Proposed reforms to the Australian clinical trials sector aim to bring research in from the margins in healthcare settings.
This article is published by Croakey Professional Services as sponsored content. It is funded by The Australian Commission on Safety and Quality in Health Care.
Proposed reforms to the Australian clinical trials sector aim to bring research in from the margins in healthcare settings, improve the overall standard of hospital care, and support the retention of medical researchers in our healthcare system.
The National Clinical Trials Governance Framework, a key component of these reforms, is currently being developed by the Australian Commission on Safety and Quality in Health Care (the Commission). It aims to give Australian patients more access to life-saving treatments and medications by cementing our competitive edge in the global marketplace.
The framework will allow hospitals and health services delivering clinical trial services to meet streamlined minimum standards – a first step towards undergoing formal accreditation to provide clinical trial services.
The draft framework recognises that governing bodies, hospital administrators, clinician trial investigators, clinical and non-clinical site staff – working in partnership with patients, trial sponsors, regulators, and consumers – have individual and collective responsibilities for delivering clinical trial services. Achieving the minimum standards will encourage a more strategic approach to the delivery of trials across multiple clinical departments.
The Commission has consulted on the draft framework with stakeholder groups across Australia. The framework will be progressed for agreement by the Australian Government Department of Health and all states and territories before its implementation.
Building on Australia’s success
The Commission’s Chief Medical Officer Dr Robert Herkes said the framework is a key element of a clinical trials agenda endorsed by all Health Ministers in 2017, to better engage trial sponsors such as pharmaceutical companies, reduce administrative inefficiencies, and improve trial start-up times.
Dr Herkes said that the market place for clinical trials is global. Currently, some inconsistencies between health services and jurisdictions, and delays in start-up times due to duplication and varying approval processes reduce Australia’s competitive advantage. While clinical trials in Australian have some inherent challenges, including higher costs when compared to some countries and a smaller population pool, these challenges can be overcome.
“Australia is a strong performer globally in clinical trials, and Australian researchers have delivered some huge trial successes, including the development the Gardasil human papilloma vaccination (HPV) and Relenza (Zanamivir), the first drug to treat all influenza strains,” said Dr Herkes.
The framework builds on this success, and will ensure that Australia’s reputation as a leading destination for clinical trials is enhanced. It means that going forward we will continue to compete with Europe and Asia which have invested heavily in quality trial processes and clinical trials infrastructure.”
“Not addressing these quality factors may make it harder for us to compete in the future. Sponsors will go to places where they can get trials up and running quickly and deliver good trial data.”
Clinical trials: a worthwhile investment
Globally, there is intense competition and much at stake in being a preferred location for clinical trials.
A 2017 report by the Australian New Zealand Clinical Trial Registry found that Australia ranks in the top tier of national clinical trial activity with more than 10,000 clinical trials conducted between 2006 and 2015; with cancer being the most frequently studied health issue.
A joint report released by the Commission and the Australian Clinical Trials Alliance found that the cost of clinical trials is outweighed almost six-to-one by the savings that flow from the health improvements experienced by patients, and the direct savings to the health system and wider economy.
With more than $1 billion invested in Australian clinical trials each year by industry (estimated at $930 million in 2016) and government ($100 million), this represents not only great value for money, but more importantly, a hugely beneficial outcome for Australian patients.
However, those benefits are not necessarily understood in all health services and by hospitals that are already under budget and resource pressure to deliver services.
Dr Herkes said that hospital management and boards can sometimes see clinical trials as “a siloed, ad hoc add-on,” rather than as integral to service provision, patient outcomes, specialist recruitment and a robust health system.
Professor Erwin Loh, a member of the framework Steering Committee and Chief Medical Officer and Group General Manager Clinical Governance for St Vincent’s Health Australia, says Australian researchers “punch above [their] weight” in clinical trials.
They conduct a high number of trials, have significant international participation and are often principal investigators in well-known global trials, he said.
He agrees however, that these advantages are countered by higher costs, lack of consistent standards, and the lack of a positive research culture in many health services.
Professor Loh’s role covers clinical trials conducted at St Vincent’s six public hospitals and ten private hospitals, working closely with three co-located research institutes – the Victor Chang Cardiac Research Institute, the Garvan Institute of Medical Research, and St Vincent’s Institute of Medical Research. He was previously Chief Medical Officer and Executive Director of Innovation, Patient Safety and Experience at Monash Health.
He is confident the proposed framework will not duplicate processes that already exist for researchers, particularly around ethics. Without these changes, he said we risk relegating clinical trials to the margins and leaving small teams of researchers to initiate, source funding and manage with varying capabilities, organisational support and oversight.
Frequent issues for investigators and sponsors – including seeking local site-specific assessment of an approved trial to be undertaken at a hospital, and the constant renegotiation of even the most basic costs, such x-rays and blood tests – can potentially add months to the hospital approval process, frustrating both researchers and sponsors, said Professor Loh.
“These common problems can have a measurable impact on patient care, such as in oncology where therapies are frequently provided through clinical trials,” he said.
At the core of the draft framework, is the intention to streamline processes that have led to waste and delays. Currently, in a lot of places, costs are renegotiated for every trial – every trial is different, in every hospital, in every specialty,” Professor Loh said. “It shouldn’t be like that, it should be standard and transparent.”
He expects the framework will require hospital managements to take a helicopter view of how much they invest in staff, time and skills to remain accredited for clinical trials.
This process will help with prioritisation and prompt hospital management to consider whether they need to look to partners for additional support.
It may also lead to greater calls for dedicated funding for clinical trials, one of the priorities for reform highlighted by the Clinical Oncological Society of Australia and Cancer Council Australia.
The draft framework also aims to embed processes to ensure that Aboriginal and Torres Strait Islander people and those from culturally and linguistically diverse (CALD) backgrounds are not disadvantaged in research, either by being excluded or through a lack of cultural safety.
“At the moment there is no external assessment of that. It’s voluntary, and up to each hospital to check. I’m not sure that many places put their minds to that really, so it’s important to include that criteria,” Professor Loh said.
Positioning our clinical trials sector for success
In March 2017, the Council of Australian Governments (COAG) Health Council agreed to strengthen Australia’s clinical trial sector through a new revitalised agenda for reform.
Among the priorities was the embedding of research and clinical trials into core hospital governance arrangements and into safety and quality requirements.
The draft framework describes what is expected in the standard for clinical trials and provides clarity on roles and functions of identified positions within hospitals delivering clinical trial services. It also provides actions against which it is proposed that health service organisations will be assessed for accreditation and allows for flexibility by not specifying how hospitals should develop or implement their clinical trial governance systems.
The standards within the new framework will become part of the requirements of the National Safety and Quality Health Service Standards (NSQHS), for those that provide clinical trial services in Australian public and private hospitals.
Dr Herkes said that once a clinical trial service is accredited under the new framework, it will be recognised as having quality trial processes and infrastructure. Hospitals or health services that do not meet the new standards outlined in the new framework may ultimately find it difficult to conduct clinical trials.
The National Clinical Trials Governance Framework’s overriding aim, he said, is to address operational and administrative burdens with a strategic approach to clinical trial governance across health service organisations.
Achieving this will better position the Australian clinical trials sector for continued success, and allow us to directly benefit hundreds of thousands of Australian patients in the decades to come.”
“Developing The National Clinical Trials Governance Framework, and making the delivery of a service an organisation-wide responsibility is, I think, a game-changer,” he said.
To provide input or to ask questions about the draft framework, contact the Commission project team on (02) 9126 3517, or CTGovernance@safetyandquality.gov.au.
*This article was written by Marie McInerney and edited by Ruth Armstrong, on behalf of Croakey Professional Services. It was sponsored by The Australian Commission on Safety and Quality in Health Care, which had final say over the content.
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