Ireland launches new clinical trials oversight group to attract pharma investment [Advocacy Lab Content]

Ireland’s Minister for Health, Stephen Donnelly, has announced the formation of a National Clinical Trials Oversight Group. The group is tasked with developing strategies to increase the number of clinical trials conducted in Ireland.

The Oversight Group will propose sustainable solutions to create efficiencies in the clinical trials system, aiming to enhance Ireland’s reputation in the clinical trials landscape and positioning the country as a strategic host for international clinical trials.

Despite previous political efforts, Ireland lags behind other European countries in attracting clinical trials.

To address this, Donnelly explained that steps are now being taken to improve the clinical trial environment in Ireland. These measures aim to tackle existing challenges, including excessive administrative burdens, workforce and operational resources, and slow start-up speeds.

Donnelly said that over the past 15 years, his department has invested over €150 million in clinical trials and research support services. The Minister acknowledged that challenges remain and that Ireland needs to attract more clinical trials.

Establishing the new oversight group, Minister for Health, Stephen Donnelly TD said: “I want to double the number of clinical trials taking place in Ireland. A strong clinical trial infrastructure can give patients access to treatments that deliver improved outcomes and, in some cases, can be lifesaving.”

He added: “I want to see Ireland aim for best in class globally in terms of hosting more clinical trials, thereby increasing the number of people who can access and participate in clinical trials with the ultimate objective of achieving better patient outcomes.”

Clinical trials market

Ireland’s clinical trials struggle is not unique. Responding to the European Commission’s draft Pharmaceutical Legislation proposals last November, Nathalie Moll, Director General, EFPIA, said: “We have to make sure that the legislation works for patients and healthcare systems, and we must also stop and reverse the downward trends in Europe’s research and development investment, numbers of clinical trials and medicines manufacturing.”

The European Medicines Agency (EMA) authorises approximately 4,000 trials annually across the European Economic Area (EEA). However, medicine development is a lengthy, costly process, taking an average of 12 years for patient approval; according to EFPIA – the European Federation of Pharmaceutical Industries and Associations – clinical trials represent on average 58.6% of a product’s total development costs.

Despite current challenges, Market Research Future reports that the European clinical trials market size was valued at USD 13.73 Billion in 2023, “and is projected to grow from USD 14.38 Billion in 2024 to USD 23.57 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.64% during the forecast period (2024 – 2032).”

The global clinical trials market size was valued at USD 80.7 billion in 2023.

Clinical trials at centre of health policy

“The development of a cohesive, lean, innovative clinical research environment will also allow us [Ireland] to attract the most talented doctors, nurses, engineers, and scientists to work in Ireland and hopefully place research at the centre of health care policy in the future,” said Professor Donal Brennan, Chair of the National Clinical Trials Oversight Group.

Eimear O’Leary, Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association (IPHA) said: “IPHA warmly welcomes the recent announcement by Minister for Health, Stephen Donnelly in relation to the establishment of a new National Clinical Trials Oversight Group.”

“We also welcome the inclusion of Dr Caitriona Walsh on this group who will represent the IPHA voice. Caitriona is Managing Director of Innovative Medicines and Country President at Novartis Ireland and Chairs IPHA’s Clinical Research Exchange Group.”

O’Leary added: “We look forward to hearing the practical outcomes from the work of this group which should result in a significant increase in the number of clinical trials available to Irish patients who need them.”

National Clinical Trials Oversight Group

The National Clinical Trials Oversight Group in Ireland is expected to bolster the nation’s clinical trials capability and international research reputation. By coordinating industry-sponsored and academically led trials, the group aims to drive research and innovation, ultimately leading to improved clinical outcomes.

The Oversight Group, expected to operate for a year, has outlined key deliverables aimed at enhancing the clinical trials landscape. These include an interim report on the challenges of conducting clinical trials, a final report proposing solutions, and the facilitation of a standardised approach among stakeholders to ensure efficient business processes and reduced administrative burdens.

The group also aims to progress towards a single verified database to aid policy formulation and development in the clinical trial landscape.

The Group will dovetail with the EU/EEA’s Clinical Trials Information System. Since 31 January 2023, all initial clinical trial applications in the EU/EEA have to be submitted through the Clinical Trials Information System (CTIS).

Clinical Trials Information System

The EU’s Clinical Trials Regulation aims to streamline the assessment and supervision of trials, a responsibility previously shouldered separately by each EU and EEA country.

Before the Regulation was enacted, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.

The Regulation enables sponsors to submit one online application via a single online platform known as the CTIS for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.

Its overarching goal is to foster innovation and research, enabling larger clinical trials across multiple EU and EEA countries.

[By Brian Maguire | Euractiv’s Advocacy Lab ]

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