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 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.
Encouraging More Clinical Trials in Australia – Central Points of Contact
Australian Capital Territory
ACT Health Directorate
Research Ethics and Governance Office
Email: email@example.com or firstname.lastname@example.org
New South Wales
Health Innovation, Investment and Research Office (HIIRO)
Department of Health and Human Services Victoria
Coordinating Office for Clinical Trial Research
WA Health Translation Network (WAHTN)
Clinical Trials and Data Management Centre (CTDMC)
Since its inception the CTPRG has:
- developed a program of work to address identified barriers in the current environment;
- agreed a framework for collection of national aggregate statistics on clinical trials that will be progressively implemented by all jurisdictions and facilitate a quality improvement approach to the sector;
- continued to work with the Department of Industry, Innovation and Science; the clinical trials sector; and the NHMRC to develop a comprehensive, national communications strategy to convey important messages about clinical trials;
- oversighted a study to investigate the issues, underlying barriers and enablers to recruitment and retention of patients to clinical trials, with a view to implementing effective change;
- developed and commenced work to implement a set of Principles and Priority Action Areas to underpin regional redesign of jurisdictional clinical trial systems and aligned with the Australian Government’s Encouraging More Clinical Trials in Australia initiative;
- commenced work, through the Australian Commission on Safety and Quality in Health Care, to develop a National Clinical Trials Governance Framework; and
- commissioned a review of the Australian New Zealand Clinical Trials Registry (ANZCTR).
Other projects are currently underway and further information will be provided when available.
National Clinical Trials Governance Framework
Development of a National Clinical Trials Governance Framework is a key element of the COAG Health Council revitalised clinical trials agenda and the CTPRG Implementation Plan. The Department has engaged the Australian Commission on Safety and Quality in Health Care to undertake this work on behalf of all jurisdictions.
The outcome will be a Clinical Trials Governance Framework, an important first step towards nationally consistent accreditation of health services undertaking clinical trials in Australia, which will ultimately be included in the National Safety and Quality Health Service Standards.
National consultations on a draft Clinical Trials Governance Framework were undertaken by the Commission in 2019. The sector is highly supportive of this initiative, which has the potential to significantly improve the environment for conducting clinical trials in Australia. Further information on this initiative is available on the Australian Commission on Safety and Quality in Health Care website.
Review of the Australian New Zealand Clinical Trials Registry (ANZCTR)
The ANZCTR is an online public registry of clinical trials and has the potential to be a key part of Australia’s clinical trials infrastructure.
On behalf of the CTPRG, the Commonwealth Department of Health procured Aspex Consulting to conduct a review of the ANZCTR in 2018 and to explore options for a potential next-generation registry. This review included extensive consultation with key stakeholders across the sector.
The Review of the Australian New Zealand Clinical Trials Registry report (Word 1138 KB) is currently being considered by the CTPRG and the Government.
The Department and the Australian Government is providing interim support to enable the continued operation of the existing ANZCTR while the next steps are under consideration.
National Aggregate Statistics (NAS)
The Framework for National Aggregate Statistics (NAS) and annual collection of NAS data through the CTPRG supports efficient government investment in reform efforts.
The NAS Report is made possible through the significant efforts and contribution of data by jurisdictions. It represents a substantial step forward in developing a national picture of clinical trials activity, and is crucial in monitoring and driving improvements to clinical trials and to promoting Australia’s public sector capability.
The NAS 1 Report (2014-15 data) reflected a new process and data collection methodology that captured commercial trials data only, and was not intended for publication.
The interim Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015-16 (Second Activity Report), developed under the Framework for National Aggregate Statistics (NAS Framework), was endorsed by Australian Health Ministers in June 2017.
The data captures the majority of new clinical trials approved in public health organisations in five jurisdictions in Australia. It includes the time taken for each of the two approvals needed for every clinical trial in Australia - ethics and research governance. The findings should be viewed as provisional, and part of continuous improvements efforts to strengthen capability. While the data captures the majority of new clinical trials approved, there are a number of missing data items. State and Territory governments are actively addressing these deficiencies, however it is not yet possible to estimate the impact on findings.
Key findings suggest that in public health organisations in Australia in 2015-16:
- over 700 new clinical trials were approved across five jurisdictions;
- new clinical trials were predominantly commercially sponsored;
- the majority of new clinical trials were Phase 2 or Phase 3; and
- start-up time for clinical trials was still longer than desired.
Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015–16 (PDF 514 KB)
Second Activity Report on Clinical Trials in Australian Public Health Institutions 2015–16 (Word 691 KB)
The NAS 3 Report represents all new clinical trials in public health organisations from six jurisdictions for the period 2014-2017. This report is the second NAS report to be made publically available, following previous AHMAC approval and public release of the NAS 2 Report (2015-16 data) in 2017.
Key findings were that in public health organisations in Australia over the reporting period:
- the majority of clinical trials were multi-site, Phase 3, and commercially sponsored;
- there were improvements in average approval times; and
- between 807 and 861 new clinical trials were reported each year.
Clinical Trials Collaborative Forum
The Clinical Trials Collaborative Forum focuses on a shared desire by the government, non-government and industry to make Australia a preferred destination for clinical trials.
The Forum was established following the joint meeting of CTPRG’s predecessor, the then Clinical Trials Jurisdiction Working Group (CTJWG) and the then Clinical Trials Advisory Committee (CTAC), held on 15 February 2017 to discuss options for meaningful future collaboration, and in recognition that no single entity controls all the levers to effect positive change across the clinical trials sector.
The Forum convenes twice a year and participation is by invitation only. The next meeting is scheduled for December 2019.
Report ‘Scoping and analysis of recruitment and retention in Australian clinical trials’
The Department of Health contracted Ernst and Young (EY) on behalf of the Clinical Trials Project Reference Group (CTPRG) to analyse issues around recruitment and retention in Australian clinical trials. These are complex issues because no single government or entity controls all the levers to effect positive change. EY was asked to provide advice on the best ways to enhance clinical trials recruitment in Australia, and undertook broad consultations as part of its research.
The EY Report includes a range of recommendations to boost clinical trials recruitment and retention in Australia. Some of the key recommendations call for collaborative government leadership, and establishment of dedicated structures to improve clinical trials coordination and administration across Australia. Many of the activities undertaken by the CTPRG are consistent with the recommendations from this Report.
Scoping and analysis of recruitment and retention in Australian clinical trials - Final report June 2016 (PDF 620 KB)
Scoping and analysis of recruitment and retention in Australian clinical trials - Final report June 2016 (Word 130 KB)
Critical Success Factors
The Department of Health contracted Health Outcomes International (HOI) to conduct an analysis of recently conducted clinical trials in Australia to determine the critical success factors and/or reasons for failure of clinical trials in Australia. The focus of the research was on pharmaceutical and medical device trials conducted within the last five years that were commercially funded and conducted across more than one jurisdiction. The project commenced in February 2015 and was completed in June 2015.
Analysis of recently conducted clinical trials – a study conducted by Health Outcomes International (HOI) (PDF 961 KB)
Analysis of recently conducted clinical trials – a study conducted by Health Outcomes International (HOI) (Word 678 KB)
Independent Hospital Pricing Authority’s (IHPA) determination
In 2013 the Department of Health funded the development of a table of standardised costs for conducting clinical trials in Australia. This work was first completed in 2013 by the NHMRC and the IHPA, but was subsequently revised based on stakeholder feedback.
The NHMRC prepared a revised list of clinical trial items and the IHPA released its Determination on 30 September 2015. The primary objective in developing the determination was to improve transparency of clinical trial costs and enhance efficiency of contract negotiations. Use of the Determination is not mandatory. Rather, the Determination is intended to serve as a reference point to negotiate price, and sites and sponsors can adapt the Determination based on trial-specific circumstances.
The final Determination is available on the Independent Hospital Pricing Authority website.
In 2015 the then Clinical Trials Jurisdictional Working Group (CTJWG) consulted with industry stakeholders through liaison meetings held in Sydney and Melbourne to share and test CTJWG’s identified priorities and work program. The purpose was to harness the experience and perspectives of contract research organisations (CROs) and front-line industry representatives and gain a better understanding of their current priorities for the clinical trials sector.
Clinical Trials Jurisdictional Working Group - Sydney and Melbourne Industry Liaison Meetings (PDF 735 KB)
Clinical Trials Jurisdictional Working Group - Sydney and Melbourne Industry Liaison Meetings (Word 42 KB)
Other useful Initiatives and programs