B1386
Title: Designing an adaptive platform for an evolving pandemic: The PRINCIPLE trial
Authors: Joe Marion - Berry Consultants (United States) [presenting]
Abstract: The PRINCIPLE trial is a randomized, adaptive, perpetual platform trial enrolling an outpatient population with COVID-19. As one of the UK's national priority trials, the PRINCIPLE trial was established early in the pandemic to assess the effectiveness of repurposed drugs for the treatment of COVID-19. Designing this clinical trial in a rapidly changing environment for a then-unknown disease presented substantial challenges. The aim is to discuss the adaptive and statistical elements of the design that were chosen to facilitate the rapid evaluation of drugs, while also providing the flexibility necessary to accommodate the uncertain and evolving pandemic landscape.
