31 March 2020
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 664 KB
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors – Word 504 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.
Clinical trials benefit patients, advance medical knowledge and are estimated to be worth around $1 billion to the Australian economy each year. The environment in which clinical trials are conducted is complex, often occurring across multiple jurisdictions and with every study needing ethics and governance approvals before it can commence.
The Australian Government is leading a body of work to improve the Australian clinical trials environment with a view to improving health outcomes and increasing international investment in Australia.
The Department of Health is working through a range of government departments, committees, and industry stakeholders to progress improvements to the clinical trial environment. Much of this work is being achieved through collaboration between Commonwealth and jurisdictional agencies, including the Clinical Trials Project Reference Group (see below) and the National Health and Medical Research Council (NHMRC).
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 COAG Health Council revitalised clinical trials agenda (see below) 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.
COAG Health Council Revitalised Clinical Trials Agenda
While there have been sector improvements resulting from collaborations to date, there still remains work to be done to improve the environment for clinical trials in Australia. The goal remains to make Australia a preferred destination for clinical trials to benefit participants and stimulate jobs and business growth arising from health and medical research.
In April 2016 the Council of Australian Governments (COAG) Health Council noted that while jurisdictions have worked to improve the environment for clinical trials, issues of fragmentation and inefficiencies remain, that impact on Australia’s attractiveness as a preferred location for trials. Health Ministers agreed to develop approaches to organise sites to better support and streamline clinical trials processes in Australia.
In response to the April 2016 decision of the COAG Health Council noted above, the CTPRG developed a set of Principles and Priority Action Areas to underpin regional redesign of jurisdictional clinical trial systems. Priority Action Areas include:
- Coordination units – new models to centralise and coordinate trial management.
- Networks and partnerships – maximised collaboration with trial networks, communities of expertise/practice and registries, with an emphasis on cross-jurisdictional and discipline cooperation.
- Enhancement of data and knowledge systems – fast-tracked agreed metrics collection and improved data linkage capability, and support for mutual acceptance of ethical review.
- Research as essential health system business – embedding research and clinical trials into core hospital governance arrangements, including the use of performance measures.
- Embedding clinical trials in safety and quality approaches – collaboration with the Australian Commission on Safety and Quality in Health Care to establish a clinical trials governance framework to support research in public hospitals.
These Principles and Priority Actions were endorsed by COAG Health Council in March 2017 and provide a unique level of national agreement on priorities for streamlining of clinical trials processes, building national cohesion and advancing the clinical trials environment in Australia.
Jurisdictions and the Commonwealth are collaborating on key measures to address Priority Action Areas. This includes further strengthening Australia’s clinical trial sector using stimulus from the Australian Government’s Encouraging More Clinical Trials in Australia initiative, under which $7 million is available nationally to assist State and Territory governments achieve system redesign in accordance with the revitalised COAG Health Council clinical trials agenda. Among other things, this agenda seeks to establish central points of contact to improve system navigation for sponsors and participants, streamline trial processes and time to trial start-up, and improve workforce capacity.
Key Principles and Priority Action Areas – PDF 145 KB
Key Principles and Priority Action Areas – Word 36 KB
Read more about key CTPRG projects and key contacts here.
This information is sourced from the Australian Government Department of Health.
