Don Berry speaks as part of the press conference for I-SPY 2, an innovative breast cancer clinical trial.

The article emphasizes the importance of optimizing clinical trial designs by investigating multiple therapies simultaneously and utilizing strategies like Bayesian thinking and platform trials to significantly reduce the time and resources needed to identify effective treatments for difficult medical conditions.

Highly powered clinical trials are costly and often yield statistically significant but clinically meaningless results due to large sample sizes designed to mitigate random errors, suggesting the need for alternative approaches like flexible sample sizes and group sequential designs to optimize resource use and improve trial efficiency.

This Podcast series by JAMA provides valuable interviews about the statistical and methodological foundations of clinical research.

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.