National One-Stop-Shop

Topics:Advocacy

National platform for health and medical research

The Australian Commission on Safety and Quality in Health Care (Commission) is conducting national consultations to scope the requirements for a national health and medical research platform – a National One-Stop-Shop.

This proposed national online portal for all health and medical research will make it easier for researchers, industry representatives and sponsors to find, conduct, participate and invest in research in Australia.

The concept for the National One-Stop-Shop was developed by the Clinical Trials Project Reference Group and presents a significant opportunity to achieve a national, interconnected, rapid and streamlined approvals platform that will:

  • include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification and approval systems
  • incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration (TGA)
  • include an embedded and automated next-generation national clinical trials registry
  • provide sophisticated monitoring and reporting functionality for different users.

Options for improving patient recruitment through a related National Clinical Trials Front Door, will also be considered.

Integrating with existing systems, the National One-Stop-Shop will reduce administration, and support every stage of research, from application to approval and reporting.

A project advisory group, chaired by Professor Ian Chubb, former Chief Scientist and clinical trial participant, will be established to guide the consultation process.

ACTA welcomes consultations on the National One-Stop-Shop for health and medical research

ACTA understands that the overall goal of the One-Stop-Shop is a single national, interconnected, rapid and streamlined approvals platform. ACTA strongly supports initiatives to reduce duplication and unnecessary workload when seeking ethical and governance approval for clinical trials.

Through the consultation, we will be advocating that the system:

  • Is suitable for the full range of trial designs, including non-pharmacological interventions, pilot trials and cluster designs.
  • Will be as suitable for the investigator-led sector as it is for pharma sponsored trials.
  • Provides harmonisation pathways to avoid, and where necessary, reconcile differences in the interpretation of requirements by different area health services.
  • Can be accessed by or interacts effectively with trials that are not conducted in the public healthcare system, such as community-based trials and trials that are recruiting in the private healthcare sector.
  • Explores continuity and preferably integration with an upgraded trial registry in Australia, building on the current ANZCTR.
  • Is appropriately pilot tested, with feedback and transitionary arrangements.
  • Includes a commitment to provide regular updates to the sector.

ACTA recognises the diversity of experts within our sector, from clinician researchers across the full range of clinical disciplines, specialist research staff, consumers, statisticians, implementation scientists, and health economists, all of whom want an approval system that minimises unnecessary duplication and workload as well as being speedy and predictable. ACTA will aim to provide a coordinated response that represents all of the investigator-initiated trial sector, capturing your voice.

We will continue to seek additional information on the consultations, which is anticipated to commence in July, and provide regular updates to the sector. We invite you to share your thoughts at any time, either in a return email or by requesting a meeting through the ACTA Team.

Register your interest in the consultations

Consultations start in July to gather the requirements for the National One-Stop-Shop and the National Clinical Trials Front Door.

Targeted consultations with state and territory health departments and health and medical research organisations will be followed by broad consultation across the sector with clinicians, consumers, healthcare providers and professional bodies.

Click on the 'Register your interest' button below and complete the required information to receive updates on how to be involved.

For any queries, please contact: