Clinical Trials Q1 2024 Archives - Health News https://www.healthnews.ie/topic/clinical-trials-q1-2024/ News, information and personal stories Wed, 03 Apr 2024 08:15:25 +0000 en-US hourly 1 https://s3.eu-north-1.amazonaws.com/cdn-site.mediaplanet.com/app/uploads/sites/94/2019/05/07211431/cropped-health-ie-logo-32x32.png Clinical Trials Q1 2024 Archives - Health News https://www.healthnews.ie/topic/clinical-trials-q1-2024/ 32 32 Enabling meaningful patient involvement for healthcare innovation and access https://www.healthnews.ie/clinical-trials/enabling-meaningful-patient-involvement-for-healthcare-innovation-and-access/ Wed, 27 Mar 2024 14:24:19 +0000 https://www.healthnews.ie/?p=11171 Empowering patients can lead to better healthcare access and research innovation. Their voices must be heard through inclusive policies and patient involvement. Irish patients have a right to access the medicines, treatment, devices and procedures they need, including innovations that could be life-changing or life-saving. However, this is not always the case.    Improving access to … Continued

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Dr Derick Mitchell

CEO, IPPOSI

Empowering patients can lead to better healthcare access and research innovation. Their voices must be heard through inclusive policies and patient involvement.


Irish patients have a right to access the medicines, treatment, devices and procedures they need, including innovations that could be life-changing or life-saving. However, this is not always the case.   

Improving access to vital treatments  

Irish patients often encounter unequal access to therapies compared to other European countries. Certain treatments may not be approved for reimbursement in the public system or approved treatments experience delays and funding gaps. Additionally, differences exist in available treatments for those with or without private health insurance, particularly oncology treatments. 

For patient-centred care, the Department of Health and the HSE must reform the assessment and reimbursement process and ensure sustained access for patients from 2025–2035. This involves partnering with EU Member states to increase treatment access and investing in Irish clinical research infrastructure, facilitating early access to innovative treatments. 

Empowering patients through treatment innovation  

Patients bring unique insights and perspectives to the healthcare landscape. By actively involving patients in decision-making processes (clinical trial design, drug development, treatment planning), healthcare stakeholders gain a deeper understanding of patient needs, leading to treatment innovation and access.  

IPPOSI empowers patients and the public by providing them with inclusive supports, education and tools to become influential partners in healthcare decision-making. Empowered patients are more inclined to engage in decision-making processes at the individual care level plus multiple levels of service delivery.

IPPOSI empowers patients and the public
by providing them with inclusive
supports, education and tools.

Fostering inclusive healthcare partnerships  

We encourage the Department of Health to integrate patient involvement and person-centredness into legislative, regulatory and policy initiatives, extending this mandate to the HSE and affiliated health agencies.

By incorporating patient feedback and lived experiences, healthcare can pinpoint delivery gaps, enhance resource allocation and broaden access to innovative treatments for a broader range of patients.

Aligned with Sláintecare objectives, patient involvement helps identify access barriers including geography and socioeconomic disparities. This prompts strategies for equitable healthcare access, regardless of background or circumstances.

Establishing a Patient and Carers Advisory Board with direct access to the Minister for Health and the Secretary-General of the Department of Health could enhance national communication.

The research community and health industry must intensify efforts to involve patients and the public, fostering trusted partnerships to advance mutual objectives.  

Prioritising patient-centred research and implementation  

There should be no debate about whether to involve patients or not. All discussions and decisions around access and research innovation must be person-centred and informed by patients’ lived experiences. 

The Irish Platform for Patient Organisations, Science and Industry (IPPOSI) is a patient-led organisation that works with patients, government, industry, science and academia to put patients at the heart of health policy and innovation. Learn more: ipposi.ie

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Medical device trials to transform cardiovascular healthcare delivery in Ireland https://www.healthnews.ie/clinical-trials/medical-device-trials-to-transform-cardiovascular-healthcare-delivery-in-ireland/ Wed, 27 Mar 2024 12:24:22 +0000 https://www.healthnews.ie/?p=11135 Clinical trials underway across Ireland are putting advancements in cardiovascular medical technology to the test, allowing groundbreaking new medical devices to be brought to market. As advancements in technology move faster than ever, healthcare technology companies bridge the gap between the ever-growing burden of disease and the need for efficient healthcare solutions. Medical devices improving … Continued

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Ronan Rogers

Senior Research & Development Director, Medtronic

Dr Faisal Sharif

Professor of Cardiovascular Translational Research and Innovation;
Consultant Interventional Cardiologist; Non-Executive Director BioInnovate Ireland

Clinical trials underway across Ireland are putting advancements in cardiovascular medical technology to the test, allowing groundbreaking new medical devices to be brought to market.


As advancements in technology move faster than ever, healthcare technology companies bridge the gap between the ever-growing burden of disease and the need for efficient healthcare solutions.

Medical devices improving cardiac conditions

Prof Faisal Sharif, Professor of Cardiovascular Translational Research and Innovation, pioneered two groundbreaking medical devices, showcasing the work being developed in the cardiology space.

  1. Remote monitoring device for heart failure

“Cardiac pressures are known to change for one week before a patient gets unwell. With use of a remote patient cardiac pressure measurement device, frail and elderly patients with heart failure can be monitored at home. Changes to their cardiac pressures can be identified and treated before the patient gets to the point of emergency hospitalisation,” explains Dr Sharif.

2. Renal artery denervation for uncontrolled blood pressure

Hypertension or high blood pressure is a health concern affecting one in three people globally. Healthcare technology company Medtronic has developed an innovative device to treat hypertension, which can produce a much-needed drop in blood pressure. “Long-term high blood pressure causes heart disease, stroke and other health complications; development of this new therapy creates an innovative approach to treating a widespread problem,” says Prof Sharif.

How clinical trials transform healthcare

Medical devices can be transformative but must be patient-friendly in their application. They offer a chance to revolutionise healthcare by enabling innovative treatments and remote patient monitoring, potentially reducing hospitalisations and preventing health deterioration.

They also offer alternative treatments, which can work synergistically with pharmaceutical options. Clinical trials provide strong scientific evidence of safety and benefit to the patient prior to a device attaining approval for widespread population use.

Ronan Rogers, Senior Research and Development Director of Medtronic, discusses the scale and extent of bringing medical devices to market, with the help of clinicians like Dr Sharif. “Our technology improves the lives of around two patients every second. At any one time, we are running around 400 clinical trials globally,” insists Rogers. “Trials are producing the evidence needed to establish best clinical practice, informing strategy and future policy.”

Trials are producing the evidence needed
to establish best clinical practice,
informing strategy and future policy.

Networks for enhanced clinical outcomes

Conducting clinical trial activity in Ireland requires national collaboration to operate at scale, according to Rogers. “We are fortunate in Ireland to have highly skilled healthcare professionals, a widespread research network and meaningful links to academic institutes allowing us to achieve this,” he says.

“Medtronic has conducted a number of clinical trials in Ireland, including one focused on the treatment of hypertension, and has benefited from a really strong clinical research team, including highly-trained research nurses, data managers and researchers, allowing us to produce high-quality clinical research data.”

In environments prioritising clinical research, the quality and capacity of care are elevated, leading to enhanced clinical outcomes for patients. Rogers and Sharif specifically acknowledge the significant contribution of the Irish community, highlighting their pivotal role in these advancements. “We want clinical trials to be meaningful, and patients are regularly involved in the design of our trials across Ireland,” says Dr Sharif.

Ireland’s medical technology landscape

With extensive government support from the Department of Further and Higher Education, Research, Innovation and Science, the Department of Health and the Health Research Board, Ireland’s clinical research infrastructure continues to expand.

Rogers emphasises: “We have all the necessary components of the ecosystem in Ireland; we have the ability to do more. If we can align the various stakeholders involved and speed up the process to get the clinical trials started and provide sustainable research posts, the possibilities could be endless.”

In Ireland, medtech companies are at the forefront of groundbreaking advancements in medical technology, harnessing a unique blend of cutting-edge technology, scientific expertise and a connected ecosystem. These collaborative efforts are driving the development of innovative solutions to tackle complex medical conditions.

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Trials bring access to latest treatments for oncology patients https://www.healthnews.ie/clinical-trials/trials-bring-access-to-latest-treatments-for-oncology-patients/ Wed, 27 Mar 2024 09:35:11 +0000 https://www.healthnews.ie/?p=11116 Streamlining our processes and regulations around clinical trials is vital for keeping Ireland globally competitive. We’re only as fast as our slowest part. Cancer clinical trials allow patients access to the latest available treatments. They create an environment of inquiry and standards, and they accelerate innovation. They enable us to bring patients newer treatments years … Continued

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Prof Seamus O’Reilly

Medical Oncologist & Clinical Lead, Cancer Trials Ireland

Streamlining our processes and regulations around clinical trials is vital for keeping Ireland globally competitive. We’re only as fast as our slowest part.


Cancer clinical trials allow patients access to the latest available treatments. They create an environment of inquiry and standards, and they accelerate innovation. They enable us to bring patients newer treatments years before they would come into place if we waited until they were approved and reimbursed by the Government.

Oncology research in Ireland

Oncology is also at an exciting stage within Ireland, with many new agents in the pipeline. For example, there is a drug class called antibody-drug conjugates, and there are 160 of these in development globally. Creating an environment in our hospitals where patients have access to this innovation is of great significance.

Streamlining processes and regulations

Cancer Trials Ireland has four themes for the next four years, the first of which is ‘streamlining.’ We need to be efficient in bringing trials into Ireland and remove as many barriers as possible. We are competing with other countries, so our processes and regulations — particularly around GDPR — must be streamlined. Much like other enterprises, you’re only as good as your weakest link, and you’re only as fast as your slowest part.

The second theme is bringing more studies into Ireland. Getting patients access to the studies arising from the 160 antibody-drug conjugates is a key objective for our organisation.

We look at ways of nurturing the next generations so they can you know be involved in clinical trials. It is not just about doctors.

Growth through succession

The third theme is succession. In any organisation, we need to nurture the next generation. We look at ways of nurturing the next generations so they can you know be involved in clinical trials. It is not just about doctors.

Building an infrastructure where we can encourage, recruit and retain nurses and data managers in our system is also hugely important. If you don’t have a team, you can’t build around it.

Sustainability initiatives

The final theme is sustainability. Healthcare itself is very climate-unfriendly, while fossil fuel pollution contributes to cancer. In France, they calculated that 3% of their breast cancer cases are due to fossil fuel pollution from cars. It’s a worsening problem that we are all affected by. In 2022, we set up the National Green Cancer Clinical Trials initiative, and we’ve established a green charter for cancer trials in Ireland. Our group also published a paper last year called ‘Climate Toxicity’— the first time the term has been used in medical literature

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Tackling challenges and taking clinical trial design into the future https://www.healthnews.ie/clinical-trials/tackling-challenges-and-taking-clinical-trial-design-into-the-future/ Tue, 26 Mar 2024 17:14:19 +0000 https://www.healthnews.ie/?p=11112 Decades of research are yielding promising avenues to manage and potentially cure numerous severe diseases. However, significant challenges lie ahead. Rapid advancements in medical science are leading to exciting possibilities in clinical trials. New treatments like immune system enhancers for previously untreatable cancers offer hope for long-term remission. While complete eradication of diseases might not … Continued

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Dr Robert O’Connor

Director, HRB-National Clinical Trials Office

Decades of research are yielding promising avenues to manage and potentially cure numerous severe diseases. However, significant challenges lie ahead.


Rapid advancements in medical science are leading to exciting possibilities in clinical trials. New treatments like immune system enhancers for previously untreatable cancers offer hope for long-term remission.

While complete eradication of diseases might not always be the outcome, gradual progress is already clearly evident in the increasing number of individuals surviving serious illnesses like cardiovascular disease.

Evolutions in trial design

Trial methodologies are also evolving. Traditionally, trials focused on one medicine/technology addressing a single disease. Now, complex approaches like platform, umbrella and basket trials allow for simultaneous testing of various approaches against multiple aspects of a disease, leading to faster and more efficient results.

Additionally, with a deeper understanding of diseases, we’re witnessing a shift towards individualised medicine and once common illnesses are being classified into unique subtypes, paving the way for personalised treatment plans.

Truly personalised medicine

Gene editing, cellular therapies and novel vaccines are at the forefront of revolutionary advancements. Trials are exploring the potential of correcting faulty genes within the body or engineering immune cells or the wider immune system to combat diseases. Such trials are already underway in specialist centres in our nation.

Trial regulation grows ever more complex and costly.

It is also likely that we will increasingly see technology and medical approaches merged to give the best performance for a particular individual, and there is no doubt that machine learning (often misnamed AI) will increasingly figure, too.

Patients leading the way

Patient-centric trials are another crucial development. Previously often overlooked, patient needs and perspectives are now being increasingly prioritised. Patients actively participate in shaping trial design, ensuring clear communication and helping identify outcomes that directly impact their human wellbeing rather than the disease itself.

Advances come with challenges

Trial regulation grows ever more complex and costly. Regulations are vital. However, increasingly, lack of investment in the extra cost of regulation is impeding progress, and regulation without resourcing can wreck purpose.

Lifesaving technology comes at an increasing cost and, indeed, the first multimillion-euro treatment has recently been approved for a rare condition in Ireland. The economics of a ‘cure’ will increasingly tax us intellectually and practically, as will the growing tide of patients who can have great extensions to their lives but require ongoing and costly treatment.

Hence, arguably, we are reaching a new frontier where the challenges around trials and health technology are increasingly societal rather than scientific.

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Taking actionable steps together to find a cure for motor neurone disease https://www.healthnews.ie/clinical-trials/taking-actionable-steps-together-to-find-a-cure-for-motor-neurone-disease/ Tue, 26 Mar 2024 16:29:26 +0000 https://www.healthnews.ie/?p=11091 Irish patient participates in trial informing development of new drugs for motor neurone disease. While on stage at the Dublin Fringe festival, actor and writer Michael Campbell tripped and fell. Eight months later, he was diagnosed with a rare type of inherited motor neurone disease (MND), for which there is no cure. Motor neurone disease … Continued

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Professor Martina Hennessy

Director of the Wellcome-HRB Clinical Research facility at St James’s Hospital and Trinity College, Dublin

Mr Michael Campbell

Participant in the Motor Neurone Clinical Trial at the Wellcome-HRB Clinical Research facility at St James’s Hospital

Photographer – Gabrielle Masterson

Irish patient participates in trial informing development of new drugs for motor neurone disease.


While on stage at the Dublin Fringe festival, actor and writer Michael Campbell tripped and fell. Eight months later, he was diagnosed with a rare type of inherited motor neurone disease (MND), for which there is no cure.

Motor neurone disease

Motor neurone disease affects the nerves and brain. Symptoms include muscle weakness, slurred speech and difficulty swallowing, progressively increasing over time; most cases are sporadic with around 10% of cases inherited. Campbell’s case was especially rare, stemming from a fault in his FUS gene, occurring in approximately 300 people worldwide.

Campbell’s father died from the same disease. Although stunned by the diagnosis, he immediately contacted Professor Orla Hardiman, Ireland’s leading neurologist for MND and began seeking clinical trials of new drugs. He found one just beginning at St James’s Hospital.

MND clinical research facility

“The standard of care has been nothing short of amazing. I am constantly being checked in on, and I feel like part of the team,” Campbell says. Although the outcome is not guaranteed, he knows this is an “actionable step forward to identifying a potential treatment,” he says.

Provide greater access to innovative medicines.

Research centres improving outcomes

Opened in May 2013, the Wellcome-HRB purpose-built clinical research facility (CRF) has grown from strength to strength, supporting a wide variety of clinical trials and studies and specialising in early-phase and advanced therapy trials. Professor Martina Hennessy, its Director, shines a light on how research improves clinical outcomes.

She says: “Evidence shows that research-performing hospitals, including clinical trials, provide greater access to innovative medicines, make better use of evidence, offer more precise care, attract more highly qualified staff, have better facilities and greater capacity to develop novel approaches to the least well-served diseases.”

Patient engagement for progress

“With patients and clinicians working in partnership … we can design better trials that begin to unlock the potential of new medicines. Irish patients are positive about engaging with research and about contributing to the quality of the data, which informs the development of new drugs worldwide,” she says.

“They do it for themselves but also their families and society. The outcome is unknown, but CRF staff are with them every step … to make it as safe as possible,” explains Prof Hennessy.

She stresses the importance of working with patients with rare diseases. “With patients like Campbell as part of the team, there is always hope,” she insists. Today, Campbell is continuing to write and act — showcasing that life perseveres despite the challenge of disability, thanks to today’s research landscape.

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Drive for patient participation to advance lupus clinical trials in Ireland https://www.healthnews.ie/clinical-trials/drive-for-patient-participation-to-advance-lupus-clinical-trials-in-ireland/ Tue, 26 Mar 2024 16:08:12 +0000 https://www.healthnews.ie/?p=11090 A global biopharmaceutical company is empowering patient involvement in clinical trials, for the advancement of new treatments. Lupus, a widespread chronic autoimmune illness, impacts millions globally (Lupus UK), affecting various organs and systems. It arises when the immune system attacks one’s own tissues and organs. Its cause remains unknown, necessitating additional research for new treatments … Continued

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Laura Clifton-Hadley

Associate Director, Clinical Operations UK & Ireland, Bristol Myers Squibb

Jill Mullan

Senior Medical Science Liaison, Innovative Medicines, Bristol Myers Squibb

A global biopharmaceutical company is empowering patient involvement in clinical trials, for the advancement of new treatments.


Lupus, a widespread chronic autoimmune illness, impacts millions globally (Lupus UK), affecting various organs and systems. It arises when the immune system attacks one’s own tissues and organs. Its cause remains unknown, necessitating additional research for new treatments that can change the course of the disease.

Lupus research in Ireland

Ireland stands at the forefront of pioneering efforts to combat lupus. With an extensive research infrastructure, strong collaborative networks, government support and ongoing academic excellence, Ireland is primed to conduct clinical trials focused on key areas of unmet patient need.

Treating lupus poses challenges due to its symptoms often resembling those of other conditions and its varied impact on individuals’ immune systems. Finding the right treatment for each person’s lupus is crucial. Insights gained from studying lupus could also help us understand and treat other autoimmune conditions.

Raising awareness of clinical
trials is vital to ensure uptake.

Global pharmaceutical involvement

Laura Clifton-Hadley, Associate Director of Clinical Operations and Jill Mullan, Senior Medical Science Liaison of Bristol Myers Squibb, highlight the clinical trials underway to develop potential treatments, ranging from small molecules and biologics to cell therapies.

“We are investigating potential new medicines for Systemic Lupus Erythematosus (SLE), which is a very complex disease affecting more women than men and disproportionately impacting ethnic minorities,” says Clifton-Hadley.

By advancing lupus research, such disparities in healthcare outcomes can be addressed, ensuring all individuals affected by the disease receive equitable access to effective treatments and care.

“We are trying to bring the right medicines to the right patients faster,” adds Mullan. “Lupus is currently treated using a wide variety of medicines. Not all currently approved treatment options work for everyone, making this an important area in which to keep looking for potential new treatments.”

Patient engagement and awareness

Clinical trials are being conducted nationally, ensuring their accessibility to patients across Ireland. Patient involvement is the cornerstone of all clinical trials. “Patients are playing a part in science for themselves and future patients, getting a sense of comfort and an increased sense of physician involvement throughout,” insists Clifton-Hadley.

Stressing the importance of encouraging patient involvement, she says: “Raising awareness of clinical trials is vital to ensure uptake.”

Mullan adds: “We actively welcome participant diversity, going above and beyond to make sure participants from a variety of ethnic backgrounds and cultures have access to the information they need.”

Whether lupus or another condition with limited treatment options, Clifton-Hadley and Mullan encourage people affected to explore their options, as clinical trials are underway across Ireland.

Speak to your doctor about available trials, or go to clinicaltrials.gov 


IMM-GB-2400122
March 2024

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Critical role of biobanks in clinical trials and how to sustain them https://www.healthnews.ie/clinical-trials/critical-role-of-biobanks-in-clinical-trials-and-how-to-sustain-them/ Tue, 26 Mar 2024 15:25:24 +0000 https://www.healthnews.ie/?p=11074 Clinical trials across Ireland are utilising biological samples stored in biobanks to advance understanding of disease and develop tailored medications. In recent decades, recognition of the central role of biological specimens in disease understanding, biomarker identification and targeted therapy development has surged. This has led to the widespread establishment of biobanks as vital repositories, offering … Continued

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Professor Richard Flavin

Director and Chairman, Biobank Ireland Trust

Clinical trials across Ireland are utilising biological samples stored in biobanks to advance understanding of disease and develop tailored medications.


In recent decades, recognition of the central role of biological specimens in disease understanding, biomarker identification and targeted therapy development has surged. This has led to the widespread establishment of biobanks as vital repositories, offering researchers access to essential biological samples and data for various studies.

Biobanks supporting clinical practice

Prof Richard Flavin, Director and Chairman of Biobank Ireland Trust, explains the importance of biobanks for medical research. “A biobank collects patient samples and associated healthcare data, samples are then used to answer important clinical research questions — samples help us to understand how the human body behaves in health and disease, helping us develop new treatments,” he says.

Biobank Ireland Trust, a charity established in 2004, facilitates the development of hospital-based biobank networks in Ireland, enabling translational research collaborations and clinical trials. Prof Flavin explains: “We work with a number of biobanks in different areas of health, including cancer research, Covid-19 and more.”

We work with a number of biobanks
in different areas of health, including
cancer research, Covid-19 and more.

Biobank application in breast cancer trial

Biobanks accelerate research aimed at developing medicines and treatments. They bridge the gap between the patient and the development of precise, tailored treatment options. One such example is Trastuzumab, developed through a health research biobank and used in breast cancer treatment.

Challenges in sustaining biobanks

However, accessing samples from biobanks requires researchers to navigate stringent regulations encompassing ethical and legal considerations. Comprehensive patient consent and data regulatory procedures established nationally and at an EU level must be strictly adhered to. Furthermore, the effectiveness of biobanks in facilitating clinical trial delivery hinges on securing adequate funding.

Prof Flavin explains: “Biobanks are the keystone for advancements in medicine, but they are lacking sufficient funding and resources. We need further investment in infrastructure, staffing and equipment.”

To sustain the advantages afforded by biobanks, public and patient involvement is key. Strict data confidentiality measures are in place, empowering individuals to engage with biobanks that play a pivotal role in advancing research.

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Why patient-centred trials lead the way in developing treatment https://www.healthnews.ie/clinical-trials/why-patient-centred-trials-lead-the-way-in-developing-treatment/ Tue, 26 Mar 2024 15:10:41 +0000 https://www.healthnews.ie/?p=11061 Leveraging academic and clinical expertise centred on patient involvement can draw forth better clinical outcomes and more effective, innovative treatments. As the incoming director of the Clinical Research Facility at University College Cork (CRF-UCC), Professor Fai Ng believes there is a huge opportunity to develop the centre’s research infrastructure, with people from all sectors at … Continued

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Professor Fai Ng

Director, CRF-UCC

Professor Barry Plant

Consultant Respiratory Physician and Clinical Lead, Respiratory Medicine, CUH

Professor Sinead Harney

Consultant Rheumatologist, CUH

Dr Frances Shiely

Director of Education, CRF-UCC

Leveraging academic and clinical expertise centred on patient involvement can draw forth better clinical outcomes and more effective, innovative treatments.


As the incoming director of the Clinical Research Facility at University College Cork (CRF-UCC), Professor Fai Ng believes there is a huge opportunity to develop the centre’s research infrastructure, with people from all sectors at the core.

Benefits of patient-centred trials

As Professor of Rheumatology and former Director of the NIHR Newcastle CRF, Ng underlines the importance of staff, Principal Investigators (PIs), industry partners and patients working together. He believes that CRF-UCC has the potential to become country-leading in Ireland, and internationally, as researchers develop new therapies.

The facility is co-funded by the Health Research Board and the College of Medicine and Health and can thus leverage academic and scientific excellence alongside clinical expertise across all medical specialties.

“Clinical trials are important if we want to develop new and better medicines, but there are economic benefits as well,” adds Ng, who takes up his new post on April 15.

Clinical trials for revolutionary drugs

The facility has an established track record in developing treatments in all therapeutic areas from laboratory through clinical trials. For instance, from its initial work with the cystic fibrosis (CF) drug ivacaftor in 2011, it has continued to engage with clinical trials, including with ETI (elexacaftor-tezacaftor-ivacaftor) for CF, explains Professor Barry Plant, Consultant Respiratory Physician, Clinical Director for Medicine and Director of the Adult Cystic Fibrosis Centre at Cork University Hospital (CUH).

“These new CF drugs are transformative and revolutionising patient care,” he adds. Several CF patients being treated at CUH are involved in trials with new drugs and studies. Many participated in the CFMATTERS trial assessing how best to use intravenous antibiotics for infections in CF patients.

Professor Plant explains telehealth and telemedicine approaches have also been supported to expand options for care delivery. His group is working with European bodies on these initiatives and looking at new ways of microbiology sampling to minimise cross-contamination and infection risk for patients, using next-generation bronchoscopy.

These new CF drugs are transformative and revolutionising patient care.

Professor Barry Plant

Patient-focused research

The CRF-UCC endeavours to deliver an infrastructure that enables busy academics and clinicians to conduct high-quality clinical research by providing access to expert staff including research nurses and statisticians, plus support around governance and ethics, and a patient-centred research environment

Professor Sinead Harney, Consultant Rheumatologist at CUH and Honorary Clinical Professor at UCC, highlighted how CRF-UCC has enabled her to remain active in clinical trials and address ongoing ‘unmet needs’ for rheumatology patients.

She is PI in Cork for the IDEA-FAST study that covers 14 other European countries investigating fatigue across inflammatory and neurodegenerative conditions. Other research areas include psoriatic arthritis and lupus.

Relevant outcomes for patients

Dr Frances Shiely, Director of Education at the CRF, says patients are playing increasing roles in clinical trials. “Twenty years ago, we used to do trials on patients,” she says. “Now, we do trials with patients.”

Patient and Public Involvement (PPI) sees patients working with researchers on trial design, recruitment, communication and dissemination of study findings ranging from new drugs to community-based interventions. There is also a move towards more decentralised clinical trials.

PPI leads to better-quality, more efficient trials with better recruitment and design, delivering more relevant outcomes for patients. “You can only do that when you work with the patients,” adds Dr Shiely.

Clinical trials previously involved patients as passive subjects. Today, trials engage with patients as active collaborators. This shift empowers patients, fostering a deeper partnership between researchers and those with lived experiences.

The CRF also offers a postgraduate certificate, postgraduate diploma and master’s degrees in clinical trials (online) and conducts funded research projects to create inclusive clinical trials, plus training and education on increasing involvement in underserved groups.

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Compliance experts ensuring ethical promotion of medicines in Ireland https://www.healthnews.ie/clinical-trials/compliance-experts-ensuring-ethical-promotion-of-medicines-in-ireland/ Tue, 26 Mar 2024 14:44:16 +0000 https://www.healthnews.ie/?p=11056 Pharmaceutical companies are committed to the ethical promotion of medicines, navigating outdated legislation with the help of market-leading compliance experts. Clinicians are expected to keep up with all new treatments and advances, which is no easy feat. However, those who choose to collaborate with pharmaceutical companies get direct access to current treatment insight, including efficacy … Continued

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Caroline Kelly

Founder and Managing Director, Pharma Integrity

Pharmaceutical companies are committed to the ethical promotion of medicines, navigating outdated legislation with the help of market-leading compliance experts.


Clinicians are expected to keep up with all new treatments and advances, which is no easy feat. However, those who choose to collaborate with pharmaceutical companies get direct access to current treatment insight, including efficacy and safety information, to enable informed decisions.

Data compliance in medicine promotion

Companies must adhere to strict regulations regarding the use of data obtained from clinical trials for medicine advertising. They are required to promote the rational use of medicinal products, aligning with approved indications, appropriate patient populations plus correct dosage and administration while emphasising usage precautions. Ultimately, clinicians must balance medicine efficacy with safety considerations.

Commitment to ethical promotion

Caroline Kelly, Founder and Managing Director of Pharma Integrity, a female-led healthcare consultancy, advises pharmaceutical companies on compliance excellence. She explains: “Pharmaceutical companies are unanimous at putting patients front and foremost. To achieve this, the amount of internal resourcing, funding, training of staff, internal structures, processes and standards, which go into all their activities, is vast.”

Ultimately, clinicians must balance
medicine efficacy with safety considerations.

Challenges of outdated legislation

The statutory instrument, which governs the advertising of medicines in Ireland, hasn’t been updated since 2007. According to Kelly: “Companies are being provided with new opportunities, systems and manners in which they can engage with healthcare professionals, patients and the public, which do not fit into the structures of existing legislation or industry codes of practice.”

It is becoming increasingly difficult for pharmaceutical companies to optimise internal processes while continuing to align with such outdated legislation.

Medicine promotion ethics for public health

Holding extensive industry experience, Kelly is passionate about the work being done behind the scenes to ensure ethical promotion of medicines. Pharma Integrity is uniquely positioned to navigate both the UK and Ireland with operational confidence.

She says: “The industry is under a lot of scrutiny from the regulator for non-compliance of advertising; companies genuinely want to know what they can be doing differently and better, and Pharma Integrity provide the forum for them to achieve that.”

Providing a host of innovative services, events and programmes are tailored to individual companies’needs, including a cross-industry compliance network championing good practice between all. “Today, stakeholders — health professionals, payers, patients and the public — care about ‘how’ you have achieved successes, not just ‘what’ you have achieved. Reputation matters,” she adds.

With market-leading compliance experts helping behind the scenes, we can have confidence that the pharmaceutical industry is ensuring the best for patients, healthcare professionals and the public.

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Empowering hope by investing in lifesaving cancer trials https://www.healthnews.ie/clinical-trials/improving-cancer-care-in-ireland/ Thu, 21 Mar 2024 16:52:57 +0000 https://www.healthnews.ie/?p=11022 We must support clinical trial research to ensure that Irish cancer patients have access to innovative and novel cancer treatments and approaches. A key priority for the Irish Cancer Society is investing in world-class cancer research that will have an impact on people affected by cancer in Ireland. The Irish Cancer Society is the largest … Continued

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Dr Claire Kilty

Head of Research, Irish Cancer Society

We must support clinical trial research to ensure that Irish cancer patients have access to innovative and novel cancer treatments and approaches.


A key priority for the Irish Cancer Society is investing in world-class cancer research that will have an impact on people affected by cancer in Ireland.

The Irish Cancer Society is the largest voluntary funder of cancer research in Ireland. Every year, we invest €3.7 million, on average, in over 100 researchers working all across the country to improve cancer outcomes.

We provide over €1 million of funding every year to Cancer Trials Ireland, the leading cancer research trials organisation in Ireland. Through this investment, the Cancer Trials Ireland team work hard to drive and attract a broad trial portfolio to Ireland across a range of cancer types.

Trials improve patient outcomes today

Each year in Ireland, thousands of people affected by cancer are participating in hundreds of clinical trials across the island. For some cancer patients, trials may be the best treatment option for them, especially those who may have exhausted previous treatment options.

In addition to trials focused on improving patient outcomes through new treatment modalities, we are also passionate about ensuring Irish patients have access to cutting-edge studies centred on improvements in their cancer care and quality of life. For example, trials focusing on diet and exercise interventions have shown success for some individuals living with and beyond cancer.

Each year in Ireland, thousands of people affected by cancer are participating in hundreds of clinical trials across the island.

Research talent and expertise

Alongside a direct focus on cancer trials, it is also vital to foster and cultivate research talent and create an environment where pioneering clinical trials research can be developed. To do this, the Irish Cancer Society provide dedicated research buy-out time for oncology-based clinicians to allow them the time to develop new research ideas. Ultimately, we want people affected by cancer nationwide to have access to the best clinical research expertise.

Trials are the driving force behind improvements in cancer care and the hero of happy endings. We know that cancer research both in Ireland and globally lost valuable time during Covid — time that we can’t afford and need to catch up on as soon as possible.

To do this, we, as a community, all need to work together to do everything we can to ensure that people affected by cancer in Ireland have access to world-class clinical trials and expertise.

There is still time to support the Irish Cancer Society’s Daffodil Day by making a donation: cancer.ie

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