Clinical trials, also known as randomised or randomised controlled trials, are studies conducted to evaluate the potential benefits (and risks) of health care interventions such as new medical treatments. These studies provide the best evidence base for informing decisions on the effects of interventions. This means health care users and professionals can make more informed choices about treatment options. These are exciting and challenging times for clinical trials. The number and variety of treatments available is growing, increasing pressure on researchers to determine how these compare to current treatments. However rising costs and regulations can make these trials expensive and complex. Now more than ever, we need high quality research to ensure that the right trials are done, in the right ways and reported fairly and clearly.
The ‘HRB-Trials Methodology Research Network (HRB-TMRN)’ is a new, collaborative initiative between a number of Irish and international higher education institutes and methodology centres. Its mission is to strengthen the methodology and reporting of trials in health and social care on the island of Ireland so that they become more relevant, accessible and influential for patients and other service users, practitioners, policy makers and the public. This will be achieved through a programme of work relating to the methodology of trials and focussed on (i) support (ii) training and education and (iii) research and innovation.
Objectives; (i) Develop clusters of excellence in specific areas of trial methodology research to (a) support forums for the discussion and exchange of ideas on a specified thematic area, issue or problem and (b) 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 trial investigators, research staff and clinical staff involved in the recruitment and follow-up of participants to trials and prioritise collectively their areas of uncertainty to develop a research agenda; (iii) Conduct methodology research to a high international standard in priority areas for the UK and Ireland, including initiatives that (a) support collaboration and enable groups of researchers and other stakeholders to explore ideas together, thereby maximising opportunities for new networks and interactions (b) deliver greater involvement of service users, practitioners, policy makers and the public in trials and (c) embed methodological questions in trials and systematic reviews; (iv) Build capacity and knowledge in trial methodology through training and support with an emphasis on appropriate trial design, and on the impact and opportunities presented by different methods of dissemination of evidence from trials; (v) Improve the reporting and understanding of research through (i) training in issues related to peer – review and (ii) through evaluations of different methods of disseminating research findings to key stakeholder groups. (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) By providing methodological support for trialists. Such support is vital to enhance the quality of trials being undertaken.