Speaking recently at the launch of the Clinical Research Roadmap, Dr Damian O' Connell, Chair of Molecular Medicine Ireland announced that the MMI partners would work together to increase the number multi-centre clinical studies in Ireland and in particular, to improve the experience of industry in conducting clinical trials in Ireland. He said that MMI was taking this initiative in the context of the Renewed Programme for  Government which commits the government parties to making Ireland ‘a leading country for the timing, access and relevance of clinical trials'.

  

 Dr Damian O’ Connell (Chair, MMI) with Dr Ruth Barrington (CEO, MMI) and Mary Harney TD, Minister for Health and Children

The recently published Report of the Innovation Task Force endorses the need for strong alliances between third level institutions that focus on innovation. It highlights the opportunities for this country to capture innovation from convergent technologies in the pharmaceutical and biotech sectors and from our strengths in research on food and health, and expertise in medical device technologies. It also points out that ‘the development of a clinical trials research system is critical for the future growth and development of this sector in Ireland (both indigenous and MNCs) and to ensure that we leverage investments in research and development - translating from bench to bedside.’

Dr O’Connell, who is also Vice President for Research and Development with Pfizer, referred to an address he had made at the IPPOSI Strategic Forum on Clinical Research in November 2009. ‘I spoke about the changes in the way the pharmaceutical industry funds clinical research and what Ireland has to do to become a core site again for clinical trials.’ A combination of logistical problems and financial pressures has led companies to reduce the number of countries in which they conduct clinical trials as a strategy to increase the speed of study execution and reduce costs while maintaining quality. ‘At an operational level, industry – both global and indigenous - wants a rapid assessment of the feasibility of a study, no undue delays between the decision to conduct the study and the recruitment of the first patients and the target patient population recruited within the agreed timescale’, he commented. Industry wants predictable costs and a high level of regulatory compliance and it wants to be able to navigate the system of clinical research easily.

‘At a strategic level, we need to be able to tell industry what we are good at researching in this country and what matters to us in terms of improving the health of the population’, Dr O’Connell continued. ‘As a small country, we cannot be good at everything so we must prioritise and map our clinical research strengths and our health needs. Building the patient registries and bio collections linked to those priorities, coupled with a much improved capacity to undertake clinical trials, will be of interest to industry and will generate more clinical research and more jobs in Ireland.’

Dr O’Connell asked the question ‘what can MMI and its partners offer industry?' The answer is that MMI can offer the support of the network of clinical research centres that are in place or planned across the country for which the MMI partners are responsible. The CRCs established by RCSI (Beaumont Hospital), UCD (Mater and St Vincent’s), NUI Galway (University College Hospital) and the emerging CRCs TCD (St James’s Hospital) and UCC (Mercy University Hospital) have extensive experience of conducting clinical research, including clinical trials, to a high standard. Each CRC can support academic and industry sponsored studies to standards and timelines that PIs operating independently can find difficult to meet. As a network of CRCs, they can offer support for studies of a scale or of a complexity that have been difficult to undertake in Ireland before now.

Dr O’Connell said that as Chairman of MMI he was pleased to announce that the MMI Board has endorsed the creation of an ICRIN Working Group that, before the end of 2010, will address the following issues:

• Enable a rapid assessment of the feasibility of undertaking studies across the network
• Oversee the adoption of the research readiness programme in participating CRCs and research groups
• Agree and adopt a schedule of research services and predictable charges to industry for the standard research procedures to be carried out in multi-site studies in the network
• Will negotiate with the MMI partners and those associated hospitals that are responsible for Recognised Ethics Committees (RECs), a memorandum of agreement around agreed timelines for the ethical review of industry-sponsored, multi-centre clinical trials to be carried out by the network, for electronic submission of applications to the RECs and for parallel site specific assessment for hospital participation in such studies. The performance of the partners against agreed metrics of performance to be audited by an independent third party and published annually
• Following a trial period of a clinical informatics system in the Dublin Centre for Clinical Research later this year, the ICRIN Network Committee will commit to adopting a common clinical informatics platform across the network
• The ICRIN Working Group will seek resources to develop a web portal with a strong industry facing dimension to promote the research ready network, assist industry navigate the resources available to support their clinical trials and highlight the benefits to industry of undertaking clinical trials through the network in Ireland
• Will address such other issues that arise in consultation with industry to make Ireland a more attractive location for industry sponsored clinical trials.

   

The ICRIN Working Group is chaired by Professor Larry Egan, Acting Clinical Director of the NUI Galway CRC at University College Hospital Galway. Its members include leading clinical researchers responsible for the CRCs in place or planned in Dublin, Cork and Galway. Dr O’Connell said that the Group would work closely with all stakeholders to facilitate multi-centre studies. ‘This initiative demonstrates the MMI partners’ commitment to implementing key recommendations of the Clinical Research Roadmap and to making Ireland a leading country for the conduct of clinical trials’, Dr O’Connell said.

For further information please contact Marie Mellody, ICRIN Coordinator, marie.mellody@molecularmedicineireland.ie