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.

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.

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.

Since March 2020, Berry Consultants LLC has been collaborating with the Los Angeles County Department of Health Services to develop COVID-19 hospital demand modeling projections, utilizing an SEIR epidemiologic model to predict hospital needs and assess the impact of physical distancing measures, with their findings prominently featured in various media outlets.

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.