Kaspar Rufibach

In this discussion, Kaspar Rufibach, an experienced biostatistician and adaptive clinical trial expert, delves into the practicalities of adaptive designs and the ICH E20 guideline. He explains why these designs save time and the types of meaningful adaptations available for drug development. Kaspar also addresses the operational barriers preventing wider use of adaptive trials and emphasizes the importance of understanding their implications on endpoints and inference. Lastly, he outlines the key points of the new ICH E20 guideline that statisticians should note.

In this engaging discussion, Kaspar Rufibach, an experienced biostatistician and authority on adaptive clinical trials, shares his insights. He explains the challenges of communicating results from adaptive studies and emphasizes the importance of using clear, defensible language. Listeners learn about the difference between conditional and unconditional bias, the implications for point estimates, and the significance of median-unbiased estimation. Kaspar also addresses the complexities surrounding secondary endpoints and the necessity of pre-specifying adjustments to ensure trust and reproducibility.

Kaspar Rufibach, an expert in survival analysis and member of the SAVVY collaboration, and Jan Beyersmann, a professor of biostatistics at Ulm University, discuss the complexities of analyzing adverse events in clinical trials. They highlight how varying follow-up times can bias results and advocate for using the Aalen–Johansen estimator as a standard practice. The conversation emphasizes the successful collaboration between pharma and academia, revealing how real-world data can change the perception of treatment risks and enhance benefit-risk evaluations.

In this insightful discussion, Kaspar Rufibach, an expert in statistical hypothesis testing, dives into the often-misunderstood world of p-values and confidence intervals. He explores the historical debates between Fisher’s and Neyman-Pearson’s approaches, shedding light on their practical implications. Kaspar shares real-world examples from clinical trials, emphasizing the risks of misinterpretation and the importance of clear communication. His tips for applying statistical concepts effectively can enhance collaboration with clinicians and strengthen the integrity of research.

Kaspar Rufibach, an influential statistician specializing in survival analysis, dives into the complexities of non-proportional hazards. He discusses the vital differences between hazard functions and survival functions while emphasizing their clinical relevance. The conversation highlights effective communication strategies for non-statisticians and the importance of innovative data visualization. Kaspar also explores challenges in trial design and suggests alternatives to traditional effect quantification methods, all aimed at enhancing the understanding of treatment dynamics in clinical settings.