Clinical Trials Jurisdictional Working Group

The role of the Clinical Trials Project Reference Group (CTPRG) is to identify and implement actions and system redesign that will enable a streamlined and consistent national approach to clinical trials within Australia, with the intention of enhancing health outcomes and building Australia’s ability to attract national and international clinical trials. The Reference Group will take a strategic focus, and engage with clinical trials industry and networked partners and other key stakeholders, including consumers and registry groups, to progress clinical trials redesign, ensure effective coordination and implementation of activity, minimise potential duplication of effort, and collaborate on awareness raising activities. The scope of activities defined in the ToR included a number of areas, including: 1. Consider the broad range of issues relevant to enhancing clinical trials and related research and regulatory processes. 2. Identify and address barriers, including regulatory barriers, to a streamlined and consistent national approach to clinical trials that state and territory governments can address. 3. Identify and address specific and achievable actions to enable the conduct of efficient, safe and quality clinical trials. 4. Facilitate jurisdictional clinical trials systems redesign in line with CHC-endorsed Principles and Priority Action Areas and the Commonwealth’s Encouraging More Clinical Trials Budget measure to better organise sites and streamline clinical trials processes. This will also include jurisdictional collaboration to ensure adequate evaluation of the measure. 5. Develop a National Clinical Trials Governance Framework with a view to the incorporation of a future clinical trials governance standard into National Safety and Quality Standards. 6. Implement activities agreed under an AHMAC and CHC-endorsed CTPRG revised Implementation Plan with particular focus on key areas including: • expanding and embedding clinical trials metrics system and collection and reporting of data agreed under the Framework for National Aggregate Statistics; • further enhancing national consistency for clinical trials ethics and governance; • improving efficiency of recruitment and retention; and • promoting Australia’s position as a preferred location for performing clinical trials including through implementation of a broad communications approach to engage stakeholders. 7. Facilitate key partnerships across the broad range of stakeholders, including through a Clinical Trials Collaborative Group to involve key industry and sector stakeholders, to contribute to enhancing Australia’s clinical trials environment.