{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"In the Interim...","title":"Revisiting Seamless 2/3 Trial for GLP-1 Agonist","html":"<iframe width=\"100%\" height=\"180\" frameborder=\"no\" scrolling=\"no\" seamless src=\"https://share.transistor.fm/e/0ef0f6e6\"></iframe>","width":"100%","height":180,"duration":2557,"description":"In this episode of \"In the Interim...\" we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity. We discuss the intricacies of the adaptive trial design, and the unique features that helped expedite development by 12-18 months. Listeners will gain insight into how Bayesian algorithms and innovative statistical methods were pivotal in navigating a complex trial design, benefiting Eli Lilly's pipeline and changing the landscape of diabetes treatment.Key Highlights:Outline of the trial design and the barriers faced during its inception in 2007-2008.Explanation of the Clinical Utility Index and its role in adaptive randomization.The DSMB's role and interaction with Bayesian decision-making models.Simulation-based design to optimize development efficiencies.Insights into the predictive power of the trial on weight loss outcomes in subsequent trials.Quotes:\"The trial was run entirely by Bayesian algorithms.\" – Scott Berry\"They believed this utility function was absolutely the right way to go forward.\" – Scott Berry","thumbnail_url":"https://img.transistorcdn.com/toFATB0JXvqQXRqzUqrK1EWCJCLOA_Qvjkb5ml3q-s8/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS9jM2M0/ZDE2YzA1N2FhNjkx/NDk1NDczNjYzM2E5/NjlmYS5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}