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|Key Milestones and Achievements 2007-2010|
|ICRIN Goals and Next Steps - Implementation Phase - 2011 and 2012|
|ICRIN Working Group|
ICRIN foundation members 2006- Professor Terry Smith and Professor Tim O’Brien, NUI Galway, Professor Brian Harvey RCSI, Dr Pierre Meulien, CEO Dublin Molecular Medicine Centre, Professor Bill Powderly, UCD, Professor Peter Kennedy, Professor Eamonn Quigley and Professor Fergus Shanahan, UCC, Professor Jim Browne, NUI Galway, Professor Dermot Kelleher, TCD, Professor Nicholas Canny, NUI Galway
The MMI partners created the Irish Clinical Research Infrastructure Network (ICRIN) to engage with the constituent teaching hospitals to develop a national clinical research infrastructure, to harmonise clinical research processes, to connect with European networks, to develop education and training programmes and to support investigators in conducting multi-centre clinical studies. The work of ICRIN complements the investment by the Health Research Board (HRB) and the Wellcome Trust in clinical research facilities and personnel in Dublin, Cork and Galway since 2007.
ICRIN was formed in 2006 by University College Dublin (UCD), Trinity College Dublin (TCD), University College Cork (UCC), National University of Ireland, Galway (NUIG) and the Royal College of Surgeons in Ireland (RCSI) and operates as a business unit of Molecular Medicine Ireland (MMI). Since 2007, the work of ICRIN has been funded by the HRB and the Health Service Executive (HSE). In 2008 Enterprise Ireland provided funding to Molecular Medicine Ireland (MMI) to provide a Clinical Trial Liaison Officer (CTLO) to build on linkages between Ireland’s lifescience industry and the clinical research system
Through ICRIN, the clinical research community in Ireland is working together to a common strategy, adopting harmonised processes and practices and fostering education and training in all aspects of clinical research in order to support academic and industry sponsors of research, particularly multi-centre studies. ICRIN, as the Irish member of the European Clinical Research Infrastructure Network, forms part of a European-wide effort to construct an infrastructure for multi-centre and multi-national clinical trials sponsored by academic institutions and SMEs.
In February 2009, ICRIN launched its training programme in Good Clinical Practice (GCP) to ensure that all those involved in clinical research had access to training of the high standard required for the conduct of clinical research. By the end of 2010, 132 clinical researchers had completed ICRIN GCP courses and the demand for places remains as strong as ever. In 2008, ICRIN supported the re-launch of the Irish Research Nurses Network and worked closely with the Dublin Centre for Clinical Research in the launch of the RCSI Certificate course in research nursing.
In April 2009, ICRIN published the Clinical Research Irish Situation Analysis which is the first overview of the status of all types of clinical research, the regulations governing the conduct of such research and the supporting infrastructure. The Situation Analysis is a resource for those involved in clinical research and those trying to understand how the regulatory, ethical, safety and quality requirements operate in this country.
In April 2009, ICRIN and the State Claims Agency organised a workshop that clarified key aspects of provisions for the indemnity of clinical research for those involved in clinical research.
Clinical Research Roadmap
In response to the need to develop a strategic approach to the development of clinical research in Ireland, ICRIN convened key players in a series of workshops to analyse the current situation of clinical research and agree comprehensive recommendations for the way forward. Following widespread consultation, ICRIN prepared the Clinical Research Roadmap. The Roadmap highlights the strategic and operational changes needed to improve Ireland’s capacity to undertake high quality, multi-centre clinical research support the development of new medicines, diagnostics, therapeutics and medical devices and to allow Ireland participate more actively in European clinical research initiatives. The Roadmap was launched by the Minister for Health and Children in June 2010 as part of a wider government initiative to make Ireland a leading country for the conduct of clinical research, both academic and industry sponsored.
Assisting SMEs and Start-ups access clinical resources
In April 2009, Enterprise Ireland awarded MMI and ICRIN funding to develop a service to assist SMEs and start-ups access clinical resources and navigate the regulatory maze in order to commercialise their products. In the period to the end of 2010, 52 companies were assisted, of which 10 were engaging in clinical trials.
Research Readiness Programme
In January 2010, ICRIN launched the Research Readiness Programme with a selected number of research institutions, clinical research centres and their associated researcher teams in Ireland. The overall goals of the Research Readiness Programme are to evaluate in more detail the research processes that are already functioning well, identify the areas where more consistency of approach would be of benefit, provide encouragement to share best practice and gain information from the research teams on the research infrastructure elements which would be best addressed at a national level.
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Following the publication of the Clinical Research Roadmap in June 2010 MMI, ICRIN and the HRB engaged in discussions about the next steps in the progression of the clinical research infrastructure agenda in Ireland. The Government’s Action Plan for Health Research (2009) and the Strategic Business Plan of the Health Research Board identified the development of excellent clinical research within a coherent health research system as one of four goals in the period to 2014. All parties recognised the need to align their respective work programmes. In October 2010, ICRIN was awarded additional HRB funding to 2012 to maintain the momentum for harmonisation of research at a national level and to focus on developing the foundations for a national coordinating centre for clinical research.
The award was based on three key work elements:
- The first is a more detailed review of the state of Research Readiness within the currently funded research infrastructure elements, including the CRCs in Dublin, Cork and Galway as well as in other research institutions.
- The second is the development of an initial core of harmonised processes and tools across the existing research entities. This initiative would take advantage of existing best practice with the CRCs/research units and research networks, identify and prioritise the development of any missing processes and guidance for research and enable national access for the entire research community. Continuation of the Good Clinical Practice and good research practice training and education of those engaged in the hands on delivery of clinical research is to be maintained in this next work plan.
- The third is a scoping of a cohesive national coordinating system for research, incorporating the lessons learned from the experiences of the existing CRCs and fit for purpose for a future sustainable research support system in Ireland.
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Siobhan Gaynor (Programme Manager- Clinical and Translational Research)
Susan Lennon (Clinical Research Manager)
Dr. Suzanne Bracken (Programme Officer- Translational Research)
Fionnuala Gibbons (Clinical Trials Liaison Officer)
Siobhan's role as Programme Manager –Clinical and Translational Research is to facilitate clinical investigators in conducting multi-centre clinical studies at a national and European level, to position ICRIN as the national coordinating body for clinical research in Ireland and to build capacity for translational research through collaborative initiatives in relation to biomarker discovery and validation, research technologies, biobanking and other relevant activities. In addition to her responsibility for directly managed resources, Siobhan works with clinical and translational personnel in the MMI partner institutions to maximise the return from the commitment to collaboration represented by MMI.
Siobhan joined ICRIN/Molecular Medicine Ireland from the all-Ireland Cooperative Oncology Research Group (ICORG) where she was Quality and Training Manager. ICORG is the Cancer disease network in Ireland. Siobhan has over 18 years experience in clinical trials, in industry, academia and in the contract research sector.
Siobhan is an experienced Good Clinical Practice trainer and auditor and has experience of monitoring and managing multinational trials in a number of disease areas. Siobhan has also worked as a research pharmacologist in the UK for a multinational pharmaceutical company.
Siobhan is a graduate of Trinity College Dublin and has a degree in Physiology.
Susan Lennon has over 20 years experience in the pharmaceutical industry and, in particular, in the implementation of clinical trials within contract research organisations (CROs).
Susan has also held a number of senior positions in customer relationship management, negotiating with both customers and internally on behalf of the customer to enable the timely delivery of high quality clinical trials. Susan holds a Masters in Biotechnology, a BSc in Microbiology/Biochemistry and a Diploma in Computers and in Management, all from UCC. Susan held roles initially in a veterinary pharmaceutical company within the areas of clinical trial design and regulatory affairs. She then moved to the CRO industry where she worked in the management of data management and laterally as European Head of Pharmacovigilance with responsibility for the implementation of the Clinical Trial Directive and electronic reporting.
Dr Suzanne Bracken is the Programme Officer for Translational Research at Molecular Medicine Ireland (MMI) where her responsibilities are to develop and deliver the work programme for translational research, as part of the ICRIN (Irish Clinical Research Infrastructure Network) team. Activities include the coordination of the Irish Biomarker Network and the MMI Biobanking Group.
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Fionnuala is the Clinical Trial Liaison Officer, within the Irish Clinical Research Infrastructure Network (ICRIN), which is hosted by Molecular Medicine Ireland (MMI). Fionnuala is responsible for the development of clinical research process knowledge and awareness among indigenous and multi-national pharmaceutical, medical device and biotechnology companies. This post is being funded by Enterprise Ireland .
Fionnuala has a wealth of experience in clinical research across the pharmaceutical industry. She initially began her career as a nurse, finishing as a theatre and anaesthetic sister in Charing Cross Hospital, London, and then transitioned to clinical research working as a Research Coordinator in the Thrombosis Research Centre in Kings College Hospital, Clinical Research Associate in PPD Contract Research Organisation in Cambridge and Senior Clinical Monitor/Project Manager in Bristol-Myers Squibb (BMS), Dublin. Fionnuala has worked across a variety of therapeutic areas including cardiology, oncology, haematology, rheumatology, endocrinology, psychiatry, CNS and HIV. Prior to joining MMI, Fionnuala held the position of Oncology Scientific Advisor for sanofi-aventis.
The ICRIN working group was set up to undertake the implementation of the ICRIN work plan and to address a priority set of issues related to the implementation of mulitcentre trials at a granular level.
The ICRIN Working Group chair is Professor Patrick Murray in his capacity as the ICRIN Clinical Director. The members of the ICRIN Working Group come from all partner institutions and are as follows:
|Prof. Dermot Kenny||RCSI|
|Prof. Martin O'Donnell||Galway|
|Aideen O' Doherty||NUIG|
|Prof. Patrick Murray||UCD/ICRIN|
|Dr. Peter Doran||UCD|
|Prof. Frank Giles||NUIG/TCD|
|Prof. Michael Gill||TCD|
|Dr. Joe Eustace||UCC|
Additional sub-teams will be formed to address other elements of the work plan. Please contact Siobhan Gaynor, Programme Manager of Translational and Clinical Research at firstname.lastname@example.org if you are interested in participating .
ICIRN Quality Management Sub Team
This team formed in December 2010 to address the Quality Management, Process Harmonisation and associated reseach training needs and to review the ICRIN work plan deliverables. As a result of the work of this group 37 templates, standards and guidance documents on drug clincial trials have been produced and are available in the IMP section of the ICRIN web portal.
First meeting of the ICRIN QM subgroup in the snow in Dec 2010
Quality Management Sub-team Members
|Emma Deenihan||NUI Galway- CRFG|
|Jennifer Feighan||FP7 Programme Manager|
|Siobhan McCoy||Our Lady's Children's Hospital, Crumlin|
|Mary McGrath||UCD/ St. Vincent's CRC|
|Veronica McInerney||NUI Galway- CRFG|
|Ann Marie Mulligan||Mater Hospital|
|Sinead Nally||National Children's Research Centre|
|Siobhan O' Daly||Irish Heart Foundation|
|Gloria Crispino O' Connell||Statistician|
|Aideen O' Doherty||NUI Galway- CRFG|
|Jeremy Towns||DCCR/ MMI|
|Elizabeth Tully||Perinatal Ireland|
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