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Irish Health Minister Stephen Donnelly has announced the establishment of a National Clinical Trials Oversight Group. The group will be tasked with developing a strategy to increase the number of clinical trials in Ireland.
The Oversight Group will propose sustainable solutions to improve the efficiency of the clinical trials system, with the aim of enhancing Ireland’s reputation in the clinical trials sector and positioning the country as a strategic host for international clinical trials.
Despite previous political efforts, Ireland still lags behind other European countries in attracting clinical trials.
To address this, Donnelly explained that steps are being taken to improve Ireland’s clinical trial environment. These measures are designed to address existing challenges, including excessive administrative burdens, excess workforce and operational resources, and slow start-up times.
Donnelly said his department had invested more than €150 million in clinical trials and research support services over the past 15 years. The Minister acknowledged that challenges remained and Ireland needed to attract more clinical trials.
Launching the new oversight group, Health Minister Stephen Donnelly TD said: “I want to double the number of clinical trials in Ireland. A strong clinical trials infrastructure leads to better outcomes for patients and, in some cases, saves lives.”
He added: “I would like Ireland to strive to be world-class in hosting more clinical trials, thereby increasing the number of people who can access and participate in clinical trials, with the ultimate goal of achieving better patient outcomes.”
Clinical Trial Market
The difficulties faced by clinical trials in Ireland are not unique. In response to the European Commission’s draft drug legislation proposal last November, Nathalie Moll, director of the European Medicines Agency, said: Effia“We must ensure that this legislation benefits patients and healthcare systems, and we must also halt and reverse the downward trend in European R&D investment, the number of clinical trials and medicines manufacturing,” he said.
The European Medicines Agency (EMA) approves approximately 4,000 trials in the European Economic Area (EEA) each year. However, drug development is a long and expensive process, taking an average of 12 years to gain patient approval; clinical trials represent 50% of the total cost of a drug, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). Average 58.6% Total product development cost.
Despite the current challenges, Market Research Future reports that European clinical trial market size Valued at $13.73 billion in 2023, it is “expected to grow from $14.38 billion in 2024 to $23.57 billion in 2032, at a compound annual growth rate (CAGR) of 5.64% during the forecast period (2024-2032).”
The global clinical trial market size is valued at USD 80.7 billion in 2023.
Center for Health Policy Clinical Trials
“Creating a cohesive, lean, innovative clinical research environment will also enable us to attract the best doctors, nurses, engineers and scientists to work in Ireland and hopefully put research at the centre of health care policy in the future,” said Professor Donald Brennan, Chair of the National Clinical Trials Oversight Group.
Eimear O’Leary, Director of Communications and Advocacy at the Irish Pharmaceutical and Healthcare Association (IPHA), said: “IPHA warmly welcomes the recent announcement by Health Minister Stephen Donnelly of the establishment of a new National Clinical Trials Oversight Group.”
“We also welcome Dr Caitriona Walsh to the group, who will be the voice of IPHA. Caitriona is General Manager and Country President of Novartis Ireland Innovative Medicines and Chair of IPHA’s Clinical Research Communication Group.”
O’Leary added: “We look forward to hearing about the practical outcomes of the group’s work, which will significantly increase the number of clinical trials available to Irish patients in need.”
National Clinical Trials Oversight Group
Ireland’s National Clinical Trials Oversight Group is expected to strengthen the country’s clinical trials capacity and international research reputation. By coordinating industry-sponsored and academic-led trials, the group aims to drive research and innovation, ultimately improving clinical outcomes.
The oversight group is expected to run for one year and has outlined key deliverables aimed at improving the clinical trial environment. These include an interim report on the challenges of conducting clinical trials, a final report proposing solutions, and promoting a standardized approach among stakeholders to ensure efficient business processes and reduce administrative burdens.
The group is also working to establish a single validated database to assist in policy development and development in the clinical trials field.
The group will be linked to the EU/EEA clinical trial information system. From January 31, 2023, all initial clinical trial applications in the EU/EEA must be submitted via the Clinical Trial Information System (CTIS).
Clinical Trial Information System
The EU’s Clinical Trials Regulation aims to streamline the assessment and oversight of trials, a responsibility that was previously split between the EU and EEA countries.
Before the promulgation of this regulation, clinical trial sponsors had to submit clinical trial applications to the national competent authorities and ethics committees of each country to obtain approval from the regulatory authorities to conduct clinical trials.
The regulation allows sponsors to submit one online application for approval to conduct clinical trials in multiple European countries through a single online platform called CTIS, thereby increasing the efficiency of conducting such multinational trials.
Its overall aim is to promote innovation and research, thereby enabling larger clinical trials to be conducted across multiple EU and EEA countries.
(By Brian Maguire | Euractiv Promotional Lab ）
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