Professor Elaine McColl Elaine McColl is the Director of the Newcastle Clinical Trials Unit (NCTU), a fully registered CTU within the UK Clinical Research Network’s (UK CRN) framework. The NCTU forms a programme of research within Newcastle University’s Institute of Health and Society, and is one of the Newcastle Biomedicine Clinical Research Platforms. The remit of the NCTU is the design, conduct and analysis of randomised controlled trials and other high quality studies, of both pharmaceutical and complex interventions. NCTU has a strong track record in HTA-funded trials, often with a qualitative component. Elaine is a social scientist by background, but has worked in applied health services research, in her native Ireland and in north east England, for over 20 years. In addition to the design and conduct of clinical trials, her personal research interests include chronic disease management and the assessment of patient reported outcomes. Her PhD was awarded on the basis of her publications in this latter field. Elaine is one of the co-applicants for funding on the FiCTION trial, bringing expertise in trial design and the importance of pilot studies. The trial management, statistical analysis and economic evaluation elements of the FiCTION study are led from Newcastle, under Elaine’s direction. In particular, she supports the FiCTION trial management team in the day to day running of the study, and makes an intellectual contribution to assessing trial feasibility and to any necessary re-design for the main trial.