{"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":77,"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":"2026-09-08T00:17:11.625653+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889"},"episode":{"title":"A Statistician Reads JAMA: A Futile Issue","slug":"a-statistician-reads-jama-a-futile-issue","published_at":"2026-06-22T11:00:00+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889/a-statistician-reads-jama-a-futile-issue","show_page_url":"https://stenobird.com/podcast/in-the-interim-7211889","url":"https://share.transistor.fm/s/387e2f75","audio_url":"https://media.transistor.fm/387e2f75/2fb46a23.mp3","summary":"On the latest episode of \"In the Interim…\", Dr. Scott Berry provides an empirical examination of two recent JAMA trials: TRACK (low-dose rivaroxaban in advanced kidney disease) and VICTORY (IV vitamin C in severe burn injury). The TRACK trial lacked any pre-specified futility criteria, with a DSMB-initiated stop based on conditional power calculations. Scott argues that conditional power, especially in this interim context, is a poor, misleading tool—contrasting it against a Bayesian predictive probability calculation that produced a much lower and more realistic estimate of success. In VICTORY, a pre-specified risk ratio threshold for futility was incorporated, with simulation confirming minimal effect on bias and statistical power. Scott underscores the practical and ethical importance of rigorously pre-specified, simulation-based futility rules and operationalizes the case for Bayesian predictive probability as a decision metric in interim monitoring. He reiterates that responsibility for defining futility belongs to trial designers, not left to ad hoc DSMB judgment, and calls for precise statistical planning in adaptive trial protocols. Key Highlights TRACK: No pre-specified futility rule; DSMB stopped for futility using conditional power post hoc. Technical critique of conditional power as misguided at interim, supporting Bayesian predictive probability instead. VICTORY: Pre-specified futility threshold, with simulation confirming minimal operational bias and power reduction. Emphasizes pre-specified, simulation-based futility planning and predictive probability monitoring as standards for all trials. For more, visit us at https://www.berryconsultants.com/","meta_description":"On the latest episode of \"In the Interim…\", Dr. Scott Berry provides an empirical examination of two recent JAMA trials: TRACK (low-dose rivaroxaban in ad…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2773,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/in-the-interim-7211889/episodes/a-statistician-reads-jama-a-futile-issue/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-statistician-reads-jama-a-futile-issue.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}