Stamp Lisa K, Harwood Matire, Dalziel Stuart, Love Tom, Moore David, Woock Kelvin, Sharples Katrina, Bloomfield Frank
Rheumatologist, Department of Medicine, University of Otago, Christchurch, Christchurch, New Zealand.
General Practitioner, Papakura Marae Health Clinic, and Department of General Practice and Primary Healthcare, Auckland, New Zealand.
N Z Med J. 2023 Jul 7;136(1578):100-112. doi: 10.26635/6965.6134.
Clinical trials are a critical element of a modern, high-functioning, learning healthcare system. Clinical trials provide access to novel, as yet unfunded treatments, and deliver cutting-edge healthcare. Evidence from clinical trials ensures appropriateness of healthcare, allows disinvestment from practices that are found not to improve outcomes or be cost-effective, and supports the introduction of new approaches, all of which leads to improvement in health outcomes. In 2020, Manatū Hauora - Ministry of Health and The Health Research Council of New Zealand funded a project to understand the current state of clinical trial activity in Aotearoa New Zealand and to propose the infrastructure required to support equitable clinical trial activity, in order 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 healthcare we can achieve to all New Zealanders. This viewpoint reports the process that was undertaken to develop the final proposed infrastructure and the rationale for the approach. The restructuring of the Aotearoa 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 Aotearoa 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 our healthcare system. Research must be recognised and promoted as a core activity for clinical staff at all levels of the healthcare system, rather than something to be tolerated or even hindered. Strong leadership will be required from the top of Te Whatu Ora - Health New Zealand 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 the 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 New Zealand. 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.
临床试验是现代、高效、学习型医疗体系的关键要素。临床试验提供了获得尚未获得资金支持的新型治疗方法的途径，并提供前沿医疗服务。临床试验的证据确保了医疗保健的适当性，允许停止对那些被发现不能改善治疗效果或不具有成本效益的医疗行为的投入，并支持引入新方法，所有这些都有助于改善健康结果。2020年，新西兰卫生部和新西兰健康研究委员会资助了一个项目，以了解新西兰临床试验活动的现状，并提出支持公平临床试验活动所需的基础设施，以确保受益于公共资助基础设施的试验能够满足新西兰人的需求，并最终使我们能够为所有新西兰人公平地提供所能实现的最佳医疗保健。本观点报告了制定最终提议基础设施的过程以及该方法的基本原理。新西兰医疗体系重组为新西兰健康局（Te Whatu Ora）和毛利卫生局（Te Aka Whai Ora），二者都将在国家层面运营医院服务并委托开展初级和社区医疗保健，这为将研究整合并融入新西兰医疗体系提供了理想契机。将临床试验及更广泛的研究整合到公共医疗体系中，需要我们医疗体系内部文化的重大转变。必须将研究视为医疗体系各级临床工作人员的核心活动并加以认可和推广，而不是将其视为一种可以容忍甚至受到阻碍的事情。从新西兰健康局高层到基层都需要强有力的领导，以确保实现所需的文化转变，认识到临床试验对医疗体系各个方面的价值，并提升健康研究人员的能力和数量。政府实施提议的临床试验基础设施所需的投资将是巨大的，但现在是新西兰投资临床试验基础设施的理想时机。我们敦促政府大胆行动，立即投资，以确保在未来几年所有新西兰人都能从中受益。
