Progress towards a National One Stop Shop for clinical trials
In Australia, clinical trial investigators need to obtain approvals from multiple government and non-government entities before starting a trial. There is no central system to collect or share the information submitted across these entities. To address this, the Australian Government’s National One Stop Shop for clinical trials initiative will streamline and harmonise the administrative and regulatory processes for setting-up trials in Australia. The goal is to:
“…make it easier for patients, researchers, industry representatives, and sponsors to find, conduct, participate in, and invest in high-quality clinical trials research in Australia.”1
Key features of the National One Stop Shop will include:
- human research ethics approvals and site-specific authorisations,
- notifications and authorisations from the Therapeutic Goods Administration (TGA),
- real-time monitoring and reporting, and
- an enhanced version of the ANZCTR, evolving into a next-generation clinical trial registry that continues to meet World Health Organization standards.
ANZCTR’s role in the National One Stop Shop
The ANZCTR welcomes the opportunity to be part of this initiative. The ANZCTR will not stop its functions but will become a core component of the new National One Stop Shop. All current ANZCTR functions will continue, with added features to improve usability and research transparency.
Until the National One Stop Shop is launched, the ANZCTR remains committed to making improvements to its existing functions. This includes streamlining the process for updating trial information and automatically linking published protocols and results to registered trials. These improvements will help ensure better compliance with international reporting standards, including those set by the World Health Organization.
The ANZCTR is actively involved in shaping the design of the National One Stop Shop, working closely with the Australian Government through ongoing workshops and consultations.
Timeframes for the National One Stop Shop
At this stage, there is no confirmed launch date for the National One Stop Shop. Updates from the Australian Government will continue to be posted on the Australian Clinical Trials website.
Future of trial registration from countries outside of Australia
The ANZCTR currently supports trial registration in Australia, New Zealand and countries without a World Health Organization-recognised registry. The ANZCTR has advocated for continued access for international study investigators as part of the design of the National One Stop Shop. Discussions with government representatives in both Australia and New Zealand are ongoing to help ensure a coordinated approach.
1Australian Commission on Safety and Quality in Health Care. Consultation Report, Requirements for the National One Stop Shop, the National Clinical Trials Front Door and core elements of the National Site-Specific Assessment, January 2023. Available at: Consultation Report – Requirements for the National One Stop Shop.