Clinical Trials Project Reference Group (CTPRG)
The Clinical Trials Project Reference Group (CTPRG), formerly the Clinical Trials Jurisdictional Working Group (CTJWG), was established in July 2014 and involves senior officials from Commonwealth, State and Territory health departments, and the NHMRC. The CTPRG seeks 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 CTPRG takes a strategic focus, and engages 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 to collaborate on awareness raising activities.
The current CTPRG Implementation Plan draws heavily on the Revitalised clinical trials agenda endorsed by all Health Ministers and has the following objectives:
- streamline coordination units and innovation;
- harness national networks and partnerships;
- improve clinical trials data and knowledge systems;
- embed research as essential health system business; and
- enhance capacity and consistency of ethics approvals.
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors is a joint statement that reflects the shared views of all state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG), of which all of these entities are members.
- COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors - PDF 462 KB
This guidance provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields.
The advice represents current thinking and best practice at the government level and will be reviewed and updated regularly to reflect changes in government policy, public health advice and the needs of those conducting and participating in clinical research in Australia.
Medicines Shortages Advice
The Medicines Shortage advice below reflects the shared views of all state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG), of which all of these entities are members.
Please note: Roche has advised us that the previously advised shortage of tocilizumab has now been resolved. Supply of intravenous (IV) and subcutaneous (SC) tocilizumab has returned to normal pre-pandemic levels.
Multi-Jurisdictional Multi-Party non Clinical Trial Collaborative Research Agreement
The Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement was endorsed by all jurisdictions at the Clinical Trials Project reference Group meeting held on the 13th April 2022. This follows extensive consultation across the research sector. This template agreement is non mandatory and follows the model of the Medicines Australia and Medical Technology Association of Australia suite of clinical trial research agreements. We kindly ask that you add a link to the template agreement on your website where other agreements are published and make it available to relevant parties for use in the appropriate manner. Please note than any change to any of the clauses shall be made between the contracting parties and their respective legal counsel in Schedule 1. Changes to clauses in this agreement will not be reviewed by the Southern Eastern Border States (SEBS) panel.
This agreement is designed to offer the non-clinical trials research sector the efficiencies realised in Australia when nationally accepted clinical trials contract templates were introduced.
If you would like the word version of the document, please contact AustralianClinicalTrials@Health.gov.au.