Author: Professor Deborah Ashby Interim Dean of the Faculty of Medicine, Imperial College London
About the lecture
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 where they rapidly informed clinical 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.
