The Enhancing Aotearoa New Zealand Clinical Trials report released last month states
Clinical trials are a central element of a modern, high-functioning health system. Clinical trials can provide access to novel treatments for patients and deliver cutting-edge healthcare. Further, investment in clinical trials allows for efficient healthcare and provides health sector returns in excess of the dollars invested. The evidence generated by clinical trials is used to improve our health services, ranging from public health and prevention interventions through to specialised medicines and novel devices. Clinical trial research increases the efficacy and efficiency of care, thereby bettering the health of New Zealanders.
While there are examples of high-quality research, Aotearoa New Zealand does not invest as effectively as it could, and should, in clinical trial research. We do not realise the significant potential benefits of clinical trial research for the people of Aotearoa New Zealand and those benefits that are realised are distributed inequitably because of the current health system’s fragmentation and rigidity, and because clinical research is not embedded within it as part of a learning healthcare system. To respect Te Tiriti o Waitangi and meet obligations as a treaty partner, it is critical that we have clinical evidence of the efficacy and safety of healthcare interventions for Aotearoa New Zealand’s population, especially Māori. This project proposes a future direction for developing infrastructure that will support equitable clinical trial activity, ensure that trials (including commercial ones) benefiting from publicly funded infrastructure are responsive to the needs of New Zealanders and ultimately enable the equitable delivery of the best healthcare we can achieve to all New Zealanders.
This report is the outcome of independent research funded by the Health Research Council of New Zealand and Manatū Hauora | Ministry of Health.
This project was conducted by a diverse group of clinical researchers from a range of backgrounds and disciplines and involved a specific Māori Rōpū, a Pacific advisory group and a consumer group. It also consulted a group of international researchers. The project reported to an expert steering group appointed by the Ministry of Health (MOH) and the Health Research Council (HRC).
The project proceeded with a characterisation of the current state of clinical trial activity, both in Aotearoa New Zealand and in terms of international practice. We collected information from the Australian New Zealand Clinical Trials Registry (ANZCTR), conducted a survey of researchers, carried out 58 individual and group interviews, and met with the Māori Rōpū, Pacific advisory group and consumer group. This information was reviewed by iNZight Analytics through the Te Ao Māori lens.
Current-state findings were reviewed by many stakeholders in a workshop at which approaches for improving the clinical trial infrastructure in Aotearoa New Zealand were canvassed. These approaches formed the basis for a modified sector-wide Delphi process to find consensus on a variety of clinical trial infrastructure options. Options that were supported in the Delphi process formed the basis for the research team to propose a preferred model for the infrastructure needed to support clinical trials and achieve benefit from them for the people of Aotearoa New Zealand. Clinical trial research is a barometer for health research activity in general. High-quality clinical trial research gains will only be realised with a functioning and supported health research infrastructure. Thus, while this project is focused on clinical trial research, a number of the recommendations (for example, those targeting improving research leadership, knowledge translation or data governance) apply to health research activity more broadly. Therefore, actioning the recommendations contained within this report will achieve gains within a wider context of health system research, innovation, and improvement.
Current-state findings
The main findings of our current-state analysis were:
• The New Zealand health system does not generally have a strong research culture, notwithstanding individual examples of excellence. Health system decision-making often does not facilitate research activity and, in many cases, can be a barrier to the conduct of research.
• Prioritisation of clinical trials, in the sense of funders systematically considering what research will reduce inequities and bring benefits for New Zealanders, is rarely practised outside of the HRC.
• There is great diversity in existing clinical trial activity across different kinds of health intervention, different phases of intervention development, and different settings.
• Institutional settings for clinical trials vary significantly across philanthropic organisations, universities, district health boards and community health organisations. Within the window of our stakeholder and current-state analysis, few trials have been conducted in Māori health provider settings and none in Pacific provider settings.
• There is a gap in partnership with Māori, both in the design and conduct of individual trials, and in the wider infrastructure of trial activity, including in the management of data and tissue samples with appropriate tikanga.
• There is a need for clinical trial methodologies and conduct to be more responsive to Māori needs, and more sensitive to cultural requirements.
• Consumers have a rapidly growing role in clinical trials and in making sure research is relevant and meaningful. Through the consultation process we have heard there is a need to create more opportunities for consumers to be research partners.
• Clinical research workforces are fragile.
• The Māori clinical research workforce is particularly thinly stretched, with barriers to development and support for those wishing to pursue a research career.
• There are examples of good access to key infrastructure, such as statistical advice, or experienced research nurse support, but that access is very patchy, making this an important barrier to undertaking research and to development of a sustainable research workforce.
• Existing clinical trial networks provide critical support for researchers, enabling high-quality success, but they are fragile and not resourced sustainably.
• Information needs are changing, data governance processes are diverse and often not systematic, and there is little guidance on data sovereignty.
• There is relatively little focus on translation of research results into practice. Translation is a particular issue for Māori given the extractive nature of research, the need to tailor results for Māori providers, and a need to show Māori reasons to become involved in trials.
• Accurately costing and adequately funding clinical trials and clinical trial development is difficult, and the ability to conduct a long-term clinical trial (>3 years) within existing funding caps is problematic. ...
There is a strong case for significant investment in a national clinical trials infrastructure in Aotearoa New Zealand. These general recommendations form the foundations for a proposed infrastructure to harness the potential of clinical trials within Aotearoa New Zealand’s healthcare system.
• The national clinical trials infrastructure must be underpinned by principles of Te Tiriti and developed in co-governance with Māori.
• The responsibility for ensuring high-quality research activity must be woven into the job descriptions of all senior clinical leaders in Health NZ and the Māori Health Authority. There must also be targeted measures of accountability for these senior clinical leaders.
• There must be an adequately resourced National Research Office for Health NZ, co-governed with the Māori Health Authority, with research leadership at the executive level of the organisations. While this function exists within the context of health research policy leadership from the Ministry of Health, in order to envisage possible gains it is essential for Health New Zealand to have research leadership at the operational level.
• There should be a National Clinical Trial Infrastructure Centre with expertise from across the country, which will provide leadership, governance, expertise, and overall, high-level national support and coordination of trial activity, including the support of clinical trial networks in Aotearoa New Zealand ...
• There should be Regional Clinical Trial Coordinating Centres around the country that between them provide the necessary expertise to support clinical trials as outlined in section 5.3 of this report. Each of these centres will support trial development and conduct across regional nodes to ensure equity of access for both researchers and participants and will collaborate with other centres to support local, regional, national, and international trials.
• There should besustainableandsystematicnetworks for Māori researchers and for Pacific researchers to support Māori and Pacific research communities in a regular and coordinated way in accordance with recommendations and priorities identified above.
• Active development and support for the Māori health research workforce to meet commitments to Te Tiriti and to reducing inequities in health.
• Partnership with Māori and local Māori communities at every level, including trial implementation and national infrastructure.
• Supporting Te Ao Māori methods/priorities and engagement with researchers and communities.
• Embedding Māori data sovereignty and tikanga about data in the clinical trials system.
• Ensure knowledge translation has a positive impact for Māori and reduces inequities in health outcomes.
• When funding mechanisms are developed, ensure they are responsive to Māori community needs and researcher obligations.
• Support and train tauiwi workforce to engage with Te Ao Māori.
• Active development and support for the Pacific health research workforce.
• All publicly funded clinical trials should include consumer research partners.
• There should be a national federated health data system with Māori data governance at the core, that allows embedding of research in routine clinical care and provides culturally appropriate long-term curation of research data.
• A clear responsibility for research knowledge translation and implementation must be established within Aotearoa New Zealand’s new healthcare system that is well integrated with change management, clinical governance functions, and the health system’s role and responsibilities as an effective Te Tiriti partner for Māori.
These recommendations were developed from consistent needs and themes across the project and from all those consulted. In addition, specific recommendations from the Māori Rōpū and Pacific and consumer groups (see section 6.2) further identify priorities to ensure their needs are meet by the preferred infrastructure model.
Preferred model
Our preferred infrastructure model will address the recommendations made by our extensive groups of stakeholders. Our proposal consists of two main components:
• A National Clinical Trial Infrastructure Centre that manages some of the functions and activities that have been agreed to be critical through the Delphi survey process.
• Multiple Regional Clinical Trial Coordinating Centres, procured by the National Clinical Trial Infrastructure Centre, that manage operational functions and activities at local level or across specific communities on behalf of the centre. Supporting organisations may be consortia or could contract other organisations as suppliers for necessary resources.
We have identified a detailed set of functions and activities to be provided across the National Clinical Trial Infrastructure Centre and the Regional Clinical Trial Coordinating Centres. We envisage that the National Clinical Trial Infrastructure Centre will be an integral part of the newly developing Health New Zealand and Māori Health Authority, with the capability and resources to influence their culture to develop a genuinely learning health system for the benefit of all people in Aotearoa New Zealand. The research leadership must be closely integrated with leadership in clinical governance and quality, innovation and change management, and the professions in order to achieve the promise of improved healthcare based upon high-quality evidence that is relevant for New Zealanders.
