Platform trials are a new type of clinical trials where multiple interventions can be evaluated simultaneously against a common control group within a single master protocol. Platform trial designs are an extension of adaptive trial designs that are sometimes referred to as a multi-arm, multi-stage (MAMS) design, as multiple interventions (‘‘multi-arm’’) undergoing multiple interim evaluations (‘‘multi-stage’’) are part of the design features. They have the additional flexibilities of allowing new experimental arms to be added and the control arm to be updated during the trial. For platform trials, it is important to consider how interventions are compared and evaluated throughout and how new interventions are introduced. For intervention comparisons, it is important to consider what the primary analysis is, what and how many interventions are active simultaneously, and allocation between different arms. Interim evaluation considerations should include the number and timing of interim evaluations and outcomes and statistical rules used to drop interventions. New interventions are usually introduced based on scientific merits, so consideration of these merits is important, together with the timing and mechanisms in which new interventions are added. The objectives of this webinar are to review the concept of platform trials and discuss important design considerations for platform trials.
About the Speaker
Jay is a Director of Trials Research for Cytel Canada Health. Inc based in Vancouver, BC. He recently joined the company in December 2019 when MTEK Sciences was acquired by Cytel. His research interests include application of master protocols, adaptive trial designs, and real-world analytics to global health. He currently teaches a course on adaptive trial designs and master protocols at McMaster University and is working on a book, “Introduction to Adaptive Trial Designs and Master Protocols” that will be published by Cambridge University Press in 2021.