Minister for Health announces the establishment of a new National Clinical Trials Oversight Group to improve access for patients

Minister for Health, Stephen Donnelly has announced the establishment of a National Clinical Trials Oversight Group which is tasked with developing recommendations to increase the number of trials taking place in Ireland. The first meeting of the group took place today.

Clinical trials are a fundamental component in enabling high-quality care and improving patient outcomes.

The National Clinical Trials Oversight Group will propose sustainable solutions, with a view to creating more efficiencies in the clinical trials system. This will ensure Ireland can build on its excellent reputation across the clinical trials landscape and further position the State as a key strategic host in attracting international clinical trials.

At present, Ireland is not attracting as many clinical trials as some other European countries. National initiatives have been implemented and additional steps are being taken to address this and improve the clinical trial landscape in Ireland. Solutions are required to address challenges that remain, including, the excessive administrative burdens, workforce, and operational resources, as well as slow start-up speeds.

Establishing the new oversight group, Minister for Health, Stephen Donnelly TD said:

"Clinical trials are a fundamental component of high-quality care and improving patient outcomes. Over the last 15 years, my Department has invested more than €150 million in clinical trials and research support services. Good progress has been made in improving the clinical trials landscape in Ireland, but challenges remain. Ireland is not attracting as many clinical trials as some other European countries. We need to do better for patients. 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. I want to see Ireland aim for best in class globally in terms 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.

“I have established the National Clinical Trials Oversight Group to propose tangible, innovative solutions. Improvements have the potential to make an enormous difference to patients. I would like to thank the Chair, Professor Donal Brennan, and all the members of the group, , for their commitment in progressing the important work of this Group. The work of the Oversight Group will be a vital contribution to the improvement of Ireland’s clinical trials landscape.”

Chair of the National Clinical Trials Oversight Group, Professor Donal Brennan, said:

“I am honoured to chair this Oversight Group. There is now irrefutable evidence that increased research activity correlates with improved clinical outcomes across multiple healthcare systems, particularly when patients participate in clinical trials. I hope that this Group can work together to make Ireland a destination of choice for clinical trials, whereby patients can access new medicines and technologies in a safe, efficient, ethical and transparent fashion. The development a cohesive, lean, innovative clinical research environment will also allow us 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”.

Notes to Editor:

National Clinical Trials Oversight Group

Membership

Professor Donal Brennan has been appointed Chair of the National Clinical Trials Oversight Group. The wider group has representation from a range of fields, including clinical settings, policymaking, academia, research ethics, and industry.

Name	Role and Organisation
Prof Donal Brennan (Chair)	Professor of Gynaecological Oncology, University College Dublin (UCD). Gynaecological Oncologist, Mater Hospital.
Prof Alistair Nichol	Chairperson, National Research Ethics Committee for Clinical Trials. Professor Of Critical Care Medicine, University College Dublin. Director, Irish Critical Care-Clinical Trials Network. Consultant Anaesthetist and Intensivist, St Vincent’s University Hospital.
Dr Ana Terres	Assistant National Director, Head of Research and Evidence, Health Service Executive (HSE).
Dr Caitriona Walsh	Board of Directors, Irish Pharmaceutical Healthcare Association, Managing Director Innovative Medicines and Country President, Novartis Ireland.
Prof Fidelma Dunne	Professor in Medicine, University of Galway.Consultant Endocrinologist, Galway University Hospital.
Dr Finnuala Lonsdale	Director Human Product Authorisation and Registration, Health Products Regulatory Authority (HPRA).
Ms Lucy Nugent	CEO, Tallaght University Hospital.
Dr Mairéad O'Driscoll	CEO, Health Research Board (HRB).
Prof Martina Hennessy	Clinical Pharmacologist and Consultant Physician, St James’s Hospital. Director, Wellcome Health Research Board (HRB)-Clinical Research Facility, St James’s Hospital. Associate Professor in Medical Education, Trinity College Dublin (TCD). Deputy Chair, Health Research Board (HRB) Clinical Research Coordination Ireland (CRCI).
Mr Muiris O'Connor	Assistant Secretary General, Research and Development and Health Analytics, Department of Health.
Prof Paul McNally	Associate Professor of Paediatrics, Royal College of Surgeons Ireland (RCSI). Director of Research and Innovation, Children’s Health Ireland (CHI) Crumlin.
Prof Peter Doran	Director, University College Dublin (UCD) Clinical Research Centre. Professor of Clinical Trials, University College Dublin (UCD) School of Medicine.
Dr Robert O'Connor	Director, Health Research Board (HRB) National Clinical Trials Office.
Ms Rose Kidd	President, Operations Delivery, ICON Plc.
Prof Seamus O'Reilly	Consultant Medical Oncologist, Cork University Hospital Clinical Lead, Cancer Trials Ireland.
Ms Simone Walsh	Programme Manager, Irish Research Nurses and Midwives Network. Activation Manager, Royal College of Surgeons Ireland (RCSI) Clinical Research Centre.
Ms Siobhán Gaynor	Patient and Public Involvement representative.
Ms Vicky McGrath	CEO, Rare Diseases Ireland.

Purpose and Objectives:

The purpose of the National Clinical Trials Oversight Group is to support the delivery of a nationally coordinated approach to the management of clinical trials, from industry sponsored to academically led, to improve Ireland’s national clinical trials landscape and international reputation as a hub for clinical research. The ultimate ambition is to enhance and improve the efficiency of the Irish clinical trials landscape to drive further research and innovation which can lead to improved clinical outcomes.

It will achieve this through the following objectives:

1. Identify obstacles and challenges facing patients, translational scientists, doctors and healthcare management in Ireland who wish to participate in clinical trials.

2. Identify obstacles and challenges facing sponsors seeking to conduct clinical research in Ireland - explore perceived barriers/factors considered suboptimal for industry and international sponsors considering Ireland as a destination for clinical research.

3. Outline proposals to address the obstacles and challenges identified.

Recommend actions and where appropriate convene subgroups to consider relevant solutions.

4. Streamline, simplify and harmonise the process of completion of clinical trial contracts and data protection agreements to improve efficiency and allow clinical trials to open in a timely cost-effective fashion.

5. Optimise the use of data pertaining to clinical trials with the view to collating a holistic viewpoint of the clinical trials landscape to enhance Department of Health policy decision making.

Deliverables:

Key deliverables for the Oversight Group include:

1. Produce an interim report outlining the challenges involved in conducting clinical trials.

2. Deliver a final report detailing potential solutions to enhance the clinical trials landscape.

3. Facilitise a standardised approach across all relevant stakeholders in the area of clinical trials, to ensure agreed efficiencies across business processes, i.e. reducing the administrative burdens.

4. Enable progress towards achieving a single verified database that enhances formulation of policy and development of the clinical trial landscape.

It is envisioned that the Oversight Group will be operational for a period of one year.

Clinical Trials in Ireland

Over the last 15 years, the Department of Health has made significant investment in clinical trials infrastructure and research support services. This investment has resulted in the establishment of state-of-the art clinical research facilities on the campuses of hospitals; clinical trial networks to support the conduct of multi-centre trial and interventions studies; and a National Clinical Trials Office for those involved in Clinical Trials, including industry.
Ireland has made some important developments in improving the clinical trials and health research landscape, including the establishment of the National Office for Research Ethics Committees for regulated clinical trials.
In 2018, Ireland became a member of the European Clinical Research Infrastructure Network (ECRIN). ECRIN membership enables increased access for Irish patients to multi-national clinical trials and makes it easier for Irish researchers to extend their own trials internationally.