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Enabling Clinical and Translational Research

Overview


Molecular Medicine Ireland has an established national clinical research programme that began in 2006. 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. 

 

 

Overview

Clinical research tries to discover ways to improve the prevention, diagnosis and treatment of disease and the quality of life of patients. Clinical researchers work together in a multi-disciplinary manner to translate scientific advances in the laboratory into better outcomes for patients and improved health of the population. They in turn use their clinical insights to inform the questions addressed by scientists in the laboratory. Patients and healthy volunteers, through their participation in clinical studies and the donation of samples for molecular research, play a key role in clinical research and make an immense contribution to efforts to understand the mechanisms of disease and improved patient outcomes into the future. The knowledge gained from clinical research can then be applied to improve the efficiency and effectiveness of health professionals and the health care system at a national or international level and to improve the health of citizens as a whole.

There are great opportunities for clinical research in Ireland – we have patients and volunteers willing to participate in studies to prevent and treat disease more effectively and we have highly trained physicians, surgeons and nurses committed to advancing knowledge and improving outcomes for patients.

  

The diagram illustrates the virtuous circle for medical advances that is created when clinical and laboratory-based academic research are aligned and working closely together.

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Why does Ireland Need Clinical Research Infrastructure?

To support clinical research and researchers to conduct their studies to the highest international standards of efficiency and ethical principles, a national research infrastructure is required that is fit for purpose for each country. The Irish clinical research infrastructure needs to be appropriate to national research requirements but must also be consistent and competitive with the research infrastructures in other countries in order to ensure Irish investigators can lead European and international studies and that Ireland is a preferred country in which multinational companies can perform their research programmes.
An effective research infrastructure should be organised so that it improves all processes related to the design, approval, start-up, enrolment and completion of clinical trials and other research programmes with a measurable impact on productivity and research outcomes for industry and academic driven research programmes.

We need clinical research because:

1. Patients and the general public are the primary beneficiaries of clinical research – they benefit from new understandings of disease, new vaccines, new diagnostics, new therapies and medical devices. In that sense, today’s health research is tomorrow’s healthcare.
2. Clinical research is helping to build Ireland’s reputation for high quality research and science. It is adding to the reputation of our universities, medical schools and hospitals for scientific excellence and contributing to the teaching and learning environment.
3. In this way, clinical research addseconomic value, creates jobs and contributes to the creation of the knowledge economy.  

  

Figure legend: Core clinical research infrastructure needs by Small to Medium Enterprises (SME’s), Investigator driven research and Industry sponsored research
Ireland’s size can offer a competitive advantage in that it is easier to establish the initial core infrastructure via the integration of the key academic sites though the networking of their CRCs, which then work jointly on clinical trials with hospital and community-based health care providers.

The hospitals and other care providers complete the infrastructure by providing access to large numbers of well-characterised patients. MMI and ICRIN currently provide the forum for this phase of infrastructural development as the partners are the five academic medical institutions, which together with their affiliated hospitals and the established and emerging CRCs, are leading  clinical and translational research in Ireland.

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What is an Infrastructure for Clinical Research?

A clinical research infrastructure comprises the buildings, people and supporting structures and processes that enable a functioning clinical research system. The infrastructure must provide a core foundation of supporting logistics to facilitate the integration of the various partners in the research process – government, scientists and academics, clinicians and hospital research teams (nurses, pharmacists, and laboratory staff) and industry.
The European Clinical Research Infrastructure Network (ECRIN), of which ICRIN is the Irish partner, describes this infrastructure as comprising three core elements adapted appropriately to each country to support translational and clinical research:
 
1.      Clinical Research Centres (CRCs) that are the local infrastructures providing support and services to clinical studies by way of:
  • Clinical infrastructure such as dedicated beds, equipment, or specialised staff (study nurses, etc)
  • Trial or study management (clinical trial or research units): trial design and operational methodology, randomisation, data management, analysis and reporting
  • Facilitating Study Sponsorship: interaction with ethics committees and competent authorities, adverse event reporting, quality assurance and monitoring.
2.      National clinical research networks that are the harmonised country networks of CRCs, clinical trials units and/or disease-oriented networks, reaching the critical mass and representing the standard in its country, with the ability to provide support to any category of clinical research, in any disease area.
3.     A national clinical research hub which is the co-ordinating centre for the national network

Clinical Research in Ireland

The Government’s Strategy for Science, Technology and Innovation 2006-2013 recognised  the need to 'upgrade existing infrastructure and develop new facilities to support research’. Under the Strategy, major investment is taking place to provide an infrastructure for clinical research.

Approximately €54 million from public and philanthropic sources will be invested over the next five years to provide facilities, networks, trained staff, shared processes, standards and information technology systems which will greatly increase national capacity to undertake clinical research.

Key Investments in the Irish Clinical Research Infrastructure to date:

The HRB, HSE and Higher Education Authority (HEA) have invested in building clinical research expertise through support for clinician scientists as joint appointments to academic institutions and hospitals and fellowships to train, in Ireland, the next generation of clinical investigators.

The Dublin Centre for Clinical Research (DCCR) is a successful collaboration between TCD, UCD, RCSI and MMI that succeeded in securing a competitve funding award from the Wellcome Trust and the HRB. Under this initiative, the Wellcome Trust is funding TCD to build a new CRC on the campus of St James’s Hospital and the HRB is funding the development of a clinical research network in Dublin, linking the UCD CRC at St Vincent’s University Hospital and the Mater Misericordiae University Hospital, the RCSI CRC at Beaumont Hospital and TCD’s planned CRC in St James’s Hospital, all of which form  the DCCR Clinical Research Network.   Several Disease Networks have been formed across Dublin and these are undertaking collaborative city-wide clinical research studies. MMI is playing a key role in the development of the DCCR Network.

The HRB has also funded new CRCs at University College Hospital Galway and University College Cork in their associated academic hospitals.

The Centre for Advanced Medical Imaging (CAMI) at St. James's Hospital Dublin has been funded through a HRB research infrastructure call as a national resource for clinical and translational research. The grant was awarded in response to a proposal by clinical and scientific investigators at St. James's Hospital and TCD to develop a clinical human imaging research centre with an initial focus on MRI. Following a tender process, a Philips 3T Achieva MRI was chosen as the first CAMI imaging modality. A new building required to house CAMI on the hospital campus and the facility opened in 2008 with an initial focus on research in the cardiovascular, neurology and oncology areas. It is located beside the planned HRB/Wellcome Trust CRC, described below.

The HRB has funded an innovative research project in Beaumont Hospital to develop an electronic record for patients with epilepsy, that is improving the delivery and quality of care to over 3,000 patients attending the national centre for the treatment of this disorder and which has a strong research focus. The challenges of creating the e-record have been overcome and by January 2010 the records of over 1000 patients had migrated to the new system, with significant improvements noted in the effectiveness and quality of care provided to patients. The electronic records are also providing a valuable resource for investigators engaged in epilepsy research and they are facilitating a much quicker identification of patients suitable for participation in studies of new therapies and of genetic factors associated with the disorder. The epilepsy e-record provides a model for adoption throughout the health service for improved clinical care and as a resource for clinical research.

The Centre for Support and Training in Analysis and Research (CSTAR), based in UCD, is an additional infrastructure element funded by the HRB to strengthen research quality by providing advice, consultancy, training and education in research methodologies, study design, project management, analysis, reporting, appropriate dissemination to inform practice and other support services. CSTAR began offering research support services in 2009.

The Minister for Health and Children and the State Claims Agency have provided a supportive regime for the indemnity of those involved in clinical research in public hospitals and associated CRCs, and the current medical consultant contract includes provision for clinicians to dedicate more time to clinical research, with the agreement of their clinical director.

The HRB, the Health and Social Care Research and Development Office (HSC R&D Office) in Northern Ireland and the Irish Cancer Society have supported the development of the Irish Clinical Oncology Research Group (ICORG) to support clinicians, scientists and hospitals on an all-island basis in the conduct of high quality studies to improve the treatment of cancer. ICORG has demonstrated the value of an all-island coordinating organisation for clinical research in cancer. The HRB and the Irish Cancer Society have supported the Prostate Cancer Research Consortium which is a network of clinicians and scientists across Dublin mandated to develop a biobank of patient tissue and samples for research on prostate cancer and a sophisticated clinical informatics system to maximise the value of the information collected.

The HRB and HSE  funded ICRIN to engage with the CRCs, medical schools and constituent teaching hospitals to develop the ‘soft’ infrastructure for clinical research in Ireland, that is, to harmonise standards and processes, to address deficits in education and training, to facilitate multi-site studies across a range of diseases and, through consensus, recommend solutions to common problems.

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