A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial

In this episode of "In the Interim…", Dr. Scott Berry connects with Dr. Byron Gajewski, professor of biostatistics and data science at the University of Kansas Medical Center (KUMC), for a detailed discussion on the design, simulation, and operational realities of Bayesian adaptive clinical trials in academic environments. Gajewski discusses his academic background, training at Texas A&M, and progressive adoption of Bayesian principles based on direct experiential advantages in complex data settings. The conversation highlights KUMC’s Fixed and Adaptive Clinical Trial Simulator Working Group, which utilizes FACTS for faculty, staff, and student collaboration, enabling practical simulation, trial protocol development, and in-house applied statistical training. The PAIN-CONTRoLS Trial serves as a practical example of multi-arm Bayesian adaptive design, using response-adaptive randomization for comparative effectiveness in neuropathy research. The NIH-funded HOBIT trial is examined in detail: multi-arm structure, adaptive allocation among investigational arms, fixed control randomization, group-sequential interim analyses, and sliding dichotomy methodology for the Glasgow Outcome Scale Extended. The discussion stresses a shift to probabilistic, evidence-driven interpretation and reporting, shaping operational choices and academic culture for both investigators and trainees.

Key Highlights

• Gajewski describes how practical challenges in real-world problems catalyzed his transition to Bayesian modeling.
• KUMC’s working group integrates FACTS software in collaborative simulation and operational trial planning.
• The PAIN-CONTRoLS Trial: multi-arm Bayesian adaptive design, response-adaptive randomization, real-time analysis, and endpoint-driven allocation.
• HOBIT trial: Adaptive allocation, fixed control arm proportion, group-sequential interims, ordinal endpoint modeling.
• Emphasis on probabilistic, quantitative reporting over binary outcomes in trial analysis and interpretation.
• Cultural shift observed among academic collaborators and trainees embracing Bayesian adaptive strategies.