November 02, 2023 Webinar
Innovative Design and Analysis Approaches for Master Protocols
James Wason, PhD
Abstract
New statistical methods and trial designs have a big role to play in improving clinical trials. They can lead to more efficiency, better evidence and better outcomes of patients enrolled on the trial. In this talk, I will discuss several areas of research about using an innovative class of trial design called master protocols. Master protocols allows combining several separate but related clinical trials together. This provides substantial operational and statistical advantages. However, it also introduces several statistical issues that new methods are required for addressing. My talk will concentrate on how master protocol approaches pioneered in oncology, such as basket and umbrella trials, may be made useful in other areas, especially chronic inflammatory diseases. I will finish by considering other areas of methodology research that are required to enable maximum utility of the master protocol approach.
Short Bio
James Wason, PhD has been a Professor of Biostatistics at Newcastle University since 2017. He leads a research group that develops and applies innovative statistical methodology for improving the design and analysis of clinical trials. His interests include adaptive clinical trial design, clinical trials in the era of precision medicine, and improving the analysis of composite outcomes. He has authored over 100 publications in a range of statistical and clinical journals.