Dr Ruairi Waters

Consultant Stroke Physician at Saolta University Health Care Group

Dr Catriona Reddin

Geriatric Medicine Specialist Registrar, Saolta University Health Care Group and ICAT fellow, University of Galway

Researchers in Ireland are working on increasing access to clinical trials for older people to have targeted healthcare solutions that help maintain their independence as they get older.

Older people are vastly underrepresented in clinical trials despite shouldering a disproportionate burden of chronic health issues. However, a cohort of research doctors in the Institute for Clinical Trials in Galway are working to ensure scientific advances are translated into improved care for older patients.

Addressing unique needs of older people

Dr Robert Murphy from the Saolta University Health Care Group says: “We have a young, vibrant research team, which is tackling problems in older adults with a particular focus on prevention and management of conditions that lead to disability.”

The team aims to find ways to ensure that older adults live long and independently. “Our research is also designed to be inclusive, ensuring that harder-to-reach populations are represented and have equal access to medical support,” he adds.

Structuring healthcare delivery for older people

Prof Michelle Canavan, Professor of Older Adult Health at the University of Galway, believes that involvement in clinical trials, which informs evidence-based care, improves the standard of care for everyone in the region. “Multidisciplinary care is the cornerstone of geriatric medicine and therefore, research in this area involves doctors, nurses, carers and health and social care professionals (physiotherapists, speech and language therapists, social workers, among others) working with the older person themselves,” she says.

Our research is also designed to be inclusive, ensuring that harder-to-reach populations are represented and have equal access to medical support.

Dr Robert Murphy

Providing accessible clinical trials both in hospitals and at community level is key. “Running clinical trials locally is vital, not only in ensuring that older people are represented (particularly those from rural areas) but also to drive innovations in healthcare, which often come from clinical research. The newly launched Institute for Clinical Trials at University of Galway will help advance and accelerate this,” she adds.

Medtech devices to aid care

University of Galway is a Medtech Hub, with an interest in how medical devices can lead to improvements in patient care or diagnosis of common conditions. Dr Ruairi Waters is Co-Principal Investigator on a General Practice based screening trial for atrial fibrillation (AF). AF has a five-fold increase in the risk of stroke. A major care gap in stroke prevention is the prevalence of undetected AF. “Through a clinical trial, we aim to determine if extended cardiac monitoring using external wearable monitors results in increased AF detection in high-risk individuals.”

Dietary supplements for falls

Dr Catriona Reddin is completing a PhD exploring the association between dietary factors and falls; within this, she is gaining training in clinical trials supported by the Institute. “There’s a research gap in the older adult population for the treatment of a common cause of falls, orthostatic hypotension (where blood pressure falls when standing up). Our new clinical research study (STOOD trial) aims to determine if increasing salt intake in older adults with falls is tolerable and effective as treatment for this condition.” With access to trials and innovation in medical products, researchers hope to make dramatic changes in healthcare to improve quality of life and maintain independence for older people.

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Dr Steven Griffin

Manager, Health Innovation Hub Ireland, University of Galway

A health innovation hub is driving Ireland’s healthcare sector by supporting startups in developing new products and devices to improve patient outcomes and help clinicians deliver better care. 

The Health Innovation Hub Ireland (HIHI) was established in 2016 to support the country’s burgeoning healthcare industry. It ensures the best ideas from startup businesses and enterprises reach their full potential. A wide range of products and services have already been developed, with more in the pipeline. 

Matching innovation with expertise 

Its manager, Dr Steven Griffin, says enterprises engage with HIHI via its online innovation portal, with the idea assessed, reviewed and evaluated before companies are matched with relevant expertise. “Once at the prototype stage, the product goes in front of users, prescribers and people with clinical or technical expertise to give critical feedback so that they build the right product for the right people,” he adds. Medical devices and digital systems are also piloted before market release. 

National Director Dr Tanya Mulcahy, says: “Our differentiator is that we are embedded in academic institutions and the healthcare system and are uniquely positioned so that companies can leverage support.” Connecting enterprise and clinical delivery, she emphasises the importance of feedback from clinical end users at an early stage to ensure product development proceeds in the right direction. 

A product idea should be useful to the
healthcare system and address a real problem.

Ideas addressing clinical needs 

A product idea should be useful to the healthcare system and address a real problem — whether in primary care, an acute hospital or diagnostically. “Our job is to ‘triage’ the perceived good ideas, prototypes and products and pick ones we know are going to be successful and address a need,” Mulcahy says. For instance, its FemTech programme brings together innovators in women’s health for products and services to address what has been an under-served area for investment and research.  

Supporting jobs and global health  

Among other innovations, that process has seen interventional radiologists test devices; development of patient apps; and surgical innovations within the orthopaedic sector. “The health technology sector is an important economic element for Ireland by supporting thousands of jobs, and we are enabling small companies to fast-track development of their products and become successful,” insists Mulcahy. “From an Ireland point of view, we hope they will be exported worldwide and be successful and contribute to more and better jobs and health outcomes.” 

HIHI, a national entity seated in universities in Cork, Galway and Dublin, has recently launched the Clinical Innovation Award for healthcare staff who have an early-stage idea to apply for 15,000 euros to explore market opportunities. 

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Professor Aoife Lowery

Consultant Surgeon and Clinical Lead for the Clinical Research Facility,
University of Galway

Dr Alanna Stanley

Lecturer in Anatomy and Radiology, University of Galway

A bench to bedside approach pioneers collaborative solutions, advancing research to meet patient needs.

Patient-focused research involves clinicians working with researchers to solve unmet patient needs — from reducing drug side effects to developing medical devices that help patients lead more comfortable lives during and after treatment.

Trials accounting for lived experiences

University of Galway’s Institute for Clinical Trials runs ‘Bench-to-Bedside’ research, which takes stock of what patients feel they really need.

Aoife Lowery, Professor and Consultant Surgeon at University of Galway, focuses on clinical trials, which sit between conception and delivery. “Patient engagement is a critical element of the clinical research process. We work with patients as research partners and value their experience and perspective when investigating a research question and designing a clinical study to validate the pre-clinical findings of the scientists and bioengineers.

An example of a patient-led conception was reducing post-operative side effects such as pain for lung cancer treatment. “Patients often say they feel worse six months post-surgery than they did before,” explains Professor Martin O’Halloran, a bioengineer on the programme. “As a result, we are beginning trials on minimally invasive lung cancer treatment.”

Scientists at University of Galway regularly talk to clinicians and patients as part of the process when validating an unmet need. That means they understand their needs and are motivated to come up with solutions.

Professor Aoife Lowrey

Studying the human body

Dr Alanna Stanley, Lecturer in Anatomy, University of Galway, says: “Through anatomical research, we can improve our understanding of the human body, enabling us to better interpret results from our pre-clinical models. For instance, in the Anatomy Imaging and Microscopy facility, we carry out advanced analysis on the interaction of medical technologies and device with cells and tissues,” she explains. 

Professor O’Halloran’s team worked with Dr Stanley to develop a device to reduce the side effects of chemotherapy. “There has been an under-emphasis on the trauma and pain of hair loss,” he says. “Patients and their families are very affected by this. We developed a technology that reduces blood supply to hair follicles, to reduce this side effect.”

Quickly developing solutions

The Bench-to-Bedside approach focuses on translating science for patient benefit. “Scientists at University of Galway regularly talk to clinicians and patients as part of the process when validating an unmet need. That means they understand their needs and are motivated to come up with solutions,” explains Professor Lowery. Moreover, having clinicians, scientists and bioengineers under one roof means change can happen more quickly. “We had the idea for one of the breast cancer technologies in November. By March, we had started a patient study, which is extraordinarily quick,” says Professor O’Halloran.

“Harnessing the immense potential of collaborative patient-focused research, the Institute for Clinical Trials promises to drive innovation and deliver on cutting-edge clinical trials that are regionally relevant and globally impactful,” says Professor Lowery.

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The Young Adult Panel (YAP) are taking the lead in a study to transform type 1 diabetes management and support.

Type 1 diabetes is a chronic condition in which the pancreas makes little or no insulin. Insulin is a hormone, which allows sugar (glucose) to enter cells to produce energy. The psychological and physical challenges can be exhausting, particularly as young adults try to enjoy a full life.

Lack of support for young adults with diabetes

Dr Eimear Morrissey, Postdoctoral Researcher at University of Galway, says: “Young adult diabetes services do not meet the needs of many young people. For example, each time they attend clinics, they may meet different doctors and have to tell their story anew.” A study called ‘D1 Now’ wants to reimagine how diabetes care is delivered to young people.

Young adults seeking change

Síofra Kelleher, aged 23, is one of the eight YAP members in the D1 Now study. She was diagnosed with type 1 diabetes at age 10. As complications increased, she joined patient studies but felt like she was ‘just a number.’ “However, I found the panel. This enabled me to become an advocate, including taking part in international conferences and patient advocacy.”

I wanted to try and take control of my situation by helping to make change.

Lydia Dodd

Cameron Keighron has been a member for nine years. After being diagnosed at 16, they said: “I was put in adult services straight away. Their attitude was, ‘You are an adult and should know how to manage your condition,’ but I only just got diagnosed.”

Complaints of information gaps are typical, including how to live with diabetes with a desire for sport, studying and work. That feeling of not being understood runs deep, according to Kelleher. “I know someone who doesn’t attend a clinic; with overcrowding and low staff numbers, if you miss an appointment, you could be put back on a waiting list for years.”

Novel idea receives trial funding

Lydia Dodd, diagnosed at 22 years old, says: “I wanted to try and take control of my situation by helping to make change.” So, Dodd joined the YAP to support the research. Together, the panellists are considered ‘co-researchers’ and provide input into each stage of the study, including sitting on interview boards and designing questionnaires.

D1 Now has been awarded €1.2 million from the Health Research Board for a randomised study at 12 clinics across Ireland. Dr Morrissey adds: “D1 Now has emerged as a catalyst for change. This study has empowered young adults by allowing them to act as co-researchers and reimagine diabetes care delivery, to reshape the entire experience and enhance patient support. We hope that other services will learn from this experience.”

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Olivia Lane

HSE Ambulance Service and ICU Patient Representative

Dr Bairbre McNicholas

Consultant Intensivist, Saolta University Health Care Group and Senior Lecturer, University of Galway

Studies at the Institute for Clinical Trials aiming to regulate blood pressure of patients with sepsis, are navigating ethical guidelines to advance medical treatment.

Studies to improve patient outcomes for sepsis require a delicate balance between explaining the possible risks and the benefits of clinical trial participation — often with loved ones under acute time pressure in ICU wards.

Intensive care challenges

“Clinical research ensures we can discover what the best current treatments are and how we can safely explore improvements in what we do,” says John Laffey, Professor of Anaesthesia and Intensive Care Medicine at the University of Galway. Co-convening a study to reduce the risk of low blood pressure during the management of patients with invasive mechanical ventilation, he aims to find a drug administration strategy that can maintain normal blood pressure.

“Our area of research is acute — it happens fast, so treatments must be given in the earliest phases of the illness. Patients may be temporarily incapacitated due to the severity of their illness, and so are unable, at that point, to give consent to participate in research.

Considering patients with lived experiences in ICU is a huge part of making the ethical case for participating in clinical trials while deferring patient consent.

“Research is essential to advance treatments for critical illnesses … If the next of kin gives assent on behalf of the patient, we can then enrol the patient in the study. When the patient’s condition improves, we can engage with them directly.” He adds that once patients can give consent, they make the ultimate decision and can withdraw if they wish.

Role of patient groups

Considering patients with lived experiences in ICU is a huge part of making the ethical case for participating in clinical trials while deferring patient consent until they are able to decide for themselves.

“I was a critically ill patient with sepsis and found out a few weeks later that I was paralysed. I believe that every study can help the next patient to get a better outcome,” says Olivia Lane, an ICU survivor and patient representative.

Randomised trial of blood pressure targets in sepsis

Dr Bairbre McNicholas, Senior Lecturer at the University of Galway is co-convening a study, to determine the optimal blood pressure for patients with sepsis. “We know higher blood pressure affects sepsis treatment. Using their previous blood pressure readings to determine their target during septic shock may improve outcomes. It’s a randomised trial, comparing this to current approaches, so if someone signs up, they will either receive normal care to the utmost level or they will get the more detailed evaluation of appropriate blood pressure levels.”

Professor Laffey concludes: “We find that next of kin are more conservative about taking part in trials than patients. However … they realise it’s the only way to help move science forward.”

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Professor Seán Hynes

Professor in Pathology, University of Galway

Biobanks store medical samples from donor patients. They play a pivotal role in advancing clinical research in oncology and many other diseases.

To better understand the underlying molecular processes of cancer, cardiovascular, infectious, metabolic and other chronic diseases, researchers need to analyse samples from patients. Biobanks are repositories of meticulously collected and preserved patient specimens, including tissues, blood and genetic material. They serve as invaluable resources for scientists and clinicians.  

Safe and confidential preservation in biobanks 

Biobanks enable the study of diverse challenges and aid in the development of targeted therapies, personalised medicine and early detection, which can speed up research. This is translational research in action.  

Remembering the patient behind every sample 

Anyone who donates to a biobank is made aware that, while they will not benefit directly from this research (samples are anonymised to protect patient confidentiality), their involvement can contribute to medical advances. “We never forget that behind every sample is a patient,” says Professor Seán Hynes, Professor in Pathology at the University of Galway. “When someone voluntarily consents to giving samples and data to our biobank, they are performing a massively valuable and selfless act.” 

We never forget that behind
every sample is a patient.

Professor Seán Hynes

Naturally, good leadership is vital for a biobank to operate efficiently. Dr Nicola Miller, Co-Director of the Cancer Biobank led from the University of Galway says: “Our commitment to quality builds trust among researchers, collaborators, funders, regulators and especially participants. We care deeply about patient engagement, and we ensure that participants know exactly what they are contributing to and why the work of the cancer biobank is so important. Better engagement means better samples and, ultimately, better research leading to treatment and cures.” 

“Our cancer biobank supports the validation of experimental findings and accelerates the translation of lab discoveries into clinical applications — not only here in the Institute for Clinical Trials at University of Galway but as part of ongoing research throughout Europe. In essence, cancer biobanks are indispensable tools in the fight against cancer and other diseases, fostering innovation and directly improving patient outcomes.” 

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John MacNamara

VP of Research and Development, Medtronic and
Chairperson of the BioInnovate Ireland’s Advisory Board

Garrett Murray

Head of Life Sciences Sector, Enterprise Ireland

As a global leader in medical technology (medtech), Ireland is looking to fund the most talented people from around the world to develop innovative solutions that match the needs of clinicians and patients worldwide.

Ireland hosts approximately 450 medical device companies and 200 digital health companies; the majority of which originate in Ireland itself. “Ireland is recognised internationally as a global medtech hub. This success is demonstrated by the international competitiveness of our high potential startups (HPSUs), established Irish companies and the presence of global companies in the sector in Ireland,” says Garrett Murray, Head of Life Sciences, Enterprise Ireland. This makes it an ideal place to develop a talent pool equipped to address evolving healthcare challenges through innovation in device development. 

Fellowship programme for medtech innovators 

Professor Martin O’Halloran is Executive Director of BioInnovate Ireland — a medtech and digital health innovation fellowship programme affiliated with Stanford Biodesign. It is situated at the University of Galway and co-funded by Enterprise Ireland. “We recruit 12 really smart, capable people from across the world and give them a year to develop a concept for a new medical device,” explains Professor O’Halloran, who leads the team that provides technical and commercial guidance to fellows.  

He also says the team’s ability to do good work requires support from the medtech ecosystem. The advisory board and mentors are leaders in the Irish medtech sector and support the programme in all activities. “Innovation programmes like BioInnovate provide an effective bridge between clinical needs and the market, which ultimately means a medical device can succeed,” he adds.  

Clinicians calling for startups  

Alongside the fellowship’s team of lecturers and mentors, he has witnessed the legacy of the fellows. “The programme has resulted in 33 startups, 22 of which are defined as HPSUs by Enterprise Ireland… That means one in eight of all Irish medtech companies have come from the programme. That is good for us as it proves that the BioInnovate programme is working. It’s also good for Ireland as we’re embedding innovation and showing why we’re the best place in the world to start a medtech company.” 

John MacNamara, Chairperson of the programme’s advisory board, adds: “There has been an evolution in the past decade — from a position where you had to encourage clinicians to get involved in innovation to an attitude of ‘Can we get your people in our room to find a solution?’” He says this shift is due to the growth of clinical trials in Ireland leading to demand for startups offering viable solutions.  

The programme has been a key driver of success
by bringing a diverse group of actors together
to commercialise research and innovation.

Garrett Murray

Connected health and instant data 

Global healthcare is moving towards connected health, remote monitoring, smart devices and the use of data to improve patient care. The fellowship programme actively supports teams to realise opportunities and address the challenges of developing connected healthcare solutions.  

“As the medical device sector becomes more digital, our programme has recruited more people with a digital health background,” explains Professor O’Halloran. MacNamara says fellows can help create the technology to meet the demand for insight-driven care. “We are looking for more candidates who can create the medtech to support clinicians with real-time decision-making,” he says. “Physicians want devices that bring back data intra and post-procedure.”

“For example, gastrointestinal surgeons use scopes to look for disease. However, using machine learning, they can make assessments based on detailed images. This adds to the efficacy of the procedure by automating it in a better way.”  

Developing solutions based on needs 

Searching globally for the next, big digital health innovator is a key part of the fellowship’s remit. Around 100–200 people apply, with 30 being assessed before a select dozen are offered a fellowship. It also runs part-time industry programmes to embed innovation in existing medtech companies in Ireland.  

“The programme has been a key driver of success by bringing a diverse group of actors together to commercialise research and innovation, underpinning startup formation and improving patient outcomes globally,” adds Murray.  

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A research team is conducting a study to examine whether the human body’s cannabis-like signalling molecules could lead to advances in back pain treatments.

With a quarter of visits to GPs in Ireland being for back pain, the condition is a huge burden for sufferers and health providers. Moreover, treatment options are still not consistently effective, according to researchers.

Exploring endocannabinoids for back pain 

A team connected to the Institute for Clinical Trials at the University of Galway is investigating a new option focusing on endocannabinoids — the body’s own cannabis-like signalling molecules — as a potential treatment. The study aims to lead to development of novel endocannabinoid-related biomarkers and therapeutics. 

Principal Investigator David Finn, Professor and Head of Pharmacology and Therapeutics at University of Galway and Co-Director of the institution’s Centre for Pain Research, explains that 650 million people globally currently suffer from back pain, and that could hit 843 million by 2050. “There are multiple reasons why someone can develop back pain,” he continues. “That can be from stress, wear and tear, damage, injury or organic causes including diseases such as cancer.” 

The research focuses on intervertebral
disc injury or degeneration, which accounts
for 25–40% of all low back pain.

Disadvantages of current treatments 

The research focuses on intervertebral disc injury or degeneration, which accounts for 25–40% of all low back pain. Finn says available treatments only work effectively in some patients, and current drugs can have side effects or become addictive, while surgical treatments, like spinal fusion, are not always successful. 

“It is a major unmet clinical need,” he adds. “We need to better understand the condition and the neurobiology of low back pain and be able to better predict, through research, who will transition from acute short-term low back pain — which might last a few days — to chronic back pain, which lasts months or years.” 

What the study hopes to find 

Mary Hopkins, a fourth-year Ph.D. student at University of Galway conducting the research, says: “We know these signalling molecules are involved in pain relief and can be dysregulated in certain types of chronic pain, so the study aims to find out whether endocannabinoids can be potential biomarkers for diagnosis and targets for treatment of this pain.” 

The study, conducted with the Clinical Research Facility and Institute for Clinical Trials at the University, is recruiting patients who have recent acute lower back pain and those with chronic low back pain for more than three months.

It will see if endocannabinoid measures in the patient’s blood correlate with their pain scores, assess if the endocannabinoids can predict who might develop chronic pain — and whether endocannabinoids are viable pharmacological targets when their levels are modulated to achieve pain relief. 

*The research is funded by the Irish Research Council. Anyone interested in the research or participating in the study can contact Mary Hopkins at: m.hopkins9@universityofgalway.ie 

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Mother-of-two Carmel McDonagh, 43, was diagnosed with type 1 diabetes when she was 17. She highlights how important it is to participate in clinical trials.

How did you become involved in clinical trials? 

It was when I thought about having another baby. When you are diabetic and pregnant, it is important to have your sugar levels right. I met Professor Fidelma Dunne, and she said I would be a perfect candidate for the ‘EXPECT’ trial of women with diabetes and pregnancy. It was a randomisation of insulin types to see which was better for women during pregnancy. 

What was the experience like for you? 

I now run two Airbnbs, but I wasn’t working when I was pregnant with my second child, who is now three. I’d go to the clinic for an extra appointment once a month. Every Friday, I would ring in with my sugar level readings, so I got extra care when I was pregnant. I also took part in work for a Core Outcome Set for the treatment of pregnant women with pregestational diabetes. 

Why is it important for patients to participate in clinical trials? 

It takes a bit of extra time, but if there were no clinical trials, I would not be here today. I am delighted to be able to take part in them — it is very satisfying and rewarding. 

If you’re uncertain about getting involved, speak
to healthcare professionals and ask questions.

What is the value of patient input in clinical trials? 

Professor Dunne from the School of Medicine at University of Galway heads the clinical trials and is doing a lot for diabetes research. She recognises the value of having patients on board and bringing patient expertise to the forefront. 

What is your message to people considering participation in clinical trials? 

I will definitely take part in future trials and would encourage others to participate. If you’re uncertain about getting involved, speak to healthcare professionals and ask questions; trials are safe to participate in, and you get extra care. 

Why is it so important going forward? 

It’s for the future; I see children nowadays who have diabetes and have their glucose monitors and insulin pumps whereas, when I was diagnosed, I was pricking my finger 10 times a day and doing my insulin injections. That shows how vital research is. 

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A series of Irish-led studies are shedding light on how best to treat gestational diabetes, a condition in which diabetes develops during pregnancy. 

Gestational diabetes (GDM), resulting in high blood sugar levels, requires close monitoring of mother and baby during pregnancy. Fidelma Dunne, Personal Professor in Medicine at University of Galway and Consultant Endocrinologist at Saolta University Health Care Group, has overseen dramatic changes in how hospitals diagnose and monitor the condition.

“In 2003, I was tasked with delivering diabetes in pregnancy services in Galway but could not find any up-to-date facts on either pregestational diabetes or GDM. So, with funding from the Health Research Board (HRB), we established the ATLANTIC – DIP network and set about generating up-to-date information along the Irish Atlantic seaboard by combining newly generated data from five hospitals providing antenatal clinical services,” she says. 

Better way to treat gestational diabetes 

Women with GDM who did not gain excessive weight had better pregnancy outcomes. Women who needed insulin struggled more with weight management. After reviewing the literature, Prof Dunne and her research team wondered if a long-established diabetes tablet could reduce complications and improve results for mothers with GDM and their babies.

This led to the EMERGE trial, the first placebo-controlled study of metformin for GDM. “Women who were assigned metformin had a 25% reduction in the need for insulin. They also had better glucose control and less weight gain. Additionally, their babies were less likely to be very big at birth,” she explains.

Women who were assigned metformin had
a 25% reduction in the need for insulin.

The study, presented at the American Diabetes Association meeting (June 2023), also found no increase in pre-term delivery, which was a concern raised in previous research. She adds: “The research and clinical community know that insulin availability for GDM is a problem in many low-income countries. If we could substitute metformin for insulin, this may have global benefits as metformin is cheap, readily available and easy to administer.” 

Study leads to change in NICE guidelines 

Prof Dunne’s team was also involved in the CONCEPTT TRIAL. It looked at whether continuous glucose-monitoring (CGM) technology in pregnancy helped women with type 1 diabetes gain better glucose control compared to usual finger-pricking devices and whether this technology led to fewer complications.

She explains: “The CONCEPTT trial showed that CGM provides better glucose control and reduces the likelihood of babies born with excessive weight. Use of CGM leads to better pregnancy outcomes and is also cost-effective. NICE guidelines now recommend that pregnant women with type 1 diabetes should be offered CGM. Continued investment in diabetes in pregnancy research will help to ensure that appropriate and timely screening, treatment and post-pregnancy follow-up are offered — improving health outcomes for mothers and babies.”

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