National One Stop Shop and National Clinical Trials Front Door
One Stop Shop update – May 2024
The National One Stop Shop for clinical trials and health research project has received $18.8m in the 2024 budget to progress this project.
A National One Stop Shop will harmonise and nationalise the administration and regulation of health and medical research, including through establishing an easy-to-use website which will help patients, researchers and industry find, conduct and participate in clinical trials and research.
Emeritus Professor Ian Chubb AC will continue to lead key reforms to progress the business case for the National One Stop Shop, in his role as the Chair of the Inter-Governmental Policy Reform Group (IGPRG).
Background
The Australian Commission on Safety and Quality in Health Care has been engaged by the Australian Government Department of Health, in partnership with all jurisdictions (including SA Health) via the Inter-Governmental Policy Reform Group (IGPRG), to conduct consultations to develop the requirements and specifications of the National One Stop Shop for health-related human research approvals and the National Clinical Trials Front Door.
Goal
To make it easier for patients, researchers, industry representatives and sponsors to find, conduct, participate and invest in high quality and ethical research in Australia.
Why
- 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 (ANZCTR); 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
- Strengthen Australia’s global positioning in health and medical research.
How
Creating sustainable efficiencies within the clinical trials and research sector through a single national, interconnected, rapid and streamlined world-leading approvals platform in collaboration with all jurisdictions that will:
- Provide a cross-jurisdictional ethics approval and site-specific authorisation platform that incorporates key application, notification and approval systems
- Incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the TGA
- Include an embedded and automated next-generation national clinical trials registry that will supersede the ANZCTR
- Provide sophisticated monitoring and reporting functionality for different users.
Options for improving research participation through a related community volunteer portal, the National Clinical Trials Front Door initiative will also be considered through the consultation process. This includes mechanisms that facilitate access to third party participant recruitment providers.
Additionally, the One Stop Shop will:
- Embed the National Clinical Trials Governance Framework accreditation obligations and automate data/reports/processes to support the accreditation process
- Assist all governments to respond to areas of need in a rapid, coordinated and strategic manner based on real-time, accurate information regarding clinical trial activity and site capability
- Aim to extend beyond the public and private hospital sector to incorporate the university, primary care and independent medical research sectors
- Protect data integrity and adhere to data security requirements.
Find out more on the Commission’s web page, or contact the Health and Medical Research team at HMR@safetyandquality.gov.au.