{"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 Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance","slug":"a-visit-with-stephen-senn-time-concurrent-controls-and-the-bayesian-guidance","published_at":"2026-03-30T11:00:00+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889/a-visit-with-stephen-senn-time-concurrent-controls-and-the-bayesian-guidance","show_page_url":"https://stenobird.com/podcast/in-the-interim-7211889","url":"https://share.transistor.fm/s/99fe3d92","audio_url":"https://media.transistor.fm/99fe3d92/fd82a5ca.mp3","summary":"In this episode of \"In the Interim...\", Dr. Scott Berry hosts Dr. Stephen Senn, award-winning statistician and author, for a discussion on advanced challenges in adaptive and platform trial methodology. Senn draws on experience in academic, pharmaceutical, and regulatory settings to address the recent draft guidance on Bayesian statistics from the FDA and multiple controversies in clinical trial design. Key Highlights Emphasizes understanding data origin and regression to the mean as essential for trial interpretation, above adherence to Bayesian or frequentist frameworks. Details methodological considerations for time adjustments and model complexity, highlighting that model specification and parameter handling are critical regardless of statistical school. Identifies the limitations of non-concurrent controls in platform trials, focusing on evolving background therapy, site participation, and protocol changes that reduce validity of historical or pooled control data. Analyzes blinding difficulties in trials with multiple treatments and administration modes, using “veiled” blinding as a case and noting the implications for placebo response comparability. Clarifies that operational efficiencies are the principal advantage of adaptive and platform trials, while purported statistical efficiencies can be exaggerated. Stresses the importance of presenting interim analyses transparently to DSMBs when using complex models for time or covariate adjustment, to ensure oversight and interpretation remain rigorous. For more, visit us at https://www.berryconsultants.com/","meta_description":"In this episode of \"In the Interim...\", Dr. Scott Berry hosts Dr. Stephen Senn, award-winning statistician and author, for a discussion on advanced challe…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2844,"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-stephen-senn-time-concurrent-controls-and-the-bayesian-guidance/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-stephen-senn-time-concurrent-controls-and-the-bayesian-guidance.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}