Design & Analytic Considerations for Time to Event Outcomes in Randomized Clinical Trials (MtG)

Design & Analytic Considerations for Time to Event Outcomes in Cluster Randomized Clinical Trials How to handle censoring and the need to consider competing/semi-competing risks already increases the complexity of designing clinical trials with time-to-event outcomes. Additional complexity is added when using a time-to-event outcome in a cluster randomized trial because the correlation between individuals within a cluster also needs to be considered. Using the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial, a cluster randomized trial with the primary outcome of time to first serious fall injury, as a motivating example, this talk will discuss considerations in the design and analysis of cluster randomized trials with time-to-event outcomes in the presence of censoring and competing/semi-competing risks. It will also discuss the methods available for clustered time-to-event data and weigh the pros and cons of those methods under varying design considerations. This talk will conclude by outlining the gaps in knowledge that still exist.