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HRB-Clinical Research Coordination Ireland Phase II Programme

Vision for HRB CRCI:
“That Ireland is internationally recognised for conducting innovative high quality clinical research for the benefit of people’s health and the economy.”
The vision of HRB CRCI remains unchanged from Phase I.
HRB CRCI’s Mission:
“To advance healthcare by coordinating and enabling an integrated system of Irish Clinical Research Facilities and Centres with the specialist skills, expertise and infrastructure to design, conduct and analyse clinical trials and other complex studies, undertaken by networked clinician investigators and/or industry.”
We adjust slightly our mission statement in order to emphasise that the HRB CRCI role is predominantly one of research facilitation and enabling at the centre level rather than at an individual project level. This avoids any confusion (or potential competition) between the proposed role of HRB CRCI and that of the component CRF/Cs within the network. We clarify that in keeping with its approved name HRB CRCI will focus on both clinical trials and other complex studies. Strategic Objectives (1-3 yr)
1. Build on the success to date of HRB CRCI and MMI, its partner institutions and affiliated hospitals in developing and enabling an integrated Irish clinical research environment. 2. To continue to serve as the central point of contact for trial related activities In Ireland, representing and promoting Irish research at national and international fora and stakeholder conferences and providing ‘horizon scanning’ for potential opportunities or challenges. 3. Providing generic advice and guidance to potential sponsors, funders and investigators on establishing and conducting research in Ireland and conecting them with the available supports and resources available within the irish academic research environment.
4. To support and assist in the design, grant submission, set-up and conduct of multicenter investigator initiated trials and to coordinate and facilitate the provision of specialist clinical trial services, to identify gaps in the above services and as appropriate support the development of missing services either centrally or at a partner institution(s).
5. To ensure the conduct of studies to a uniform high standard in keeping with international best practice and regulatory, legal and ethical requirements, thereby facilitating multicentre projects while protecting the rights and well-being of study subjects and integrity of study data. 6. Enhance the successful conduct of clinical trials by supporting preliminary feasibility and recruitment potential assessments, project approvals and site set up, for both academic and commercial multi-centre trials and complex studies; to identify existing barriers to the efficient and timely completion of these tasks and oversee a coordinated response to address such deficiencies.
7. To identify, endorse and support the conduct of high quality academic and commercial multi centre trials within Ireland so as to ensure that they achieve their agreed national recruitment targets in an efficient and timely fashion, to track the performance of such studies and to intervene as necessary to ensure their successful outcome and thereby maintain and enhance Ireland’s and HRB CRCI’s reputation. Long Term (4 years +)
1. To develop a sustainable model for Ireland’s clinical trials infrastructure that ensures secure uninterrupted funding of essential services.
2. As resources allow to extend the number a university affiliated hospitals sites working with HRB CRCI.
3. Support the development of academic and commercial early phase trial activity.
4. Support the accreditation of Irish CRF/C services to an appropriate international standard. 5. Enhance the integration and support of Patient Focused Research within and by the HSE.
A key feature of Irish Medicine is that a relatively small number of clinicians care for a larger number of patients than is the international norm. HRB CRCI will build on this by supporting the interaction of clinicians with academic and commercial funders. If sufficiently supported and coordinated, a relatively small group can undertake multicentre trials that can substantively address important clinical questions of international relevance. What will be different in Phase II: HRB CRCI will expand for the existing group of partners, with the introduction of the National Children Research Centre in 2017 and the proposed addition of University of Limerick to MMI and HRB CRCI in Phase II. This will result in the network encompassing all of proposed Hospital Group affiliated Universities and provides a framework by which once HRB CRCI is adequately resourced it can provide truly national service throughout the country. HRB CRCI Directors believe that a centrally funded clinical trial infrastructure extending across all of the CRF/Cs will be a critical requirement for long term sustainability of the nascent Irish clinical trial environment. Only 3 of the partner CRF/Cs have a dedicated HRB funded Quality Manager and this is destabilising aspects of the HRB CRCI mission, in particular, the role-out of the National Quality Program and Mutual Recognition Policy. We will seek to partially compensate for this by proposing that HRB CRCI will fund a part-time quality manager in the non HRB funded sites. HRB CRCI will seek to proactively support the early development of multicentre academic trial applications by providing a site feasibility and recruitment potential assessment (analogous to that undertaken with commercial trials) and it will provide advice on the specific structures and services required for multicentre trials, especially if regulated. We will in Phase II modify the work practises of the CILO to achieve a greater integration of supports offered to Medical Device and SME customers with CRF/Cs and enhance interaction with HIHI.
During Phase I HRB CRCI has very successfully increased the visibility of Irish clinical trial infrastructure both nationally and internationally and has rapidly grown the volume of commercial trial feasibility requests. These are currently assessed at an individual investigator level. The resulting volume of potential activity already exceeds the net capacity of the Irish infrastructure to guarantee the delivery of a high quality end-product. Furthermore by working at the individual researcher level and without regard to the experience, skill mix and support requirements of the overall group of potential investigators nationally, results on a national level are likely to be unpredictable and variable. In Phase II we will focus on streamlining this growth by selecting a smaller number of appropriate projects for which there is sufficient volume and expertise of investigators as to optimally deliver high quality efficient trial conduct that meets the agreed country level recruitment targets in a timely fashion, thereby developing Ireland’s reputation as a research destination of choice and laying the foundation for a successful charging strategy to ensure long term sustainability. For Phase II we have modified several of our KPI’s to better reflect the work that HRB CRCI contributes, thus while we previously referred to several trial performance measures as KPIs during Phase I, the responsibility of HRB CRCI is in regard to the tracking and collating of these performance metrics rather than the actual performance itself which is the responsibility of the individual CRF/Cs. The provision of such metrics is critical in allowing for coordinated and controlled growth of multicentre trials in Ireland.