The Government needs to invest in a proposed clinical trials infrastructure to ensure everyone has access to them and their benefits, argue Professor Lisa Stamp, Professor Frank Bloomfield and Dr Matire Harwood
Opinion: Clinical trials are a critical element of a modern, high-functioning, learning healthcare system, providing access to novel, unfunded treatments and delivering cutting-edge healthcare.
Evidence from clinical trials ensures healthcare is safe, allows disinvestment from practices that are found not to improve outcomes or be cost-effective and supports introduction of new approaches, all of which lead to improved health outcomes.
A notable example of a recent successful clinical trial was a Health Research Funded trial investigating the management of gout in Aotearoa, the results of which influenced international as well as local gout management guidelines.
However, Aotearoa New Zealand does not invest as it could, and should, in clinical trials, thus we do not realise the significant potential benefits of clinical trial research for people in our country.
In 2020, the Ministry of Health and the Health Research Council of New Zealand funded our research group’s project to understand the current state of clinical trial activity in New Zealand.
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Our aim was to determine which infrastructure would be required to support equitable clinical trial activity, to ensure that trials benefiting from publicly funded infrastructure are responsive to the needs of New Zealanders and ultimately enable equitable delivery of the best achievable healthcare across the country.
We propose the essential elements are a National Clinical Trial Infrastructure Centre that provides and manages some of the core functions and activities and Regional Clinical Trial Coordinating Centres that provide and manage operational functions and activities.
The value of clinical trials and health research to society is evident in aggregate health, social, economic, and system-level outcomes.
Individuals participating in a clinical trial experience personal health gain – through access to new treatments not funded by the government or additional health monitoring and care – and a sense of contributing to the future health of their community or altruism.
Healthcare and clinical trials funders typically focus on the return on investment that clinical trials undertaken within the public health care system bring.
Strong leadership will be required from the top of our health system down to ensure the required cultural shift to recognise the value of clinical trials to all aspects of the healthcare system and to grow capability and capacity of the health research workforce.
What is often neglected is that evidence that clinical trials and health research improve outcomes even for those not in the treatment arm by offering more systematic and consistent care.
Furthermore, hospitals that are more research-active achieve better overall patient outcomes than hospitals that are inactive in health research.
There are also significant financial benefits.
A 2014 examination of the Australian National Health and Medical Research Council expenditure estimated a benefit-cost ratio of 3.2:1 (ie for every AUD$1 of costs, there were between AUD$2.17 and AUD$5 of benefits) from AUD$10 billion of research and development funding.
These benefits included $1.3b of direct health system expenditure savings; a $7.7b reduction in burden of disease, and $1.9b reduction in productivity loss.
The value of investing in clinical trials is net positive for funders through improved health outcomes, cost avoidance, and effects that encourage wider private spending. Therefore, it is in health providers’ and funders’ best interests to support clinical trial activity.
The New Zealand healthcare system does not generally have a strong research culture, notwithstanding individual examples of excellence.
Research is not embedded within everyday practice or within the organisational structure, which does not facilitate research activity; indeed, in many cases, the system is a barrier to the conduct of research.
Additionally, the clinical research workforces are fragile with the Māori and Pacific research workforce particularly thinly stretched.
Kaupapa Māori health research is a vital mechanism for Māori to have tino rangatiratanga within research and maintain control and autonomy over the knowledge considered important and legitimate to Māori.
To realise clinical trials’ potential benefits and ensure everyone has equal access to participate in them, a system culture change supporting more capacity and capability in the Māori and Pacific health research workforce is needed.
The restructuring of the New Zealand health system into Te Whatu Ora (Health New Zealand) and Te Aka Whai Ora (Māori Health Authority) that will both operate hospital services and commission primary and community healthcare at a national level provides the ideal opportunity to integrate and embed research into New Zealand’s healthcare system.
Integration of clinical trials and research more broadly into the public healthcare system will require a significant shift in the culture within the system.
Research must be recognised and promoted as a core activity for clinical staff at all levels of the healthcare system.
Strong leadership will be required from the top of our health system down to ensure the required cultural shift to recognise the value of clinical trials to all aspects of the healthcare system and to grow capability and capacity of the health research workforce.
The investment required by government to implement the proposed clinical trial infrastructure will be substantial.
But now is the ideal time for investment in clinical trials infrastructure in Aotearoa.
We urge the Government to be bold and invest now to ensure the benefits can be reaped for all New Zealanders in years to come.
Professor Lisa Stamp, from the University of Otago, Christchurch, and Professor Frank Bloomfield and Dr Matire Harwood, from the University of Auckland, are principal investigators on the Enhancing Aotearoa New Zealand Clinical Trials Project Team.
