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
