‘Research and innovation’ is a key focus for the Global Action Plan for Dementia (2017-2025), and the imperative for Dementia Trials Ireland (DTI). DTI will be a world-class clinical trials infrastructure to support and grow dementia intervention studies for the >150,000 people with/at risk of dementia in Ireland. Currently, less than 0.5% of people with dementia participate in research in Ireland, despite the need for evidence to address the rapidly increasing impact of dementia on our aging society. By significantly increasing Ireland’s capacity and capability to delivery dementia-related trials, and by increasing the number of people participating in trials, DTI aims to prevent/slow progression to dementia for those at risk, and to improve quality of life for people with dementia.
DTI’s four work packages (WPs) will support portfolio-adopted investigator-led and industry-sponsored studies spanning the life course of dementia, from pre-dementia to advanced stage dementia.
WP1, ‘Trial Readiness’, will prepare our research work force to develop and deliver dementia trials, focusing on training for trial conduct, and education/development of early-career researchers (‘DTI Fellows’). In partnership with HRB’s Trials Methodology Research Network (HRB-TMRN), trial delivery training will include: outcome rater training, Good Clinical Practice (GCP) specific to vulnerable adults, working with participant dyads (including participants’ care partners), and conducting research in complex settings (i.e. private homes and nursing homes). We will increase Principal Investigator capacity for dementia research by supporting early-career clinical researchers through mentorship, observerships and links with HRB-TMRN trial methodology courses. Training of interdisciplinary dementia-related professionals in a global context will be supported by our collaborator, the Global Brain Health Institute, Trinity College Dublin.
WP 2, ‘Trial Development’, will foster new funding proposals, and provide a single point of access for industry sponsors and international collaborators seeking to work with Irish investigators on multi-centre trials. In WP2, DTI’s Dementia Trials Advisory Group (D-TAG) will foster/expand inter-disciplinary collaborations among university- and HSE-based investigators, clinicians, third sector organisations, policy developers, and people living with or at risk of dementia, and their care partners, to develop new trials, supported by the HRB-TMRN. Through D-TAG Task Forces (focusing on special populations or interventions) and Writing Groups, DTI will provide the groundwork for new intervention studies, including evidence syntheses and core outcome set (COS) development.
WP 3, ‘Trial Delivery’, will ensure world-class delivery of dementia trials in Ireland, by embedding DTI within existing HRB research assets (HRB-Clinical Research Coordination Ireland (HRB-CRCI) and the Clinical Research Facilities/Centres (CRF/Cs: Cork, Dublin, Galway)) and Ireland’s Health Service Executive’s (HSE) clinical assets (i.e. hospital partners in Cork, Sligo, Dublin) to support: study hosting, recruitment, personnel/equipment, governance, study start-up and approvals, and trial performance monitoring, with remediation for under-performing trials.
WP 4, ‘Person and Public Involvement’ (PPI) will crosscut the entire programme, ensuring that the perspectives of people with/at risk of dementia are represented in all stages of work, from conception to dissemination. DTI’s PPI program will be linked to existing dementia-related PPI programmes in GBHI, the Alzheimer Society of Ireland and the HRB/IRC-funded national PPI Network.
