Radiotherapy is vital in cancer treatment, yet research funding is limited. One Irish research group is expanding access to clinical trials, improving outcomes for patients.

The Irish Research Radiation Oncology Group (IRROG) is a national clinical trials group funded by the Health Research Board (HRB), which also receives charity funding from St Luke’s Institute of Cancer Research. Despite radiotherapy being used to treat half of cancer patients, radiotherapy research only receives 3% of cancer research funding globally. The group plays a key role in improving the national radiotherapy research infrastructure, enhancing national and international collaboration, streamlining research procedures and increasing access to clinical trials for radiotherapy patients across Ireland.

Importance of radiotherapy trials

Radiotherapy is a major cancer treatment which is constantly evolving. Improvements in radiotherapy design and delivery significantly increase patients’ chances of cure and treatment outcomes. Moreover, radiotherapy contributes to 40% of cancer cures. Patients who participate in clinical trials have higher cure rates, and all patients treated in research-active hospitals that engage in clinical trials have better outcomes. Therefore, all patients benefit when their hospitals achieve the international standards of excellence mandated for clinical trials.

Radiotherapy is a major
cancer treatment which
is constantly evolving.

Expanding access to clinical trials

Since the formation of IRROG, the number of patients accessing interventional clinical trials in radiation oncology has increased from 74 in 2021 to 234 in 2024. In 2024, 16 trials were opened in radiation oncology departments across the country; five new trials opened in breast cancer, prostate cancer, head and neck cancer and pancreatic cancer. In 2025, the number of trials open around the country in radiation oncology is set to double. IRROG is currently coordinating four Irish investigator-designed clinical trials, with three more in the development phase.

Future goals and investment needs

The Irish National Cancer Strategy (NCS) states that every patient has a right to access a clinical trial, and yet, only 2% of patients currently access new treatments as part of a clinical trial. A target of 6% has been set by the NCS, but to achieve this, significant investment will be required. In 2024, St Luke’s Radiation Oncology Network exceeded this target, with 206 patients accessing new treatments as part of a clinical trial. As clinical lead of IRROG, I hope to improve cancer cure rates and outcomes through high-quality clinical trials so that patients can access the right trial for them.

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Every breakthrough medicine exists because clinical trials prove its safety and effectiveness. Ireland’s clinical research sector offers patients access to innovative treatments while contributing to global medical advancements.

Currently, hundreds of clinical trials are active across the country, spanning various therapeutic areas including cancer, cardiovascular disease, respiratory conditions and rare diseases.

Trials in your community

Trials are conducted at major teaching hospitals, dedicated research centres, some private hospitals as well as through some local GPs and primary care facilities. Each of our major hospital groups has dedicated infrastructure to undertake trials and with a highly educated workforce, strong regulatory oversight and highly engaged patients, our country provides a supportive environment for this vital contribution to improving health.

Each trial undergoes rigorous
independent ethical review to
ensure patient interests and safety.

Clinical trial process decoded

Some trials may involve a new medicine, device or procedure being developed by a global pharmaceutical company or a startup. Other trials may originate from doctors trying to better understand and compare the outcomes of already long-established treatments. All are governed and overseen to the same strict levels of safety and stringency in this county using regulations and processes that are common across the EU.

For patients considering participation, they should enquire and discuss with their doctor. Each trial undergoes rigorous independent ethical review to ensure patient interests and safety. Patients will be provided with details to understand the trial benefits and risks and how their welfare will be protected in a process known as ‘informed consent.’

The success of clinical trials in Ireland relies heavily on collaboration between academic institutions, healthcare providers and the pharmaceutical industry. This partnership approach has created a dynamic research ecosystem that attracts significant international investment while ensuring Irish patients have early access to cutting-edge treatments.

The path forward for Irish clinical trials

Looking ahead, Ireland’s position in clinical research continues to strengthen. Public awareness about clinical research is helping to boost engagement across communities, and there is now strong government support for further growth in clinical trial activity articulated in the programme for government.

For those interested in participating in or learning more about clinical trials, resources are readily available through healthcare providers, hospital research units and patient advocacy and charity groups.

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Engineering consultancy supports the transition from initial research to large-scale manufacturing, delivering high-quality, safe and efficient design solutions.

In medical research and pharmaceutical development, the transition from early-stage research to large-scale manufacturing is a key aspect of ensuring equitable access to innovative treatments.

Scaling up pharmaceutical manufacturing

While medical innovation and clinical trial evidence lay the groundwork for developing new therapeutic approaches, scaling up production while maintaining safety, efficacy and regulatory compliance can be challenging.

“The scale-up process is as important as it is complex, and the transition to industrial manufacturing requires extensive input,” explains Aine Dunne, Chief Executive Officer of Process Facilities Group International (PFGi). “Our team, with backgrounds in research, development and scale-up, work closely with pharmaceutical and life science companies to streamline this process.”

Tailored engineering solutions

PFGi is an engineering consultancy specialising in design solutions for complex processes. They help to facilitate the transition from initial research to large-scale manufacturing, supporting pharmaceutical companies, contract research organisations and biotech firms to scale up their production.

“We don’t just size equipment; we collaborate with companies to develop entirely new processes or integrate innovations into existing facilities,” says Dunne. “We don’t expect a fully developed process. Our hands-on approach ensures that companies can adapt to the evolving demands of the industry while maintaining efficiency and regulatory compliance.”

With key services such as equipment selection, process mapping and batch manufacturing, the company actively engages in the developmental process, working alongside clients to refine and optimise their production procedures.

As the industry adapts to develop
more niche and high-cost biotech
drugs, manufacturing is key.

Global pharma manufacturing solutions

Working with life science companies globally to commercialise their manufacturing processes, PFGi has offices in Ireland, Eastern Europe, China, India, North America and South America. “We have worked with a number of companies in the US, commercialising their small-scale laboratory process to reach a wider market,” explains Dunne. “As the industry adapts to develop more niche and high-cost biotech drugs, manufacturing is key. We help companies reduce costs and bring drugs to market faster, minimising capital outlay and providing expert guidance throughout each stage of the process.”

She adds: “Sustainability is a core aspect of engineering in commercial pharma, and our CRP [critical resource planning] and SRP [sustainable resource planning] experts can design efficient systems that minimise water usage, ensure energy systems are appropriately sized and consult on the use of alternative energy sources.”

The company prioritises high-quality, safe and efficient design solutions while building lasting, trust-based relationships for successful project outcomes.

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Professor Karen Boland

Consultant Gastroenterologist, Beaumont Hospital and RCSI

Clinical research centre profiles leading investigators in gastroenterology and infectious disease, whose groundbreaking research is improving patient care and advancing therapeutic discoveries.

Instrumental in delivering the WHO Covid-19 Solidarity Trial in Ireland, Dr Eoghan de Barra leads multiple clinical trials and biobanks focused on emerging infectious diseases, antimicrobial resistance and novel therapeutic interventions for viral and bacterial infections.

Advancing infectious disease research

“My primary focus is expanding Ireland’s participation in large clinical trial platforms, improving access and building capacity,” Dr de Barra explains. “We’re building on post-Covid vaccine work, including mpox vaccination and surrogates of protection while working to integrate Ireland into global initiatives like the SNAP trial to advance immunological and therapeutics research in infectious diseases. All this can be achieved with partners in our new National Infectious Diseases Clinical Trial Network.”

Having a research centre on-site
means I can access clinical space.

Revolutionising gastroenterology research

Leading an active clinical and translational research programme focused on improving outcomes for patients with inflammatory bowel disease (IBD) and liver cirrhosis, Prof Karen Boland’s work is improving treatment response with an emphasis on associated lifestyle interventions.

“We’ve found, by measuring muscle mass in patients with IBD, that those with more muscle are more likely to respond to treatment,” Prof Boland explains. “Our work involves exploring amino acid supplementation, exercise and dietary intervention in IBD and patients with cirrhosis; these data will have a big impact on validating these measures in clinical practice.”

With a large portfolio of work on IBD, Prof Boland also plays a key role in personalising therapeutic interventions. “Although we have treatments for patients with IBD, we don’t have a good understanding of which treatment is best for each patient,” she explains. “We are analysing samples to understand how the microbiome contributes to IBD to identify potential therapeutic targets.”

Clinical research support hub

The RCSI Clinical Research Centre (CRC) provides the facilities and expertise to enable investigators to conduct clinical research to the highest standards, supporting them across a spectrum of clinical areas. “Having a research centre on-site means I can access clinical space for visits with my dietitian, secure storage for patient samples and administrative support for grants and contracts,” Prof Boland explains. “I don’t have protected research time. I have four kids and a busy workload; I lean on a lot of people around me. Without that additional support, this work wouldn’t be possible.”

Dr de Barra agrees: “As a researcher, you don’t have all the answers. It’s important to be able to reach out to experts, discuss challenges and collaborate.”

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Dr Kate Ainscough

Irish Critical Care-Clinical Trials Network Manager

Catherine Guinane

Irish Critical Care Patient and Public Involvement Group (ICC-PPI) Representative

Major trauma is a leading cause of critical illness, often requiring intensive care, organ support and mechanical breathing support, with young adults disproportionately affected.

There is a growing need for effective pharmacological and non-pharmacological therapies which can reduce injury impact and improve recovery and patient outcomes following major trauma. Prof Alistair Nichol, Director of the Irish Critical Care-Clinical Trials Network (ICC-CTN), explains: “Trauma is a major cause of death, often affecting younger patients. Advancements in trauma care will provide huge benefits for families across Ireland.”

Improving treatments for critically ill patients

The ICC-CTN delivers a national portfolio of critical care trials seeking to identify treatments that can improve outcomes for critically ill patients, including trauma patients.

“A key focus of our research is on biological sampling. By examining markers in critically ill patients’ blood, we can predict injury severity and recovery, and identify therapeutic targets,” explains Prof Nichol. “These efforts, plus recent changes within the clinical trials landscape are some ways in which we are advancing research in this space.”

The most important thing is for
patients to be given the best available
treatment at the appropriate time.

New emergency trial status

The new emergency trial status which came into force under the EU Clinical Trials Regulation, means greater access to research than ever before. “Prior to this new regulation, patients who were unconscious were often unable to participate in emergency medication research, but this change opens up new opportunities to advance trauma care for these patients.” Prof Nichol continues: “Our EPO-TRAUMA trial is aiming to enrol 2,500 mechanically ventilated ICU patients following unplanned major trauma and investigate the use of erythropoietin. Where family may not be immediately available to provide agreement to participate, the new regulations allow us to enrol more patients and provide this treatment early, under strict conditions.”

Patient and public involvement

Dr Kate Ainscough, Irish Critical Care-Clinical Trials Network Manager, says: “We know from patient and public involvement (PPI), our public survey, and focus groups, that people are generally in support of alternative consent methods. Our PPI representatives have an important  role in informing our research strategy, and their feedback improves our research process.”

One PPI representative explains: “My involvement in the PPI group makes it so much clearer to me how important it is to get patients involved in trials. I consider the recent changes for trials involving medicinal products a step forward in the right direction. The most important thing is for patients to be given the best available treatment at the appropriate time.” As part of global collaborative efforts, ICC-CTN partners with like-minded research centres on a national and European level to advance trauma care.

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Legislation intended to enhance clinical trial applications needs improvements to better serve patients, says biotechnology company committed to conducting trials in Europe.

With an approach driven by science, leading biotechnology company Regeneron proudly invents, develops and commercialises medicines for people with serious diseases. Founded in 1988 and led by physician-scientists, it expanded internationally in 2013 by opening its European Business office in Dublin, acquiring a site in Raheen, Co. Limerick one year later, which has since been transformed into a major bioprocessing campus.

Digital health to transform clinical trials  

Muriel O’Byrne, SVP of International Regulatory Affairs, discusses how innovative approaches are improving clinical trial outcomes: “Clinical trial execution continues to evolve significantly, thanks to the potential of advancements like digital health technologies and AI. We are keenly interested in the implementation of AI-driven predictive modelling to enhance patient recruitment, optimise trial design, and improve data analysis efficiency while advancements in genetic and biomarker-based approaches are forming the backbone of personalised medicine.”

The biotech company’s unique ability to repeatedly translate science into medicine has led to a wide array of approved treatments and products, most of which were homegrown in their laboratories. Conducting clinical research in around 50 countries globally, Regeneron leads clinical trials across a vast range of therapeutic areas, including ophthalmology, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, haematologic conditions, infectious diseases and rare diseases.

Challenges posed by new EU clinical trial legislation 

Thriving within the biotechnology sector in Europe is currently no easy feat, with the implementation of new clinical trial regulations creating serious hurdles and delays. “One example is the EU Clinical Trials Regulation, passed in 2014 became fully operational this year, which was initially designed to streamline trial applications, and position the EU as an attractive location for continued placement of clinical studies. Unfortunately, in its implementation, it has fallen short of its primary objectives,” says O’Byrne.

Although the application process has been streamlined, it is now resource-intensive from a sponsor’s point of view, with complex requirements, prolonged setup times and increased administrative burden. These ongoing regulatory hurdles are proving challenging. “Authorities who have a seat at the table need to respond to remediate these issues which are reducing the opportunities for patients to access the latest innovations” she adds.

As a result of these regulatory changes, many sponsors are reconsidering their trial strategies, with some shifting their focus to non-EU regions with less bureaucratic regulatory landscapes. “Reports indicate that Europe is losing its share of large-scale clinical studies to Asia and the US, due to these heavy administrative processes and extended startup times. This is a concerning trend for the industry, but it is particularly concerning for patients across the EU who need access to innovative therapies,” she explains.

Reports indicate that Europe is losing
its share of large-scale clinical
studies to Southeast Asia and the US.

A continued dedication to patients 

Despite the ongoing regulatory hurdles, Regeneron remains committed to investing in clinical trials in Ireland and Europe, actively engaging in strategies to address regulatory challenges and maintain its competitive edge.

“It is important that we stay nimble. We have excellent clinical research sites here in Ireland, with committed doctors and good patient access,” says O’Byrne. “We have strong partnerships with major clinical research organisations and institutions and proactively engage to facilitate an attractive EU clinical research ecosystem.”

Ireland’s position as a biopharma innovation hub 

Ireland maintains a strong presence in the global biopharmaceutical sector, with a well-established research infrastructure and an extremely skilled workforce supporting ongoing clinical innovation, strengthening its position as a hub for research excellence despite regulatory challenges.

Regeneron’s Limerick facility is one of the largest-scale biopharmaceutical production sites in Ireland, and it has been pivotal in the company’s production capacity for various therapies. The site has seen continuous investment and expansion, reflecting the company’s commitment to Ireland as a strategic location for its operations. Driven by the pursuit of scientific breakthroughs, it continues to ‘follow the science,’ seeking innovative solutions for people living with serious illnesses.

Date of Preparation: March 2025

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Including patients in clinical trials is critical in developing new, innovative treatments and improving the nation’s health.

Clinical trials and research can be good for the health and wealth of the nation. By participating in a clinical trial, patients may have access to innovative treatments and advanced medical care as well as contribute to medical advancement.

Furthermore, more research-active hospitals can have better healthcare outcomes overall — not only for those participating in the trials. Alongside this positive human health impact, clinical trials and research enhance the value proposition for innovation in Ireland.

How Ireland is advancing clinical trials

Both IPHA and the HSE are of the view that Ireland can play a leading role in the provision of clinical trials in Europe, and in recent times, significant steps have been made in this regard. One such step was Ireland’s decision to join the European Clinical Research Infrastructure Network, which has the potential to widen access to clinical research networks in Europe.

Last year, IPHA and the HSE agreed on a standard Contract Research Organisation (model) Clinical Trial Agreement (CRO mCTA) for use between the Site, the CRO and the Sponsor. The key to the success of the CRO-mCTA is that its standardisation will speed up the process by reducing the administrative and financial burden for the hospitals, CROs and companies. Also, in partnership with the HSE, IPHA launched the updated Bipartite Model Clinical Trial Agreement (CTA) for clinical trials, involving a commercial sponsor and a hospital(s), which supersedes all previous versions of the agreement.

Ireland can play a leading role in the
provision of clinical trials in Europe.

Government backing for clinical trials

From a political level, last July, the Minister for Health established the National Clinical Trial Oversight Group (NCTOG). This group aims to do better for patients by doubling the number of clinical trials taking place in Ireland, and it has already shown a tangible commitment to an improved era for health research.

This was followed by the inclusion in the Programme for Government of a commitment to increase the number of clinical trials and examine how better to support clinicians, researchers and support staff to focus on clinical trial activities.

These steps represent a win for all in the Irish healthcare ecosystem, but most significantly, they will increase the speed at which patients can access lifesaving interventions.

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Clinical trials are essential to establish how well new treatments work and their safety. They are also important for patients to gain early access to new medicines.

Before they begin, clinical trials are approved by regulatory bodies and ethics committees. This is to ensure they are designed to answer a specific research question and that participants in clinical trials are optimally protected.

Clinical trial regulation in Ireland

In Ireland, clinical trials for both medicines and medical devices are assessed and approved by the Health Products Regulatory Authority(HPRA) in collaboration with the National Research Ethics Committees (NREC). For medicines, the process is conducted using a single online platform known as the Clinical Trials Information System (CTIS).

Since 31 January 2025, all ongoing trials have been regulated by the new Clinical Trial Regulation (CTR), which replaced the Clinical Trials Directive (CTD). One benefit of the CTR for patients is the increased transparency of information mandated by the regulation. The CTIS platform also includes a public portal with searchable information for the public.

It is now possible for members of the
public to search for clinical trials that
are running in Ireland and recruiting.

Clinical trial public portal functionality

The portal’s functionality was improved at the end of 2024. The accessibility of the clinical trial information was enhanced; it is now possible for members of the public to search for clinical trials that are running in Ireland and recruiting. Users can also filter to search for clinical trials in a certain therapeutic indication and specific eligibility criteria such as gender or age group. If a clinical trial of interest is found, it is possible to view the ‘location and contact points’ to find out the location and Principal Investigators involved (usually a hospital consultant). The new interactive clinical trials map makes it even easier to search for clinical trials in a particular location.

Improving clinical trial accessibility for Irish patients

As of January 2025, 97 clinical trials are recruiting in Ireland, 45 of which relate to the therapeutic area of cancer. Other common therapeutic areas include cardiovascular diseases (10), and musculoskeletal diseases (4).

Clinical trials in Ireland are run in a wide range of hospitals and primary care settings, including Children’s Health Ireland hospitals, Cork University Hospital, St Vincent’s University Hospital and University Hospital Waterford. It is hoped that CTIS’s new features will help improve the accessibility of clinical trials for patients in Ireland.

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Investment in clinical trials is vital for improving cancer research in Ireland. A centralised funding model can boost research, patient safety and innovation.

A robust investment in clinical trial infrastructure is vital for advancing research and enhancing routine patient care. The current system in the HSE relies heavily on piecemeal funding, often supported by charities, for critical roles like clinical trial nurses, research staff and administrative personnel. This lack of permanent funding undermines job security and hinders the appeal of these roles, making it difficult to attract and retain talent.

Clinical trial support requirements

A fundamental, ongoing financial commitment to integrate clinical trial support into routine clinical care is crucial. Such investment is not merely about improving research outcomes. Embedding clinical trial staff into cancer clinics can significantly enhance patient safety and the quality of routine care. Research nurses, for example, often detect overlooked symptoms or treatment side effects, enabling quicker interventions.

International examples, such as the NHS in the UK, demonstrate the effectiveness of a centralised funding approach. The UK’s National Cancer Research Institute has successfully leveraged national investments to develop robust clinical trial infrastructures, attracting early-phase trials and fostering innovation.

In Ireland, radiotherapy clinical
trials exemplify the potential
of strategic investment.

Radiotherapy trials as an exemplar

In Ireland, radiotherapy clinical trials exemplify the potential of strategic investment. A renewed focus, driven by Cancer Trials Ireland and initiatives like the Irish Radiation Research Oncology Group, has fuelled growth in this area. Investment in clinical fellows and new trial infrastructure at institutions like St. Luke’s has generated innovative, investigator-led projects. Clear, simplified trial designs that target broader patient populations have further contributed to success. However, balancing scientific rigour with recruitment feasibility remains a challenge, particularly for highly specific research questions.

Basic research

Efforts are underway to establish an all-Ireland translational radiation oncology network, uniting preclinical scientific groups across Ireland. This collaboration aims to strengthen laboratory research linked to clinical trials, focusing on blood tests to predict treatment responses and patient follow-ups. By combining fragmented research into a cohesive centre, Ireland could become a standout European hub for translational oncology, ensuring better integration of lab work and clinical practice while driving innovation in radiation research.

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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. 

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