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New report sheds light on clinical trial activity in New Zealand

Media Release
A new report by the Australian New Zealand Clinical Trials Registry (ANZCTR) provides a comprehensive profile of clinical trials in New Zealand registered between 2006-2015.

The report ranks New Zealand within the top tier internationally of trials per capita, with about 2,500 clinical trials conducted during the decade.

These trials ranged from single-site New Zealand-only trials through to multinational mega-trials. A total of 1.6 million participants were enrolled, taking into account the New Zealand and overseas arms of the trials. More than 50% of trials in NZ were multinational, and Industry was involved in 55% of registered clinical trials. The most frequently studied health issues were cancer, cardiovascular disease and respiratory diseases.

The Health Research Council of New Zealand (HRC) supports registration of all New Zealand health research and has been the key contact for the ANZCTR since its establishment in 2005. The HRC alone has contributed more than $94 million to clinical trials in New Zealand within the timeframe captured in the report.

“Clinical trials are a pillar of an effective and efficient health system, and this report provides unprecedented detail on the landscape of clinical trials in New Zealand,” says Professor Kath McPherson, chief executive of the Health Research Council of New Zealand.

“The data show that clinical trial activity in New Zealand is high by international standards and has risen significantly over the decade, providing vital evidence for health sector decision-makers, opportunities for health professionals to engage in research, and enabling New Zealanders to access the best available healthcare options.”

She adds that the high rate of international collaboration, as reflected in this report, brings benefits to New Zealand by providing access to larger participant numbers and more conclusive answers to important questions. It also means patients can access treatments that aren’t yet in usage in New Zealand. “This report demonstrates that the value of the ANZCTR exceeds its core purpose to enable fulfilment of ethical requirements. The Registry also provides data to identify national trends, strengths and opportunities to inform the future health research agenda,” says Prof McPherson.

“We welcome the high-quality data collection that’s enabled this report and encourage New Zealand researchers to continue to register their trials and update their data throughout the lifecycle of the trial.”

The report draws upon data collected through the ANZCTR and ClinicalTrials.gov, which combined are estimated to capture 82% of registered trials with New Zealand sites.

Key findings of the report:

·         During the decade 2006-2015, clinical trial activity in New Zealand has been substantial, with 2,485 clinical trials conducted with one or more New Zealand sites. More than 1.6 million participants were enrolled, taking into account the New Zealand and overseas arms of the trials.

·         On a per capita basis this level of activity compares favourably with other countries internationally, with New Zealand being in the top tier of national clinical trial activity; above Australia, Norway, Ireland, Canada, and the UK, for example, and below Denmark.

·         A large proportion of New Zealand clinical trials are multinational (51% compared to 33% for Australian trials), demonstrating a high degree of international connectedness and collaboration. Australia is the top collaborator with New Zealand, but other countries that New Zealand trialists have a high level of collaboration with include the United States, Canada, Germany and the United Kingdom.

·         A greater proportion of New Zealand trials have industry involvement compared to Australian trials (55% versus 45% respectively). A range of non-commercial funders in New Zealand also support clinical trials.

·         Clinical trials in New Zealand assess multiple types of interventions, including drug treatments (52%), surgery (4%), medical devices (13%), behavioural therapies (6%) and prevention strategies (9%). The range of activities includes large multicentre phase 3 trials that are likely to impact clinical practice directly, as well as early-phase trials testing novel therapies or interventions that may become the new best treatments of tomorrow.

·         There has been proportionally more activity in the areas of greatest national disease burden, with the most common disease areas studied in New Zealand clinical trials being cancer, cardiovascular disease and respiratory diseases, representing 15%, 13% and 11% of all trials, respectively. However, some areas of high disease burden such as musculoskeletal disorders, mental disorders, and injuries remain under-represented.

·         The decade has seen several interesting national trends in registration of clinical trial activity:
- Moderate growth in the total number of trials registered each year, mainly reflecting increases in smaller-scale trials and non-drug interventions.
- Increase in the number of New Zealand trials registered prospectively (i.e. before enrolment of the first participant) with this sitting at around 75% at the end of the decade.
- A marked increase in phase 1 trials as a proportion of clinical drug trials registered over the decade, from 6% in 2006 to 30% in 2015.
- The absolute number of New Zealand registered trials sponsored by the commercial sector has increased over time.
- Reduction in trial size over the decade – from a median of 230 participants per trial down to 80. This may reflect appropriate changes in design for more targeted therapies or, conversely, inappropriate reductions in sample size resulting in trials that are underpowered to detect significant, but moderate, treatment benefits. This is an area which warrants further in-depth assessment.
· Along with this good news, the report highlights that New Zealand has huge potential to grow capability and capacity for clinician-led trials in the non-commercial sector, for example comparative effectiveness research, non-drug interventions (such as behavioural therapy), and interventions for more effective prevention and diagnosis. We also need to increase our understanding of which clinical trials have resulted in translation of evidence for the benefit of patients and/or the broader community.
New MSD-HRC Research Partnership Projects

Media Release

The Health Research Council of New Zealand (HRC) and Ministry of Social Development (MSD) are pleased to announce that funding has been offered to the following recipients through the 2018 MSD-HRC research initiative.

This is a new partnership with the Ministry of Social Development to fund high-quality research that will identify innovative approaches for case management services to help achieve improved employment outcomes for people with health conditions or disabilities.

2018 MSD-HRC Research Partnership recipients:

Dr Joanna Fadyl, Auckland University of Technology

Support for gaining employment for people with a long-term condition

18 months, $316,433

Lay summary:

A robust systematic review that is contextualised for the Aotearoa / New Zealand service delivery context is crucial in order to utilise the best evidence available to develop innovative case-managed support to gain employment for people experiencing health conditions or disability.

This systematic review will combine robust review methodology with input from stakeholder reference groups, targeted to questions of clear relevance to the Ministry of Social Development. The review questions focus on which employment support interventions have robust evidence of effectiveness but also seek key contextual information from studies that may inform implementation and direct further research of critical value. The stakeholder reference groups will ensure high relevancy of the search as well as informed interpretation of findings that are grounded in local context. This design is supported by a research team with a proven track record in both research and implementation in this field for prompt application of findings.

Ms Helen Lockett, Te Pou o te Whakaaro Nui, in partnership with Work Counts and Synergia

Development of cross-agency collaboration to improve employment outcomes

24 months, $474,949

Lay summary:

People who experience mental health or addiction problems are much less likely to be in employment than people who do not. Māori and Pasifika peoples who experience mental health or addiction problems are further disadvantaged when trying to find or keep employment. Yet these issues are not a reflection of peoples’ employment aspirations.

Effective collaboration between welfare, employment and health agencies is crucial to address these inequities. Collaboration promotes access to financial support when people are not working, and the right type and intensity of employment assistance to enable the person to regain employment.

Using a case study design, this research will identify models of successful collaboration between Work and Income case management services and contracted employment support providers. It will identify approaches to collaboration that successfully support people with addiction or mental health problems, particularly Māori and Pasifika peoples, to return to, and stay in, employment. The research will identify the approaches used by successful models of collaborative case management in order to help organisations transfer these approaches to other contexts and populations.
Matire Ward

Māori Health Scholarship could bring life to rarely-used fertility treatment

Media Release

A Victoria University of Wellington researcher hopes to improve the success of a fertility treatment that’s rarely used in New Zealand but may potentially provide a safer alternative to current artificial reproductive technologies (ART).

Matire Ward of Te Matarahurahu hapū and Te Kotahitanga Marae in Kaikohe has just been granted a Māori Health Research PhD Scholarship, valued at $113,791, in the Health Research Council of New Zealand’s 2019 Career Development Awards. She will be working under the supervision of Dr Janet Pitman, who focuses on factors that make a good egg.

Ward aims to improve the process of in vitro maturation (IVM), in which eggs are retrieved while still at an immature stage and brought to maturity in the laboratory (in vitro). The process differs from conventional in vitro fertilisation (IVF) which utilises medications to bring a patient’s eggs to maturity before they are removed from the ovary.

Ward claims that IVM is safer than conventional IVF as the treatment doesn’t rely on ovarian stimulation which may result in ovarian hyperstimulation syndrome (where ovaries become swollen and painful). However, the use of IVM in fertility clinics remains controversial due to the reduced quality of embryos derived from in vitro matured eggs. For this reason, the practice is still rare in New Zealand, with the first baby only conceived in 2013.

"The main issue is that current IVM methods produce lower-quality embryos. We're taking an immature egg from its natural environment and putting it in this foreign environment in the lab," says Ward.

The secret to improving the treatment’s success could be in mimicking, within a Petri dish, the natural physical environment of ovarian follicles in which eggs would normally mature, she says.

As a follicle matures, an area within it fills with fluid, says Ward. The nutrients, including glucose, carbohydrates, hormones, and growth factors present in this fluid are transferred to the egg by its surrounding support cells. This transfer is critical for optimal egg development and maturation.

When cells are cultured in a dish in the lab, these nutrients are provided at concentrations very different to what is found in follicular fluid.

Using cow’s eggs for her investigations, Ward will prepare and test nutrients at concentrations similar to that of follicular fluid. She will then investigate the key molecular and metabolic pathways that are altered when immature eggs are exposed to these nutrients, in order to develop an improved IVM system that produces high-quality embryos.

Ward says refining this therapy may give another treatment option to couples concerned about, or at risk of, hyperstimulation syndrome.

She also aims to have conversations with Māori about the use of ART and how her research might mitigate commonly-held concerns about fertility treatments. “While Māori opinion on these types of therapies is conservative, it’s of upmost importance to all Māori people that their whakapapa is continued in a way that regards tikanga,” she adds.

Ward is the first in her family to undertake tertiary education, but says she is quite used to being surrounded by science. "My mum is a science technician and throughout my childhood, I would often accompany her to the laboratory.”

She says this scholarship will be a foot in the door to get into postdoctoral research involving assisted reproductive technologies in women. “I hope to continue researching in fertility clinics worldwide to expand my research capabilities and then come home to establish myself as a leading reproductive health researcher joining the few Māori women in this research field.”

Matire Ward is one of 19 researchers to receive a 2019 HRC Māori Health Research Career Development Award.

Mr Stacey Pene, the HRC’s senior manager of Māori Health Research Investment, says these Awards are key to building capacity and capability within the Māori research workforce.

“Māori researchers are tackling complex scientific questions and public health issues that will improve Māori health and wellbeing, and benefit New Zealand as a whole. We’re incredibly proud to support researchers who are making a significant contribution to knowledge and a genuine difference to their communities,” he says.

See below for the full list of recipients, and click here for lay summaries.

2019 HRC Māori Health Research Career Development Awards

Māori Health Research Postdoctoral Fellowship

Dr Megan Leask, University of Otago (General Fellowship)

Reducing the burden of Metabolic disease in Māori

24 months, $284,599

Māori Health Research PhD Scholarship

Mrs Sonia Hawkins, The University of Auckland

Racial and ethnic bias among registered nurses

36 months, $128,899

Mrs Marie Jardine, The University of Auckland

Deglutition (Swallowing) in advanced age

24 months, $75,196

Ms Ngahuia Mita, University of Otago

Tairāwhiti waka, Tairāwhiti tangata – Examining Tairāwhiti voyaging philosophies

36 months, $141,364

Ms Emerald Muriwai, The University of Auckland

Nga kaiwhakaako, whakapakari tinana me te hauora hinengaro

36 months, $107,000

Ms Marnie Reinfelds, The University of Auckland

Ka Ora – Exploring the Healing Potential of Birth

36 months, $128,899

Miss Matire Ward, Victoria University of Wellington

The impact of micro-environment composition on oocyte developmental competency

36 months, $113,791

Māori Health Research Masters Scholarship

Mrs Nicola Canter-Burgoyne, Massey University

Māori experience of using CPAP treatment for OSA

24 months, $26,600

Miss Abigail Johnson, University of Otago

Physiological changes to cerebellar Purkinje neurons in Parkinsonian rats

12 months, $30,253

Ms TeWhaawhai Taki, The University of Auckland

Te Tino Rangatiratanga o te Mate Ikura Roro

24 months, $25,190

Māori Health Research Development Grant

Dr Isaac Warbrick, The University of Auckland

Te Maramataka – Improving oranga through environmental matauranga

6 months, $10,000

Māori Health Research Summer Studentship

Miss Manurereau Te Maunga-A-Rongo Allen, University of Otago

Tane Māori access to and perceptions of primary care

10 weeks, $5000

Mr Zaine Akuhata-Huntington, University of Otago

Māori rangatahi suicide – informant perspectives on determinants and solutions

10 weeks, $5000

Te Aomarama Anderson, Te Puawai Tapu Trust

Rights-based approaches to Māori health: A Kaupapa Māori review

10 weeks, $5000

Ms Ellie Baxter, University of Otago

Qualitative analysis of Māori patients' primary health care experiences

10 weeks, $5000

Miss Kathryn Hippolite, University of Otago

Exploring Māori health provider workers’ perspectives of medication challenges

10 weeks, $5000

Miss Rebekah Laurence, Te Puawai Tapu Trust

Māori women and abortion: A Kaupapa Maori review

10 weeks, $5000

Miss Esther Pinfold, University of Otago

Pharmacokinetics of Benzathine Penicillin G in children and young people in NZ

10 weeks, $5000

Ms Maia Tapsell, University of Otago

An environmental scan of Indigenous oral health providers

10 weeks, $5000
Dianne Sika-Paotonu

Simpler cancer testing a potential lifeline for Pacific patients

Media Release

A simpler means of cancer diagnosis and monitoring, using small fragments of tumour DNA circulating in the bloodstream, could be a lifeline for Pacific patients in particular.

Dr Dianne Sika-Paotonu, Associate Dean (Pacific) at the University of Otago, Wellington, has just been awarded a Pacific Health Research Career Development Award by the Health Research Council of New Zealand (HRC).

With her $195,162 Sir Thomas Davis Te Patu Kite Rangi Ariki Fellowship, she will investigate the potential use of a simple blood test to identify circulating tumour DNA (ctDNA) for the purpose of detecting cancer at an earlier stage.

Circulating tumour DNA (ctDNA) refers to small fragments of tumour DNA found in the blood circulation, recognised by the presence of mutations in cancer genes.

Work in New Zealand led by Professor Parry Guilford, and supported by the Healthier Lives National Science Challenge, has demonstrated that these DNA fragments can be isolated and quantified to obtain information about a cancer's size and progression – so they can tell us how a tumour is behaving.

Dr Sika-Paotonu says there are also indications that ctDNA technology could be extended to develop a simple blood test to detect cancer, which does not require a hospital visit. This will enhance the precision of cancer diagnostics and surveillance, and lead to improved health outcomes for Pacific people by allowing earlier diagnosis and treatment.

Tumours are usually picked up using biopsies, but Dr Sika-Paotonu says this can be a significant barrier to care in Pacific countries where access to healthcare is limited and the cancer burden is growing.

"Sometimes it’s not that easy to get to a tumour and take a biopsy. Most biopsies will require some level of surgical intervention, so that compared to a blood test is a very striking difference,” she says.

"Instead of using ctDNA technology to only monitor treatment progress, we're trying to target the beginning stages and detect cancer at a much earlier time-point when it is more likely to be treated successfully."

While development work in this area is still required, Dr Sika-Paotonu will explore the applicability of this potential technology in resource-constrained environments.

Diagnostic methods are difficult to access in the Pacific region and treatment options are limited and expensive, she says. Often cancer is picked up late and palliative care becomes the only remaining option for many people.

Dr Sika-Paotonu will engage with Pacific health professionals, practitioners and Pacific participants within New Zealand, Tonga, Samoa and the Cook Islands. “In addition to this research work being Pacific-led, it is absolutely essential that Pacific voices and perspectives are represented and included in a way that will help guide the direction of this work moving forward.”

She adds that the career development award is part of fulfilling a promise she made as a child. "When I was little I promised my mother I was going to cure cancer – and of course she keeps reminding me of my promise, so I’ve always gravitated towards cancer research.”

The HRC has supported Dr Sika-Paotonu on a number of research projects to date, where she’s developed her strengths and commitment to reducing health inequities.

The HRC’s manager of Pacific Research Investment, Tolotea Lanumata, says it’s important to support biomedical researchers who explore problems and solutions in partnership with those they’re trying to help.

“Dianne’s approach on this project is to understand the perspectives and experiences of Pacific people with cancer, in order to ensure that any new diagnostic method will not only be clinically relevant but also address barriers to care that Pacific people currently face.”

The HRC today announced 22 Pacific Career Development Awards worth $1,548,043. See below for the full list of recipients.

2019 HRC Pacific Health Research Career Development Awards

Sir Thomas Davis Te Patu Kite Rangi Ariki Fellowship

Dr Apo Aporosa, University of Waikato

Improving road safety and health: understanding kava’s impact on driver fitness

30 months, $278,018

Dr Dianne Sika-Paotonu, University of Otago

The applicability of ctDNA as a diagnostic tool for early cancer detection

24 months, $195,162

Pacific Clinical Research Training Fellowship

Ms Soana Muimuiheata, Auckland University of Technology

Food and diabetes: the underlying factors that determine food practices of Tongan people

24 months, $222,433

Dr Malama Tafunai, University of Otago

Prevalence of Chronic Kidney Disease in Samoan residents in New Zealand and Samoa

36 months, $320,000

Pacific Health Research PhD Scholarship

Ms Heimata Herman, The University of Auckland

Health-related policies in schools in the Cook Islands

36 months, $129,200

Mrs Amio Ikihele, The University of Auckland

An mHealth approach: Reducing CVD risk among Pacific people living in NZ

36 months, $128,600

Miss Alvina Pauuvale, The University of Auckland

Mobilising adolescents to drive health improvements in the Glen Innes community

36 months, $129,201

Mr Chris Puliuvea, The University of Auckland

Enhancement of T cells for use in adoptive immunotherapy protocols

36 months, $21,650

Pacific Health Research Masters Scholarship

Ms Tumanu Futi, University of Otago

Is elevated cardiac fibrosis in Pacific patients associated with reduced klotho?

12 months, $32,535

Mrs Amy Henry, University of Otago

Staying at home: A qualitative descriptive study on Pacific palliative care

12 months, $31,244

Pacific Knowledge Translation Grant

Mrs Amio Ikihele, Moana Research

Sexting and NZ-born Niuean adolescent females

6 months, $5,000

Pacific Health Research Summer Studentship

Miss Toni Anitelea, University of Otago

The immunogenetics of Rheumatic Fever and rheumatic heart disease

3 months, $5,000

Mr Adam Faatoese, University of Otago

The applicability of ctDNA as a tool for early cancer detection

3 months, $5,000

Ms Bridie Laing, University of Otago

What are the reformulation preferences of children and young people receiving regular BPG injections?

3 months, $5,000

Miss Meleseini Manukia, The University of Auckland

Vitamin and mineral supplements among Pacific People

3 months, $5,000

Miss Leueta Mulipola, The University of Auckland

Redefining the social construct of depression through Samoan views

3 months, $5,000

Miss Oprah Pupi, University of Otago

The anti-cancer properties of traditional remedies

3 months, $5,000

Mrs Miriam Sundborn, Auckland University of Technology

Can health promotion programmes in schools reduce dental caries

3 months, $5,000

Miss Fuakava Tanginoa, University of Otago

Kids’Cam

3 months, $5,000

Mr Fati Tapu, Massey University

Compilation of Pacific Social Work Resource

3 months, $5,000

Mr Jordan Taylor, University of Otago

Longitudinal quantification of unique Escherichia coli strains

3 months, $5,000

Miss Machaela Tepai, The University of Auckland

Systematic review and clinical audit on non-communicable diseases in Rarotonga

3 months, $5,000