For many people living with a rare disease, participation in clinical trials is the only way to access treatment. The National Strategic Action Plan for Rare Diseases (the Action Plan) outlines the importance of streamlining processes in Australia to reduce the barriers to clinical trials for rare disease; the National One Stop Shop and National Clinical Trials Front Door (the One Stop Shop) is one mechanism towards this.
The Australian Commission on Safety and Quality in Health Care (the Commission) was engaged by the Australian Government Department of Health, in partnership with all jurisdictions via the Clinical Trials Reference Group, to consult with all stakeholders and to develop the One Stop Shop framework and web platform.
The goal of the One Stop Shop is to simplify the processes for patients, researchers, industry and sponsors to find, conduct, participate and invest in high-quality, ethical research in Australia. The One Stop Shop aims to:
- Enhance access to state-of-the-art treatments
- Improve health outcomes
- Contribute to innovation economy and a self-improving health system
- Strengthen Australia’s global positioning in health-related human research
The One Stop Shop’s proof-of-concept web platform brings together the business processes, authorisation and notification systems of the Therapeutic Goods Administration, the Gene Technology Regulator and locally developed clinical trial management systems. It also aims to promote the need for single national ethics and site-specific approval (SSA) processes in one centralised platform made transparent for, and tailored to, all stakeholders.
Since late 2021, Rare Voices Australia (RVA) has attended several public and private consultations to contribute rare disease perspectives at different phases of the One Stop Shop project. RVA also prepared two written submissions. Leveraging key priorities and actions in the Action Plan, the first submission provided rare disease perspectives to the development of the National Clinical Trials Governance Framework (Governance Framework). Also leveraging the Action Plan, RVA’s second submission addressed the proposed national SSA minimum core elements and proof-of-concept web platform, which was developed in consultation with subject matter experts across all jurisdictions in Australia. To review RVA’s submissions please follow these links:
- RVA Submission to the National One Stop Shop and the National Clinical Trials Front Door Proposal
- RVA Submission to the National One Stop Shop and the National Clinical Trials Front Door Proposal National SSA Minimum Core Elements
On 24 May 2022 the Secretary of the Australian Government Department of Health launched the Governance Framework. You can watch the launch at this link. Assessment of the Governance Framework is scheduled to commence in January 2023 under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. The Commission is still working on supporting resources in preparation for the assessment.
The Commission will submit a full report and the proof-of-concept web platform to the Australian Government for their consideration for future implementation. To progress key priorities in the Action Plan and improve the lives of people living with a rare disease, RVA recommends timely review of the Commission’s report and proof-of-concept for the One Stop Shop, together with a national plan for its sustainable implementation.
To learn more about the One Stop Shop or keep track of progress, please visit the Commission’s website.
