All Times EDT
Keywords: Master Protocols, Effective Communication, Treatment Adaptations, IRT, Randomization, Flexible Randomization, Statistical Leadership, Team Collaboration
Master Protocols facilitate innovation with their ability to seamlessly integrate new treatment additions during an active clinical trial. Often the statistical team will design a flexible randomization scheme within the Interactive Response Technology (IRT) software to allow treatments adaptations to occur in real-time without having to create a new randomization list for each adaptation. However, the challenge lies within the execution of that vision in accounting for outside operational factors (e.g., clinical supplies requirements, dispensation/dosing, entering the adaptations within the IRT, etc.). To efficiently and effectively onboard new treatments, statistical leadership and collaboration with the Operational team is required. The speed of treatment adaptations is likely predicted by the level at which the Statistical and Operational teams can learn to speak each other’s language. This is essential to engaging in meaningful dialogue about the impact of the operational factors on the randomization. The Operational team needs to gain an understanding of how these factors can impact randomization. When the IRT includes flexible configurations (e.g., ability to open/close treatments, ratio adjustments, etc.) that can directly impact randomization, statisticians will be called upon for training and consultation on administering the adaptations within the IRT throughout the trial. Additionally, statisticians should develop an awareness of those factors which fall outside of a typical statistician role. Through examples, checklists and illustrations this poster will arm the statistician with tools to engage the operational team to ensure the vision of seamlessly adding a new treatment becomes reality. Topics include training for administering IRT randomization configurations, potential impact of site readiness (or lack thereof) for new treatments on randomization and building effective communication across stakeholder groups when onboarding new treatments.