The National One Stop Shop - a national cross government platform for health-related human research

Consultation report released

The Commission convened the Health and Medical Research Advisory Group chaired by Professor Ian Chubb AC, to guide national consultations on the National One Stop Shop on behalf of the Australian Department of Health and Aged Care and all jurisdictions via the Clinical Trials Project Reference Group.

Consultations revealed broad support and a sense of genuine enthusiasm and anticipation for the proposed National One Stop Shop. It is seen as a rare transformational opportunity for Australia to address longstanding challenges.

The National One Stop Shop consultation report has been endorsed for publication by all health ministers.

The Hon Mark Butler MP, Minister for Health and Aged Care, announced the release of the consultation report for a national one-stop shop that will enable clinical trials and health and medical research to be assessed and managed in a single place.

Goal of the National One Stop Shop and National Clinical Trials Front Door

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?

• 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-related human research.

How?

Eliminate long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical 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.

Creating sustainable efficiencies within the heath related human 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
• Provide sophisticated monitoring and reporting functionality for different users.

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

Additionally, the National 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 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.

The Health and Medical Research Advisory Group chaired by Professor Ian Chubb AC, former Chief Scientist and clinical trial participant was established to guide the consultation process.

Evidence Check on national human research approvals infrastructure

The Commission undertook an update to The National Clinical Trials Governance Framework: Literature Review, with evidence for nationalised ICT infrastructure.

Evidence Check on national human research approvals infrastructure

2022

Publication, report or update

The Commission’s review of the national and international literature in 2018, revealed that governments that had invested in their local research and development environments had realised increased productivity. These countries had implemented the following:  

• A national strategic plan for change
• A national or bi-national legislation and policy framework
• A national or central coordinating agency
• A national or central ICT platform
• A national and local site capability framework
• National independent accreditation to assess local level providers.

International platforms for health and human research and clinical trials provide a harmonised, single, integrated workflow for human research ethics applications and approvals, local site risk assessment and authorisation and, submissions to the regulatory authority within a single project application profile. Other functionality includes:

• Creating, searching, viewing and amending a project
• Monitoring and communicating on the status of a project
• Storing information in a database accessible by various users, including the applicant, the Human Research Ethics Committee (HREC), HREC reviewers, sponsors, investigators and the regulator
• The provision of operational performance reporting with national benchmarks
• The capacity to generate notices and alerts, enabling users to monitor messages triggered by events that have occurred during the lifecycle of a project
• System integration with other databases to enable look-up functions by clinical condition, site, sponsor, HREC, trial and product
• Potential for automated clinical trial registration on a World Health Organization (WHO) compliant public register that provides research summaries in plain language
• User administration capability to enable users to manage the permissions of registered users that belong to their organisation or a jurisdiction
• The generation of periodic safety reporting, annual reporting and other periodic reporting and notices.

Consultations

National consultations were conducted in two phases from September 2021 to July 2022.

Forty-five written submissions were received. The National Systems Survey received 599 responses; the Community Perspectives Survey received 477 responses and the National Site-Specific Assessment Survey received 582 responses.

Consultation participants included jurisdictional health departments, health service organisations, industry, universities, medical research institutes, government agencies, Aboriginal and Torres Strait Islander groups, consumers and other individuals with an interest in the sector. 

Components of the National One Stop Shop

Consultations revealed broad support and a sense of genuine enthusiasm and anticipation for the proposed National One Stop Shop. It is seen as a rare transformational opportunity for Australia to address longstanding challenges. It would assist all governments to respond to areas of need in a rapid, coordinated and strategic manner based on real-time, accurate information.

The objective is to integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle.

It embeds new accreditation requirements for trial sites under the National Clinical Trials Governance Framework from 31 May 2023.

National consultations have sought feedback on the requirements of the proposed platform and the potential for a National One Stop Shop that at its core would:

• Provide all components of a national cross-government approvals platform within a central platform
• Provide an embedded next generation national clinical trials and research registry with automated registration to facilitate best-practice access to trials for patients and strategic capability for governments and stakeholders.
• Incorporate national clinical trials / research systems such as the clinical trial notification (CTN) and clinical trials approvals (CTA) schemes, relevant aspects of other systems such as the Good Clinical Practice Site Inspection Program and processes of the Gene Technology Regulator
• Embed the National Clinical Trials Governance Framework accreditation obligations and automated data, reports and processes to support the accreditation process
• Provide relevant research management, monitoring and compliance reporting functionality for different users, including safety and adverse event reporting, and annual human research ethics committee reporting, with dashboards for different users. 

Following implementation, this platform would replace other national and jurisdictional systems. To achieve the desired reform outcomes, cross-jurisdictional governance arrangements with representation from all jurisdictional health departments, or their equivalent, and the TGA, the OGTR, the NHMRC and the Commission, will be needed to harmonise the approvals processes nationally. Such governance arrangements were strongly supported by key stakeholders during the consultations. Many stakeholders expressed the view that an innovative and intuitive approvals platform combining the functionality and with jurisdictional governance arrangements would make the research process significantly easier and less burdensome in Australia.

National SSA minimum requirements consultations

As part of the second phase of consultations, the Commission conducted consultations on the core elements of the national SSA. The aim of the single national SSA is to ensure a single process for local site risk assessment and authorisation for health-related human research. The goals of the national SSA are to: 

• Minimise duplication and the administrative burden related to local site research authorisation
• Include above the line (national) requirements
• Include below the line (jurisdictional) requirements (these requirements do not include the consideration of jurisdictional legislation that would be undertaken at the time of ethical review)
• Enable direct sign-off to authorising officers.

An SSA Expert Reference Group was established to guide the consultations on the national SSA core elements with members nominated by the CTPRG. The Commission conducted four targeted consultations and two public webinars to ensure engagement with the broader sector in March 2022.

A national SSA survey was developed to collect feedback on the existing draft National SSA from the research community. The survey was published on the Commission’s website for two weeks on Monday 28 February 2022 and received 582 responses. In total, more than 842 individuals and groups participated in the national SSA consultations.

The CTPRG endorsed in principle the single national SSA core elements with agreed amendments for implementation via the National One Stop Shop subject to feedback through the second phase of national consultations. The SSA consultations are now closed. 

National Clinical Trials Front Door

A range of views and options were explored throughout the consultations. There is broad support for a public facing website that acts as a central access point to facilitate connectivity for health researchers, sponsors, industry, primary carers, allied health and the community.

If you have any questions, please contact HMR@safetyandquality.gov.au.