Kert Viele discusses the challenges and probabilities of success in a drug development program, highlighting that a standard approach often leads to a high rate of failure due to poor dose selection in early trials, but suggests that a revised strategy of continuous patient allocation and dose escalation can significantly improve the chances of successfully bringing an effective therapy to market.

Kert Viele discusses the concept of historical borrowing in clinical trials, highlighting its potential benefits and risks, particularly in relation to FDA guidance and the importance of assessing "drift" to determine when it is appropriate to utilize historical control data for improving trial efficiency and accuracy.

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.

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.