These are exciting and challenging times for clinical trials. The number and variety of treatments continues to grow, increasing pressures on researchers to determine how these compare to current treatments, while rising costs and regulation can make trials expensive and complex. However, as pressure on resources grows, there is more demand for reliable and robust evidence on the benefits, harms and costs of health care, so that people can make informed choices. This backdrop means that we need high quality research to ensure that the right trials are done, in the right ways and reported fairly and clearly. We propose the development of a HRB Trial Methodology Research Network (HRB-TMRN), which will be underpinned by the vision of a community of experienced trialists and methodologists working together so that trials in health and social care become more relevant, accessible and influential for patients and other healthcare users, practitioners, policy makers and the public. This proposal sets out the themes, and necessary objectives, which would form a core for the work of the Network until the latter part of 2017. In summary, our objectives are to: (i) Develop clusters of excellence in specific areas of trial methodology research to support and influence the quality, relevance and impact of trials on the island of Ireland, in the UK more widely and internationally. (ii) Identify the unanswered questions about trial methodology from the perspective of different key stakeholders; (iii) Conduct and disseminate methodology research to a high international standard in priority areas; (iv) Build capacity and knowledge in trial methodology through training and support to improve practice and patient outcomes; (v) Improve the reporting and understanding of research through training and evaluations of different methods of disseminating research findings; (vi) Establish strong collaborative networks with the individual Irish University based Clinical Research Facilities/Centres, the proposed HRB National Clinical Research Framework (‘Clinical Trials, Ireland’), the MRC All Ireland Hub for Trials Methodology Research (Belfast), other MRC Hubs for Trials Methodology Research, and other centres with relevant expertise in the UK and Ireland, and internationally; (vii) Provide methodological support for trialists. Our overarching mission is to strengthen trial methodology and reporting on the island of Ireland, through a programme of work, which will also impact elsewhere in the UK and internationally. We will achieve this through a focus on three high-level activities relating to the methodology of trials (i) support (ii) training and education and (iii) research and innovation. Our portfolio of activities will have a particular, but not exclusive, focus on 3 core themes :(i) To increase the involvement of healthcare users, practitioners, policy makers and the public in trials; (ii) To raise awareness of Global health, and promote and support trials in resource-poor settings and disaster medicine; (iii) To improve the impact of trial evidence on practice through dissemination of evidence from trials (including via systematic reviews). The focus on these 3 themes provides particular vectors through which the Network will apply its three functional activities of (i) methodology support (ii) methodology training and education and (iii) methodology research and innovation. Further, a wider range of research, training and support and research dissemination activities are likely to emerge and evolve from the strategic planning process that will be part of the ongoing work of the Network. We will implement 3 broad Activities (effector functions), namely: Support: We will support the clinical trial community in Ireland through the development of a network of expertise that supports rigorous application of established and appropriate trial design principles, methodologies and reporting. The support will help trialists to prepare methodologically sound grant applications, and to develop rigorous protocols, and to conduct and disseminate reliable and robust trials that will influence decision making in health and social care. This support programme will also provide opportunities for trialists to engage with and develop research within research (see Study Within a Trial (SWAT) innovation below), embedding methodology research within the health and social care trials. The support structure will be diffuse in that individual researchers will be encouraged to make first contact with a local member of the Network (which is most likely to be the CRF/Cs and CSTAR). If the local contact is unable to provide the necessary guidance, the query will be shared across the Network in order to identify the necessary advice and, if that is still not forthcoming, the Network will explore the opportunity to make use of the MAST service offered by the MRC Network of Hubs either directly or via the MRC Hub in Northern Ireland. This Activity will be supported in part by development grants (e.g. EI support for H2020 applications) and by a fee applied to successful grants for protocol development. Over time, it is expected that much of the routine methodological support of Trial applications will be provided directly by CRF/C as their capacities and expertise grow, moving some of this activity from the Network, allowing it to focus on the particularly complex support needs or areas in which there is considerable uncertainty and a need for methodology research. In dealing with queries from trialists that cannot be solved locally, we will develop a “buddying” system in which both the trialist and a relevant person from their local Network contact point receive advice from elsewhere in the Network or outside, in order to increase the knowledge of both the trialist and the Network. This aspect of the Network’s programme will also see the development of a database of trial methodology expertise in Ireland, providing a national map of appropriate human resources. Training and education: The Network’s programme of training and education will seek to improve capacity in Ireland for the conduct, reporting and use of high quality trials in health and social care. It will focus initially on the three defined themes and their application to specific topic areas. The programme will be delivered by a variety of means including seminars, short courses, summer schools, and internet resources. At the individual level, it will include mentoring and placement of PhD candidates working on trial methodology projects. These activities will be supported by the core grant and are an important means of establishing links with international centres of excellence and enhancing the visibility, work and reputation of the Network. Assistance with cross-institutional supervision and placements for PhD candidates in international centres of excellence will be available to any interested candidate who has secured funding. Collaborators have already expressed a willingness to support this activity. Research & Innovation: The Network will facilitate novel research into issues of the design, conduct, analysis and dissemination of trials. Initially, the 3 PhD candidates and their supervisors, whose support has already been pledged by 3 of the co-applicant universities in Ireland, will conduct this. It will also draw upon the PhD programme being developed at the Northern Ireland Hub. This initial research programme will be augmented over time by project-specific research grants that directly support the research. Furthermore, opportunities to avail of existing trial infrastructure to conduct a piece of methodology research within a trial at low cost will be exploited. This will include participation in the SWAT (Study Within A Trial) initiative being developed by the Northern Ireland Hub with Prof. Devane (Smith 2013), in association with the MRC Network of Hubs and the MRC START programme, and the Network’s core grant, which will support two SWAT awards per year. This may be sufficient for the self-contained conduct of a research study or might be the seed money needed to develop a more substantial funding proposal. These collaborations are critical to the success of the Network and by encouraging the conduct of SWATs and other similar projects they are can be done quickly and efficiently.At the end of the funding period, the trials that the Network is involved with will be more usable in every sense of the word – better designed, conducted and reported, more useable for decision makers and more usable within systematic reviews.
