Clinical Data Management and Statistical Rigour in Academic-Led Clinical Trials

Barriers and facilitators to statistical rigour in academic-led clinical trial design, conduct, monitoring, analysis, reporting and dissemination of findings.

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Marina-ZakiMarina is a PhD student in the School of Nursing, Midwifery and Health Systems in University College Dublin and the HRB-TMRN. Marina has an MSc. Translational Medicine (2015) and BSc. Pharmacology (2013). The focus of her PhD research is on understanding statistical rigour in clinical trials, specifically: academic-led and publicly-funded trials in Ireland. The barriers and facilitators to conducting efficient trial design, conduct, statistical and data monitoring and analysis, decision making, reporting and making statistical and clinical inferences from trial results, from the perceptions of statisticians, healthcare professionals and clinical data management teams, will be looked at. Understanding statistical components that influence and strengthen trial methodology, through an inter-disciplinary approach, is key to Marina’s project. Marina is studying under the supervision of Professor Eilish McAuliffe (Professor of Health Systems, UCD) with co-supervisors Dr. Marie Galligan (Biostatistician and Clinical Research Tutor, School of Medicine, UCD) and Professor Declan Devane (Director of the HRB-TMRN and Professor of Midwifery, NUI Galway). Contact Marina: marina.zaki@ucdconnect.ie

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