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.

Berry Consultants will sponsor and host an exhibit booth at the American Statistical Association's Joint Statistical Meetings in Denver from July 27 to August 1, 2019, where they will also present in various sessions.

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.

Berry Consultants has launched a series of informative videos and webinars on clinical trial topics, including disease progression modeling and innovative designs, available on the ICTR website, and invites readers to register for updates and share feedback.