On September 28, 2023, Kert Viele will moderate a panel at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, discussing time trends in ongoing platform trials using real interim analyses from the PRINCIPLE and REMAP-CAP trials, focusing on their impact on clinical trial analyses, modeling adjustments, and the complexities of additive versus interactive time trends.

Berry Consultants is sponsoring the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop from September 27-29 in Rockville, MD, where several team members will be presenting, and attendees can find more information and register on the ASA Workshop Website.

In his blog, Kert Viele discusses the importance of trial design in Bayesian analysis, emphasizing that while conclusions drawn from completed experiments remain consistent regardless of interim analyses, the design of the trial significantly impacts expected utilities, and optimal designs can enhance trial performance.

Public live Zoom webinars on "Introduction to Adaptive Trial Designs using FACTS" are scheduled for October and November.

The blog by Kert Viele discusses the tradeoffs of using external or synthetic data in clinical trials, highlighting how aggressive use can save patient resources but risks scientific robustness, and emphasizes the importance of understanding the agreement between synthetic and actual trial data to optimize inferential performance while minimizing patient enrollment.

The new JAMA Guide to Statistics and Methods by Dr. Barbara Wendelberger and Dr. Roger Lewis examines the concept of futility in clinical trials.