribute to the innovation economy and a self-improving health system; and,
  • strengthen Australia’s global positioning in health and human research.

Options for improving research participation through a related community volunteer recruitment portal, the National Clinical Trials Front Door will also be considered through this consultation process, including mechanisms that facilitate access to third-party participant recruitment providers. 

AusBiotech has supported the concepts of a National One-Stop Shop and a National Clinical Trials Front Door since they were mooted more than two years ago, 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.

AusBiotech is dedicated to promoting Australia globally as a key destination to conduct clinical trials, and a well-designed National One-Stop Shop will be instrumental in supporting 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.

AusBiotech is working with its Clinical Trials Advisory Group to develop a response, and encourages its members to submit their feedback to Lorraine Chiroiu by Friday 10 December 2021.

Access the consultation survey here.