Antiviral Treatments for Pandemic Influenza: A Bayesian Adaptive and Open Platform Randomized Trial

• Activity Number: 479
• Type: Topic Contributed
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Benjamin Saville*
• Companies: Berry Consultants
• Keywords: Bayesian ; adaptive ; platform

Abstract

PREPARE is a European Commission funded network for the rapid and efficient delivery of large-scale clinical research studies on infectious disease. PREPARE aims to develop the capability to rapidly implement prospective clinical research during pandemics. To facilitate this aim, a large prospective randomized trial is planned in Europe to evaluate antiviral treatments for pandemic influenza. This platform trial has a master protocol that allows antiviral treatments to be dropped and replaced by other experimental treatments. The primary outcome is time to return to usual activities without symptoms of influenza. Bayesian response adaptive randomization is used to allocate more patients to effective therapies depending on a patient's demographic and clinical subgroup. Extensive simulations are used in the planning stages to explore operating characteristics.