{"podcast":{"title":"In the Interim...","slug":"in-the-interim-7211889","podcast_index_feed_id":7211889,"rss_url":"https://feeds.transistor.fm/in-the-interim","website_url":"https://berryconsultants.com","image_url":"https://img.transistorcdn.com/4kEBoJ9pC_kLNSr6AX2uD_qdxx8BJ7dMddtvubROpQ0/rs:fill:0:0:1/w:1400/h:1400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS9jM2M0/ZDE2YzA1N2FhNjkx/NDk1NDczNjYzM2E5/NjlmYS5wbmc.jpg","author":"Berry","episode_count":66,"summary":"A podcast on statistical science and clinical trials. Explore the intricacies of Bayesian statistics and adaptive clinical trials. Uncover methods that push beyond conventional paradigms, ushering in data-driven insights that enhance trial outcomes while ensuring safety and efficacy. Join us as we dive into complex medical challenges and regulatory landscapes, offering innovative solutions tailored for pharma pioneers. Featuring expertise from industry leaders, each episode is crafted to provide clarity, foster debate, and challenge mainstream perspectives, ensuring you remain at the forefront of clinical trial excellence.","last_synced_at":"2026-06-16T00:19:29.083980+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889"},"episode":{"title":"A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial","slug":"a-visit-with-byron-gajewski-kumc-innovative-trial-designs-the-hobit-trial","published_at":"2026-04-06T11:24:37+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889/a-visit-with-byron-gajewski-kumc-innovative-trial-designs-the-hobit-trial","show_page_url":"https://stenobird.com/podcast/in-the-interim-7211889","url":"https://share.transistor.fm/s/e0d93ef4","audio_url":"https://media.transistor.fm/e0d93ef4/98ef7075.mp3","summary":"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: Adapti…","meta_description":"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 K…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2423,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/in-the-interim-7211889/episodes/a-visit-with-byron-gajewski-kumc-innovative-trial-designs-the-hobit-trial/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/in-the-interim-7211889/a-visit-with-byron-gajewski-kumc-innovative-trial-designs-the-hobit-trial.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}