About the talk

During a clinical trial, accruing data is often seen in confidence by a data monitoring committee to evaluate whether early termination of the study or other modifications are needed in the light of emerging results. For a classical two-group trial with a single primary endpoint there are well-established statistical approaches. However, more complex trials, such as platform trials or trials with multiple endpoints, present different challenges. Such designs are now being used more regularly, including during the recent COVID-19 pandemic wher they rapidly informed clincal practice. We review these designs and current approaches to data-monitoring, as well as challenges that are emerging, and outline where further developments are needed.

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About Deborah

Professor Deborah Ashby is Interim Dean of the Faculty of Medicine at Imperial College London where she holds the Chair in Medical Statistics and Clinical Trials. She was previously Director of the School of Public Health and was Founding Co-Director of Imperial Clinical Trials Unit. Her research interests are in clinical trials, risk-benefit decision making for medicines, and the utility of Bayesian approaches in these areas. She is a Chartered Statistician and Honorary Member of both the Royal College of Radiologists and the Faculty of Public Health Medicine. She was awarded the OBE for services to medicine in 2009, appointed an NIHR Senior Investigator in 2010, elected to the Academy of Medical Sciences in 2012 and was President of the Royal Statistical Society for 2019 and 2020.