The MRC ConDuCT-II Hub. COllaboration and iNnovation in DiffiUlt and Complex randomised controlled Trials In Invasive procedures

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The ConDuCT-II Hub is based within the School of Social and Community Medicine, at the University of Bristol and is led by Professor Blazeby, Professor of Surgery. It will include a multi-disciplinary group of academics with established track records in the development of better ways for designing and conducting research to evaluate healthcare interventions. The work will focus on creating new methods and improving existing methods to undertake randomised controlled trials. Randomised controlled trials usually compare two new or standard treatments. The importance of a randomised controlled trial is that patients participating in them could be allocated to either of the procedures under evaluation by a process of randomisation. This means that the patients have an equal chance of having either procedure and so a fair comparison of the outcomes of each of them can be made. These types of studies are the most valid and reliable means of evaluating healthcare interventions, and there is a need for better ways of conducting the trials to inform health policy and practice. There is a particular lack of well designed and conducted randomised controlled trials in surgery and invasive healthcare procedures which means that practice is not based on evidence and standards of surgery and similar invasive procedures vary across the country and within the NHS.The research will be undertaken by four interlinked themes. The themes include: (1) trial prioritisation and design, (2) trial recruitment, (3) feasibility study design and trial conduct, and, (4) outcome assessment, reporting and integration into decision-making. Each theme is underpinned by expertise in statistics and qualitative methods and there are close links to practising clinicians and the two clinical trials units in Bristol, the Bristol Randomised Trials Collaboration and the Clinical Trials and Evaluation Unit. The Hub has additional collaborations with the regional and national registered clinical trials units and other MRC Hubs. The ConDuCT-II Hub will build on these relationships and with new relationships with the Royal College of Surgeons of England Surgical Trials Centres (in Bristol, Oxford, Birmingham and Manchester/Liverpool). The ConDuCT-II Hub will also develop international links to surgeons and methodologists worldwide by providing innovative methods to optimise the conduct of trials in surgery and by provision of specialist training. The ConDuCT-II Hub will undertake methodological research and it will integrate innovative methods into new feasibility studies and full trials in surgery and invasive procedures. The ConDuCT-II Hub will also deliver a training programme for clinicians and other scientists in study design and methods to optimise the design and delivery of complex healthcare interventions and trials in surgery. These courses will also be relevant to trials of public healthcare and primary care interventions. These are similar to surgical interventions because they include multiple components within each intervention, that influence outcomes by acting both together and separately. The training programme will provide an apprenticeship to create a new generation of clinicians who understand and practice evidence based medicine. The new methods will be implemented in new trials and this will lead to evidence to inform healthcare decision-making at policy and practice level. It is anticipated that the ConDuCT-II Hub will ultimately lead to a sustainable change in research culture and it will allow more and even better trials to be developed to answer critical questions of relevance to patients and the NHS.