The discussion highlights the growing role of real-world evidence in clinical trials, particularly as a potential substitute for control arms, while emphasizing the need to address biases associated with various control methods and advocating for a future dominated by platform trials that balance cost savings with reduced bias risks.

Hierarchical modeling is an advanced statistical approach used in clinical trials to make inferences across multiple patient groups, enhancing power and reducing sample sizes while requiring careful implementation to account for variability and potential biases in observed data.

This week, we published an article in JAMA titled “Bayesian Analysis: Use of Prior Information in Clinical Trials,” which explores the nuances of Bayesian analysis in clinical trials, emphasizing the importance of transparency and community consensus when using informative priors to avoid bias and enhance trial efficiency.

This is a plan for a Phase Ill trial to explore the efficacy of Argatroban and Eptifibatide in combination with rt-PA in treating stroke patients. Two doses of each combination will be compared to a control (rt-PA only) arm with respect to their ability to improve subjects' 90 day scores on the modified Rankin scale (mRS).

Todd Graves, who joined Berry Consultants in January 2012, plans to regularly blog about innovative clinical trial designs and his statistical modeling for college football team ratings, sharing insights and updates on both topics.

Jason Connor will be participating in several upcoming events, including presentations on Bayesian adaptive trials and findings at various conferences and teaching a class at Johns Hopkins School of Public Health from May 31 to June 28.