Tomorrow's Medicine Today Edition 2

Northern Sydney Local Health District TOMORROW’S MEDICINE TODAY World-leading clinical trials at Northern Sydney Local Health District

Edition 2

Northern Sydney Local Health District (NSLHD) has a thriving research environment with clinical investigators leading impactful research and clinical trials across all campuses. We are involved in a broad range of work, from large multicentre national and international trials to smaller, practice-changing studies. Each year hundreds of patients join our trials, driving advances in new treatments, devices and medications. Embedding clinical trials into routine clinical care boosts long-term outcomes for patients.

1,272 publications resulting from NSLHD research in 2025

1,200+ participants currently enrolled in clinical trials

20 staff enrolled through the Graduate Certificate of Clinical Trial Operations at Macquarie University (2024 and 2025)

982 active research studies, including 250 clinical trials

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Building momentum Across Northern Sydney Local Health District (NSLHD), we have a strong commitment to delivering the most advanced care possible. Clinical trials and research play a vital role in achieving this goal.

Day in, day out, our world leading clinicians seek better ways to diagnose, treat and care for patients. From multicentre national and international trials to smaller investigations, our staff are always looking for ways to bring better outcomes. Much is happening as we grow our clinical trial and research work. Our expanding trial activity is fuelling strong momentum across the district, including through the development of new therapies, new workforce initiatives and new partnerships. This issue of Tomorrow’s Medicine Today highlights the diversity of work underway across the district. From a pioneering cancer trial using immunotherapy to new research into caring for premature babies and an app to help people with lung disease, NSLHD clinicians are delivering innovations that make a real difference. Alongside new treatments, strengthening our clinical trials workforce is a major priority in building the next era of research. We’re creating more permanent roles within our clinical trials workforce and increasing access to professional development, including staff undertaking the Graduate Certificate in Clinical Trial Operations at Macquarie University. Externally, we continue to build incredible partnerships. NORTH STAR VNP, a venture between NSLHD and Memorial Sloan Kettering (MSK) in New York, US, was established in 2024 as a clinical trials research centre and now has 17 active trials underway across a wide range of cancer tumour types. This international collaboration is a major pillar of our cancer research strategy. Ramsay Health, which operates Royal North Shore Private Hospital, is also a key partner in the NORTH STAR venture. Our relationship with the Mid North Coast Local Health District is also evolving as we work towards more joint clinical trial activity. This not only includes training staff but leveraging their expertise in running trials in rural and remote locations, as well as engaging with Aboriginal communities. In terms of infrastructure, we are opening a new cancer Clinical Trials Unit in the Douglas Building at Royal North Shore Hospital. Crucially, the unit will

be running Phase 1 trials, which involve a drug being tested in a small group of people for the first time to find how safe it is, the best dose and any side effects. We are also creating significant opportunities for the next generation of doctors and specialists to learn the latest cancer treatments. NSLHD’s first local fellowship recipient, Dr Nicholas Della Marta, will soon commence a prestigious oncology fellowship at MSK in the United States, focusing on gastrointestinal cancers. Overall, our clinical trials program is entering a period of significant maturity and acceleration. We are building the workforce, strengthening partnerships, expanding clinical expertise, and delivering new infrastructure that will support innovation for years to come. We want to thank all staff involved in researching and running clinical trials. Your dedication, commitment, leadership, collaboration and focus, sometimes over many years, changes patients’ lives in extraordinary ways. Adjunct Professor Anthony M. Schembri AM Chief Executive NSLHD Nadia Levin Chair of the NSLHD Research, Innovation and Technology Committee May 2026

Moves afoot to prevent bowel cancer

Bowel cancer is the third most common type of cancer in Australia and treating it is both costly and complex. Alarmingly, rates are rising among people aged under 50, and researchers still don’t know why.

Studying polyps Another focus of Mark’s research is improving the follow-up process after a positive screening result. Currently, patients with a positive stool test undergo a colonoscopy, where clinicians look for polyps – small growths in the gut lining that can develop into cancer if not removed. Gastroenterologists and colorectal surgeons remove polyps which are then assessed by pathologists, who examine their size and appearance to determine when the patient should return for a follow-up “surveillance” colonoscopy. But current guidelines as to when this should happen are based on limited evidence and could be improved, Mark says. “Colonoscopies are a massive resourcing problem for the health system and patients can face delays,” he says. To address this, Mark and his team are researching a more personalised way to improve the timing of a colonoscopy for higher risk patients with polyps. Their research involved recruiting patients undergoing a colonoscopy and collecting small biopsies from polyps and nearby healthy gut tissue. These samples were then analysed at a molecular level. “We’ve now identified a number of genes that appear to be linked to higher risk, and this seems to be independent of polyp size” he says.

It is for these reasons that Professor Mark Molloy is on a mission to prevent the disease in the first place. Based in the Kolling Institute and Northern Sydney Local Health District (NSLHD), the leading bowel cancer research specialist is running several projects looking at early detection.

Mark says the first promising pathway is a blood test.

Currently, the main screening method is a government- funded test that detects blood in the stool. The test is mailed to people aged 50-74 years every two years, but Mark says because it requires them to collect the sample themselves, only around 40 per cent return a completed test. “They don’t like handling a stool sample, and early cancers may not leak blood so they can go undetected by this method. So, we’re very interested in whether we can move to a blood test – and not just any blood test,” he says. “We’re working to do this from a few drops of blood collected from a finger prick.” Working with scientists from Sangui Bio, a biotechnology partner of the Kolling Institute, Mark has analysed proteins in blood samples from around 1,200 patients. “We can definitely see a signature in the blood from the finger prick sampling that’s linked to the presence of polyps and early cancers,” he says, adding there is more research to be done.

Tomorrow’s medicine today

Professor Mark Molloy

The science is still unfolding, but

Mark’s direction is clear: user-friendly screening, targeted follow-up, and a deeper genetic understanding of what drives this deadly cancer.

Following publication of this finding, the team is conducting a follow-on study to confirm whether these gene mutations predict future polyp development. If successful, the research could lead to a test that helps prioritise patients for follow-up colonoscopies based on molecular risk – allowing those patients with the highest risk to be seen more quickly than current guidelines dictate. It is estimated 15,000 Australians are diagnosed with bowel cancer each year. “If you vox-popped people in the street, a lot of people would be touched by bowel cancer in some way – if not directly, they would know of someone in their circle,” says Mark.

He says it is unclear why bowel cancer is on the rise, particularly among younger people. “Ideas include changing nutrition over time causing changes in our gut microbiome that are known now to be facilitators of some bowel cancers. Then there’s thoughts about the environment – like the abundance of microplastics that we breathe in and consume. Or it could be our more sedentary lifestyle.”

He says research is ongoing but there is no agreed-upon evidence.

The science is still unfolding, but Mark’s direction is clear: user-friendly screening, targeted follow-up, and a deeper genetic understanding of what drives this deadly cancer. His various avenues of research will hopefully find more answers and help redefine the future of bowel cancer prevention and care.

Tackling the mystery of why some patients’ blood doesn’t clot

When someone is severely injured, the body’s normal response is for the blood to clot and stop the bleeding – it’s a basic survival mechanism. But for reasons that are still not fully understood, some patients with major trauma don’t clot properly.

According to Royal North Shore Hospital (RNSH) trauma specialist Professor Brian Burns, this happens far more often than people realise, affecting up to 25 per cent of patients with severe injuries. “It makes no biological sense,” he says. “From an evolutionary point of view, if you were mauled by a sabre-toothed tiger, your body’s job was simple: run away and clot fast in the area injured so you didn’t bleed to death. But in some severely injured patients, the opposite happens. The clot doesn’t form properly and it also breaks down quickly.” As Brian explains, the key drivers in causing the problem are severe tissue injury and shock, which can cause fibrinogen to break down rapidly and for its levels to fall. Fibrinogen is a key part of clotting – it acts like the cement in a blood clot, holding the platelet ‘bricks’ together so the body can plug the hole.

In some patients, the fibrinogen breaks down within minutes of severe injury. The condition, known as acute traumatic coagulopathy (ATC), increases a major trauma patient’s risk of death four-fold. And because bleeding is the most preventable cause of death in trauma, understanding and addressing ATC is critical. Landmark study underway Finding the best way to identify and rapidly treat this problem is at the heart of a landmark study involving 900 severely injured patients presenting at hospitals across Australia and New Zealand. RNSH is the largest recruiting hospital for the study in NSW and Brian is part of a large investigation team. The trial, called the Fibrinogen Early in Severe Trauma (FEISTY II) study, seeks to compare two different blood products that contain fibrinogen: a fast-mixing powder called fibrinogen concentrate versus cryoprecipitate, which is frozen and takes around 15 minutes to thaw. Aside from the scale of the trial, Brian says the research is also significant as trauma research has historically lagged behind other fields such as cardiology and oncology, partly because trauma patients are so diverse. “They can be quite a hard group to study scientifically,” he says.

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FEISTY Junior will perform the same trial, except in children aged 3 months to 18 years. There are currently no published studies comparing fibrinogen concentrate and cryoprecipitate in the paediatric population. While the FEISTY study is focused on the best way to treat the condition, Brian is optimistic that a sub-study into why some people develop this counterintuitive clotting problem immediately after injury will be done down the track.

“People have this condition and we need to understand why and who’s at risk, so we can pick it up early and manage this clotting problem before it becomes critical,” he says. But for now, by focusing on a clearly defined clotting disorder in trauma cases, the study aims to generate evidence that could reshape care worldwide.

“People have this condition and we need to understand why and

who’s at risk, so we can pick it up early and manage this clotting problem before it becomes critical.”

Professor Brian Burns

The innovative research helping premature babies beat the odds

Each month, clinical staff at the Neonatal Intensive Care Unit (NICU) at Royal North Shore Hospital meet to share updates on their quality improvement projects and possible new areas to advance.

At the Clinical Practice Improvement Club or “CPI Club” as it is known, junior and senior nurses and medical staff are encouraged to develop and lead grassroots projects that help improve care for premature babies on the ward. Department Head and Neonatology Specialist, Dr Eveline Straub, says the club highlights how crucial research is at every level – from small investigations on the ward to multicentre national and international trials. “It’s not just big trial results that we implement but also observations made by nursing staff,” she says.

Where infant survival at 24 weeks was once remarkable, today babies born at 22 or 23 weeks are increasingly beating the odds, thanks to decades of research and clinical innovation. Eveline says that aside from the monthly club meeting, the unit consistently has three or four clinical trials running, alongside investigator-led studies. One international multicentre trial is testing a new method of giving a preterm baby surfactant, a natural lung lubricant that is missing when they are born at less than 34 weeks.

The NICU research team: Dr Eveline Straub, Emily Harrison and Joanne Parker

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Currently, treatment includes inserting a very small tube, squirting the medication into their lungs and then removing it. As part of the trial, clinicians are instead administering surfactant using a small mask that is like a soft scoop that the baby sucks on. It is less invasive and easier to use. “We’re comparing these two methods.” Another international multicentre trial is trying to fix a problem for tiny preterm babies in which a blood vessel close to the heart fails to close and causes cardiovascular problems. Medication that can close the vessel includes using paracetamol and ibuprofen individually, but they don’t always work. “This trial will try both of them together,” says Eveline. She says it is important to contribute to international research, even if the ward only studies 20 or 25 patients. “If we all contribute around the world, we will have a much bigger group and will be more certain that the results we are seeing are true.” Another international multicentre trial involving very premature babies aims to compare different levels of humidification in their cribs. This study is examining how different temperatures could impact skin injury, infection and brain injury. Eveline says that when she began her training in 2002, clinicians were unsure about resuscitating babies at 24 weeks, whereas they are now looking after babies at 22 weeks with a survival rate of around 60 to 70 per cent. “As we push that boundary down, we are getting more and more immature babies, so we need to fine- tune the technology that we use to look after them, and we think that potentially using higher humidity is better for them,” she says. However, there are challenges – more warmth and moisture fosters bacterial growth, and the condensation inside the incubator means you can’t see the baby. “There are many practical aspects that we need to figure out.” Research in neonatal care is an ethically complex area. However, Eveline says for most trials, there is an 80 per cent to 90 per cent consent rate. “When parents arrive here with their baby, I think it becomes very obvious that we are such a technical specialty, and we need to do research to push this ahead. Many know that had their baby been born 20 years ago, they wouldn’t survive, but now they do because we’ve done the research before.”

The monthly “CPI Club” where staff meet to discuss grassroots innovation in care.

She says the field needs long-term research to determine whether an intervention is a good idea or not. “What often seems to be a good idea in the short term might be a terribly bad idea in the long term,” she says. For Eveline and her team, the message is clear: progress in neonatology depends on steady, collaborative research. Each study, no matter how small, adds to the evidence that shapes care for the most vulnerable patients. As Eveline puts it: “Babies need research”. How neonatal research is making a difference As much as oxygen is a good thing for babies, valuable neonatal research has revealed that occasionally it can be toxic. The American singer and songwriter Stevie Wonder was born six weeks premature in 1950, and lost his sight from having too much oxygen in his incubator, which damaged his retinas. The condition is known as Retinopathy of Prematurity (ROP), a disease where retinal blood vessels develop abnormally. “We now know we need to limit the amount of oxygen we give babies – enough for them to breathe but not too much because the eyes could get damaged,” says Eveline.

New approaches in the treatment of alcohol dependency

It is estimated that around one in three Australians drink alcohol at levels considered harmful.

But despite how common alcohol related disorders are – particularly in the Northern Sydney area, where data shows more people use alcohol compared to other drugs – treatment choices are still limited. This gap has driven the Northern Sydney Local Health District Drug and Alcohol Services (DAS) Research Unit – overseen by Clinical Director and Associate Professor Mark Montebello and Research Lead Dr Lauren Monds – to prioritise clinical trials that explore new therapies and seek to improve outcomes. “If you look at antidepressants, there are about 30 to choose from,” Mark says. “In alcohol dependence treatment, we have only three approved mediations.” In 2024, Mark and the DAS team conducted a landmark NHMRC-funded study (led by Chief Investigators Professors Kirsten Morley and Paul Haber, University of Sydney) involving the “gold standard” medication naltrexone, one of the few approved medications for alcohol dependence in Australia. People with alcohol dependence often have a high tolerance for drinking alcohol or experience withdrawal symptoms when they stop. Naltrexone helps reduce the rewarding effects of drinking by blocking opioid receptors and can help lessen cravings and reduce relapse to drinking. It is usually used alongside counselling or other support rather than as a standalone treatment.

In the 12- week trial, NSLHD patients with severe alcohol dependence were given either naltrexone or topiramate – a medication originally used to prevent seizures that has also been shown to reduce alcohol cravings. While earlier trials had shown topiramate to be more effective than a placebo, Mark and his research team wanted to see how it stacked up against naltrexone. The results were striking: topiramate performed remarkably well. “We weren’t the first to discover it,” says Mark, “but we were the first to do it locally in a rigorous way, head-to-head with the gold standard [medication].” Their upcoming trial involves using cannabidiol (CBD), a medicinal cannabis product, to treat alcohol dependence. The study builds on earlier work showing CBD’s potential to reduce cravings in cannabis use disorder. “There’s evidence it decreases alcohol use as well. We’re looking at whether it can be part of the package of treatments we offer.” The service takes a holistic approach to treatment. “It’s not just about: ‘here take this medication’. It’s also what else can we do to help that person with associated issues such as mental health concerns,” he says. According to Mark, the ability to recruit people to alcohol dependence clinical trials has become one of Northern Sydney’s key research strengths. With more patients presenting with alcohol related issues than drug related ones – and many willing to take part in studies – the service has quickly built a reputation as a leading site for alcohol research.

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Stigma is a major barrier to drug and alcohol research and treatment. Even though there are treatments that can help people, only 10 per cent of Australians with

“Over the past eight years, we’ve gone from conducting one or two local studies to being central to alcohol dependence research in Australia,” he says. Research into new treatments is not just important— it is essential. “We’ve got to be doing better than what we’re doing now,” says Mark. “And research is the way forward.”

alcohol dependence ever see a specialist. “The numbers are so low,” says Mark.

There are multiple reasons for this, including the strong drinking culture in Australia and social pressure to join in. He says the shame around admitting an alcohol problem is already significant, and it’s even more pronounced for drug problems. “Everybody knows someone with a drug or alcohol issue,” he says, “but there’s still misunderstanding, and these topics are not openly discussed.” Despite these challenges, Mark is optimistic about the future of drug and alcohol research. The NSLHD DAS has joined major research collaborations and is leading trials that could reshape treatment options.

“It’s not just about: ‘here take

this medication’. It’s also what else can we do to help that person with associated issues such as mental health concerns.”

Associate Professor Mark Montebello and Dr Lauren Monds

A breakthrough era for blood cancer treatment For decades, cancer treatment has generally involved surgery, radiation and chemotherapy. Today, a new approach reshaping the landscape is immunotherapy, which harnesses a patient’s own immune system to attack the cancer.

CAR T-cell therapy and research at RNSH Although CAR T-cell therapy is readily available in the US, it is still a specialised area in Australia, and available in only a handful of public hospitals. Six patients with conditions including lymphoma and myeloma have received the therapy through two clinical trials run with pharmaceutical companies at RNSH’s Haematology Department. Alongside the trials, Cameron is also busy researching in the laboratory, focusing on further engineering CAR T-cells to make them function better. Whereas some tumours are susceptible to a T-cell attack, others have mechanisms that resist it. “The next challenge is to create cells with additional modification so they can function better in the hostile cancer environment,” he says. “We need a new generation or new iteration of CAR T-cells.”

Clinicians use immunotherapy in many ways, but one of the most transformative for certain blood cancers involves engineering a patient’s T-cells – a type of white blood cell – to seek out and destroy cancer cells. Known as CAR T-cell immunotherapy, it was first approved in the United States (US) in 2017 and has expanded rapidly across the world. Northern Sydney Local Health District’s (NSLHD’s) ability to deliver this therapy has taken a major leap forward since 2025, guided by haematologist Professor Cameron Turtle. After nearly two decades at the acclaimed Fred Hutchinson Cancer Centre in the US, where he focused on developing CAR T-cell technologies, Cameron has returned to his old training ground at Royal North Shore Hospital (RNSH), bringing the expertise needed to make this treatment available in the district for the first time. What are CAR T-cells? CAR T-cells are T-cells that have been taken from a patient and genetically modified so they can produce chimeric antigen receptors, or CARs. These receptors act like “guidance systems”, helping the T-cells to recognise a specific protein found on cancer cells. When a CAR T-cell encounters the protein, it latches onto it, becomes activated, and launches an immune attack to destroy the cancer cell.

Cameron says CAR T-cell treatment has brought about a dramatic increase in survival outcomes in patients with some blood cancers. In the past, patients with certain types of lymphomas that did not respond to chemotherapy or transplants unfortunately died. But with CAR T-cells, clinicians are seeing durable remissions for about 40 per cent of patients. “It’s a huge leap from the previous standard of care,” Cameron says. “This therapy has changed the landscape for people who have relapsed, and

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Professor Cameron Turtle

Plans are now afoot to expand the new Cancer Cellular Immunotherapy Service at RNSH. “We need to take the good results we get with CAR T-cells on some blood cancers and extend those to other blood cancers and solid tumours. There is also potential to use CAR T-cells in other non-cancer diseases, in particular autoimmune diseases,” Cameron says. “We have had great results with the first iteration of CAR T-cell products, which have regulatory approval and are now available. But now the effort is in doing research to try to improve how we engineer these cells and make them cheaper, easier to give, and much more effective.” Cameron says it is important to make sure that patients who need approved CAR T-cells can get them.

“From here, we can look to the future with research pipelines and developing new products,” Cameron says. “Now is the time to be putting support into research, because it’ll pay back in spades.”

the usual treatments didn’t work. These genetically modified CAR T-cells are now a standard part of treatment for a number of different blood cancers.” While outcomes are improving, Cameron says there are still downsides to the treatment. “We’ve got a lot of work to do to try to improve the ease of delivery of these products, how expensive they are to make and what sort of side effects people have,” he says.

Exploring the benefits of family therapy for young people in crisis

Over her 30-year career as a clinical social worker – almost 20 of those with the Child Youth Mental Health Service (CYMHS) at Northern Sydney Local Health District (NSLHD) – Dr Di Simes had seen youth suicide rates initially stabilise.

But in recent years, those rates have begun to rise, particularly among girls and younger children. Concerned, Di turned to research on what makes a difference in tackling what is tragically the leading cause of death for children and young people aged 5-24 years in Australia. While no single treatment stood out as clearly superior, studies highlighted several key factors for effective intervention: involving family and caregivers; beginning fairly intense therapy early; focusing on coping skills to improve safety; building strong engagement; and strengthening the caregiver-youth relationship.

Di’s research formed the basis of a PhD in psychology at the Queensland University of Technology under the supervision of Professor Ian Shochet, a leading expert in adolescent depression research. Through interviews with seven different “trios”, Di made several key findings. Individual and family therapy benefits Firstly, she found clear benefits to including parents in their children’s treatment – through individual sessions for both youth and parents, as well as joint therapy. “The research strongly supports moving away from siloed treatment,” says Di. At the beginning of a crisis, “it was very much a picture of fractured relationships with young people feeling isolated in their suicidality and parents basically feeling helpless and also sometimes quite misattuned in how they try to support their child”. Participants felt that the private mental health system promoted an individual therapy model which wasn’t necessarily the best way forward. In one example, she interviewed a 12-year old girl who had been self-harming for four years but had only ever seen a therapist on her own.

“Still, there were lots of knowledge gaps,” she says.

A 2022 review of qualitative research by Di and colleagues identified no research capturing both young people’s and caregivers’ perspectives on what aspects of family based treatment for youth suicidality were helpful or unhelpful. Wanting to fill those gaps, Di led a world-first qualitative study on family-based youth suicide intervention, speaking with 24 participants – young people aged 12-18, their parents, and therapists – about their experience of treatment.

“It actually exacerbated her sense of isolation,” says Di.

“Young people often felt quite connected with their therapist but individually reported that they felt less understood by their parents more isolated. Parents reported consistently feeling shut out.”

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Another key finding was that both young people and parents valued support in improving their relationships. In this – and in another study Di conducted with 35 clinicians – it was common for clinicians to see the young person and parents separately, then together, often acting as a bridge between them before difficult conversations. The clinicians reported benefits in being flexible and tailoring therapies accordingly. “There was no one-size-fits-all in how that was delivered,” she says. Broader implications Di believes the research highlights the broader benefits of family therapy for young people in crisis. She also sees that there is, at times, too much emphasis on individualised therapy. “I think what happens is that people are caught up with a notion of really trying to empower kids and keep things confidential without recognising that at times anxiety and shame may be driving their requests for privacy,” she says. “Obviously, kids’ privacy is to be respected but you’re not really doing them any favours if they’re keeping secret that they want to die or that they feel terrible about their body and they’ve been starving or hurting themselves.” She says young people often avoid telling their families about their struggles because they feel ashamed, worthless, or anxious about being judged. Parents, understandably worried, subsequently increase supervision, which the young person can see as being punitive instead of feeling supported or understood.

Suicide is the leading cause of death for children and young people aged 5-24 years in Australia.

Treatment that includes separate youth, parent, and joint sessions enables these worries to be talked through so that young people receive the help they need and parents feel more confident in supporting their child. While NSLHD is already using similar therapeutic approaches known as attachment based family therapy and adolescent and family dialectical behaviour therapy, Di says the study offers nuanced insights on how to tailor these treatments. “If you actually have a conversation together, you can work through the dilemmas,” she says.

Dr Di Simes

New strategy promotes research for all Research is not the responsibility of a select few; it is a shared endeavour and an opportunity for everyone. The Northern Sydney Local Health District’s (NSLHD’s) new research strategy outlines an ambitious vision to embed a culture of research at the heart of our organisation, making it an integral part of everyday practice across our workforce.

Our new strategy has been shaped over 12 months through extensive engagement with more than 300 stakeholders from across NSLHD and beyond. Their collective insights have informed an approach that is practical, inclusive, and forward looking, capturing the shared aspirations of our workforce and partners.

At the core is an inclusive approach, making sure our research is designed to address the needs of underserved and priority populations. To do this, we encourage co-designed research, equity of access to participation in research, and better use of technology and data systems. A generous $20 million gift from Greg and Kay Van Norton Poche has enabled us to move faster in building our research capability. It is supporting the establishment of a world class cancer clinical trials centre and will strengthen research across all clinical areas. In recognition of this momentum and vision, our directorate will be known as North Sydney Trials and Research (NORTH STAR), a name that reflects leadership, innovation, and excellence in clinical research.

Above all, this strategy is a call to action to think differently, work collaboratively, and make research part of how we deliver care every day. Together, we can transform health services and improve outcomes for all.

Professor Naomi Hammond Northern Sydney Local Health District Executive Director

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Kolling at the centre of life-changing health research As research capabilities expand across northern Sydney, that growth will be supported by the expertise and experience at the Kolling Institute.

Located next to Royal North Shore Hospital, the Kolling has been at the forefront of scientific discovery for more than 100 years. It is the oldest health research institute in the state, and home to Australia’s first diabetic clinic. Today, researchers are pursuing innovations from discovery science to impactful, potentially life-changing projects. Their work is extending our understanding of complex health conditions, offering new treatments and improving community wellbeing at every age. At the Kolling Institute, investigators consistently produce world-leading research into some of our most significant health challenges, including heart and kidney disease, chronic pain and neurological conditions, as well as cancer, musculoskeletal and age-related conditions. Current research projects are set to help transform care for knee osteoarthritis, rare cancers, pain and diabetes, while others are shedding light on the genetic factors driving heart disease and disabling Meniere’s disease. A large share of investigators are ranked in the top two per cent of global experts in their field; remarkably, this is not limited to a few research areas, but reaches right across the institute. The depth of experience places the institute in a privileged position. It is an important year for the Kolling, as it launches its refreshed research strategy, delivering a robust strategic framework for the next five years. This will ensure researchers are in the best position to progress their crucial work, and extend access to the very latest, high-value care. The forward-looking strategy comes after many months of work behind the scenes, with input from researchers, clinicians, and scientists as well as patients and those with lived experience, administrators and industry partners. A key part of the strategic direction will see cancer established as a focused area of research. The Kolling will draw on its strength in this field to foster innovative research that improves cancer

treatments, survival and outcomes, not just across our district but nationally and worldwide. Our research success relies on our strong partnerships, and the refreshed strategy will increase efforts to expand local, national and international collaborations. Community input and engagement will be another crucial part of our research impact. As a joint venture partnership, the Kolling Institute is supported by the resources and expertise of the University of Sydney and the Northern Sydney Local Health District. This places investigators in a strong position to drive significant change in the delivery of healthcare. Researchers are well placed to maximise the impact of their work given the combined efforts of the local health district, NSW Health, the Kolling and the university. Driven by a shared belief that research is the cornerstone of high-quality healthcare, each organisation is working towards a common goal of sustained research growth and success. Our Kolling Institute researchers are proud to be part of the collaboration, and dedicated to building on their remarkable legacy, offering hope, and better long-term health outcomes.

Professor James Elliott Academic Director The Kolling Institute

Patient commitment powers renal research

Within the busy clinical environment of the Royal North Shore Hospital (RNSH) Renal Clinic, clinical trials manager Rebecca Stevenson looks after a significant research portfolio, with around 20 clinical trials in progress at any time.

“Not only will they actively take a dummy tablet for up to five years but they will come in regularly for their visits, and have extra cardiac scans and blood tests,” she says. “In a very generous way, they help us understand whether this medication could be an effective way to improve quality of life and reduce hospitalisations for millions of patients like them in the future.” Rebecca says she consistently sees this level of patient commitment across other RNSH renal trials. Many of the patients have had kidney disease from a young age; others live with autoimmune kidney disease where their own body attacks the kidneys. “They are generally well informed about their kidney health,” she says. “These patients understand the potential decline in kidney function over time and they’re only too willing to be part of the research.” For example, in another trial, patients with another form of kidney disease called IgA nephropathy are injecting themselves fortnightly under the skin with a medication that may also be a placebo. “They are willing to follow a strict regimen and dose themselves at home in order to help further medical research.” To maximise the reach of these trials, RNSH also collaborates with the George Institute for Global Health on the Renal LifeCycle and other studies.

The studies are diverse and span early recruitment to long-term follow-up. Some are international, sponsored by major pharmaceutical companies, while others are led by RNSH clinicians investigating innovative treatments to improve clinical practice and answer important questions arising directly from patient care. Rebecca says much of the work focuses on finding better ways to slow the decline in kidney function for patients living with chronic kidney disease. “Research is often a long game. While we occasionally see results quickly, more often the outcomes won’t be published for two-to-five years,” she says. But what consistently impresses Rebecca is the extraordinary generosity and altruism of the patients who join the clinical trials. She cites the example of the Renal LifeCycle trial, a large global research project investigating dapagliflozin, a medication known as an SGLT2 inhibitor, which is currently used to treat type 2 diabetes, heart failure and certain stages of chronic kidney disease. SGLT2 inhibitors help the body remove excess sugar through the urine. Although dapagliflozin is already approved for some kidney disease patients, it is not yet available for people on dialysis or those who have received a kidney transplant. The trial, involving more than 1,500 patients worldwide, is examining whether it is safe and effective for these groups of patients. Rebecca says there are currently 22 RNSH patients in the study, some of whom are willing to take a placebo for up to five years.

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The extraordinary commitment of patients and clinicians has put RNSH at the forefront of renal research, generating evidence that is helping to change outcomes for people with kidney disease around the world.

Rebecca Stevenson

Rebecca says many trials are testing different ways of delivering treatments and aim is to give patients more choices and help new medicines reach people in low-and middle-income countries, where kidney disease is common and treatment options are limited. “Oral medications are obviously much easier to transport and deliver to people all around the world rather than injections and having to keep things in the fridge,” she explains. The extraordinary commitment of patients and clinicians has put RNSH at the forefront of renal research, generating evidence that is helping to change outcomes for people with kidney disease around the world. The trials also provide hope to patients.

“I really love the patient contact and the opportunity to offer treatments to patients that are not otherwise available,” says Rebecca.

“There are cases where I’ve seen our patients try new treatments through clinical trials that have since gone on to become approved for public use and have delivered substantial benefits. Seeing those positive outcomes has been incredibly rewarding.”

Most first-time mums focus on their baby’s arrival. But for Alexandra Loftus, giving birth at Royal North Shore Hospital (RNSH) was also a chance to give back – by joining a clinical trial of a new device that monitors babies’ oxygen levels during labour. Breakthrough technology could prove a ‘revolution’ for safer childbirth

“I thought it was a wonderful opportunity for little Poppy to come into the world being part of something bigger,” says Alexandra. “The fact that this device will do more and is much less invasive [than current monitoring] is huge.” Traditionally, babies’ heart rates have been monitored during labour via cardiotocography (CTG), which involves placing a belt with two monitors around the mother’s abdomen.

“The technology has been around for decades, but the problem is it has very little sensitivity and specificity in telling us if the baby is okay or not,” says RNSH Obstetrician and Gynaecologist Dr Sean Seeho. Another method for assessing a baby’s wellbeing during labour is measuring lactate levels – a chemical produced when oxygen is scarce – which Sean called the “gold standard.” The test involves taking a drop of blood from the baby’s head using a device known as an amnioscope. “Basically you do a little nick with a small scalpel on the baby’s head. Just like a diabetic test, instead of measuring sugar, we measure lactate,” he says. However, lactate tests only provide a snapshot of the baby’s condition at the time of sampling and can be an uncomfortable procedure for the mother. The new device, however, is far more efficient. Building on technology known as a fetal scalp electrode (FSE), a small spiral sensor which is attached to some babies’ scalps during labour to measure heart rate, the new device has incorporated a microneedle that detects lactate levels. Shaped like a corkscrew, the sensor gives off an electrical signal when lactate is present. “It doesn’t bleed the baby,” says Sean. The lactate data is then transmitted through a wire to a device worn on the mother’s leg, which then relays the information via Bluetooth to a central monitor.

Alexandra Loftus and Poppy.

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“We always say the day a baby is born is probably one of the most dangerous days of its life,” says Sean.

“For the first time, we will have a sensor that will give us the gold standard of monitoring for the baby’s well-being.”

The research team at RNSH: Dr Sean Seeho, Sharon McCracken, Professor Jonathan Morris and Laura Warby

Between March and August 2025, Alexandra was one of 10 Australian mothers – including five at RNSH – who wore the device, which Sean describes as a “revolution” in the delivery of babies. “I’m so excited. I wish I was 10 years younger in my career,” he says. “Instead of having snapshots of what the lactate is, this machine will continuously read it throughout the whole of labour”. Low oxygen levels during birth can lead to cerebral palsy, a lifelong condition caused by brain injury that costs the Australian economy an estimated $15 billion each year. “This device will certainly reduce those cases, because you’ll be able to better monitor those babies,” he says, adding that the device won’t necessarily be used on all women. VitalTrace, a medical-tech company based in Western Australia, has been developing the device

in collaboration with researchers from the University of Western Australia and the University of Sydney for seven years. Professor Jonathan Morris, an Honorary RNSH Obstetrician and Gynaecologist, is the chief medical officer of the company. Plans are now underway for a further trial and a larger feasibility study. “We always say the day a baby is born is probably one of the most dangerous days of its life,” says Sean. “For the first time, we will have a sensor that will give us the gold standard of monitoring for the baby’s well-being.” For Alexandra, participating in the clinical trial was straightforward, particularly as the device was wearable. But more importantly, she was proud to be part of a potential shift in maternity care, which could benefit her daughter. “I feel quite excited for Poppy’s generation, that they will have something that’s much more seamless” she says.

When Sister Kenny came to RNSH: a clinical trial like no other By Catherine Storey, Honorary Associate Professor from the Northern Clinical School and Honorary Archivist Royal North Shore Hospital Possibly one of the most unusual clinical trials ever undertaken at Royal North Shore Hospital (RNSH) involved an ex-Prime Minister, an unqualified ‘bush nurse’, orthopaedic surgeons and reports tabled in the NSW Parliament.

The philosophy of the clinic, as viewed by the Federal Health Minister in 1935, aligned with the Labour Party’s policy of expanding services for the general public. Hughes was keen to ensure that a clinic be established in NSW, and where better than in his own electorate of North Sydney? By June 1935, Hughes directed the Board of Directors of RNSH to “house a clinic which would be under the direction of Sister Kenny”. The Honorary Medical Staff, in particular the orthopaedic surgeons, were not impressed.

In early 1935, William “Billie” Hughes, then the Federal Minister of Health – who had been Prime Minister during World War I – travelled to Brisbane to witness the famous “Sister Kenny Clinic” first-hand. Sister Elizabeth Kenny, then aged 56, was already well known in Australia, Great Britain and the United States for her unconventional treatment of poliomyelitis (infantile paralysis). Although referred to as ‘Sister’, there is no documented evidence of her having any formal nursing qualifications. Yet, in 1911, she had established herself as a “bush nurse” serving the outback communities of NSW and Queensland and she joined the Army Nursing Service in 1915, serving until 1919. While nursing in the bush, Sister Kenny encountered many young children with acute poliomyelitis, one of the most feared childhood diseases. When orthodox practitioners managed these children with immobilisation, plaster casts and callipers, Sister Kenny advocated for heat, massage and movement. By 1933, she had established a large clinic and training school in Brisbane. The public was fully supportive, and each newspaper article in which the medical orthodoxy denounced her methods was matched by stories of her successes. The public revered her.

Sister Elizabeth Kenny (left)

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At RNSH, the Board fitted out a clinic to Sister Kenny’s precise specifications. Requests for appointments poured in from the local community, across the state and nationally. The Board of Directors, partly to appease the Honorary Medical Staff, requested that the Council of the Institute of Medical Research (IMR), the forerunner of the Kolling Institute, appoint a medical committee to examine a selection of cases from the clinic before and during treatment. The committee would then report its findings to the Board and the NSW Parliament. Dr Wilson Ingram, Director of the IMR, chaired the committee, which consisted of seven medical men, including several orthopaedic surgeons. Sister Kenny agreed to select 25 cases representative of those seen in the clinic. However, she was not prepared to disclose her methods until the committee reported favourably upon her work! The first report was presented to the NSW Parliament on 15 May 1936. The committee examined 25 cases, a mixture of children with polio, acute and chronic, as well as cases of cerebral diplegia (cerebral palsy). A more comprehensive report with detailed individual case studies was published in the Medical Journal of Australia in 1937. The examiners agreed that the clinic was well organised, that there was improvement in muscle strength in all cases of infantile paralysis and in coordination in those with cerebral diplegia. They also found that patients were very optimistic about their treatment. Much of the success, however, the committee attributed to Sister Kenny’s dominant personality. While expressing some regret that the study had not included a ‘control’ group or been conducted over a longer timeframe, the committee concluded that the “Kenny method” involved nothing more than techniques commonly used by trained masseuses (the forerunner of physiotherapists); that Sister Kenny’s methods did not represent a ‘breakthrough’; and that the treatment of these patients belonged “to the sphere of the orthopaedic surgeon”. The committee went further and recommended the building of a 300-bed special orthopaedic hospital. Within the grounds, they envisaged a school, a hostel, occupational therapy workshops and training facilities, and a splint factory! Needless to say, these facilities never eventuated. In 1940, Sister Kenny left Australia for the United States, where she was welcomed as a hero. A full-length Hollywood movie, Sister Kenny , starring

The movie poster for “Sister Kenny”, released in 1946

Rosalind Russell, was released in 1946. (It also screened at RNSH). The Kenny Clinic continued at RNSH in her absence, with generous support from the Federal Government, until 1948, when its accommodation was needed to house the new intake of medical students. Her clinic was finally absorbed into the Orthopaedic Department. Sister Kenny died in Toowoomba in 1952, just a few years short of seeing the introduction of a vaccine for polio, developed by Jonas Salk in 1954 (Australia in 1956), followed by an oral preparation developed by Albert Sabin in 1963. The last polio epidemics in Australia occurred in 1956 and between 1960 and 1962. Australia was officially declared polio-free in 2000. At RNSH, the appraisal of Sister Kenny’s technique involved a most unusual clinical trial. There is little chance that this trial would have progressed through a modern ethics committee!

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