{"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":"Talkin' 'bout Sweet Time","slug":"talkin-bout-sweet-time","published_at":"2026-08-31T11:00:00+00:00","page_url":"https://stenobird.com/podcast/in-the-interim-7211889/talkin-bout-sweet-time","show_page_url":"https://stenobird.com/podcast/in-the-interim-7211889","url":"https://share.transistor.fm/s/185d84b5","audio_url":"https://media.transistor.fm/185d84b5/4209e6da.mp3","summary":"In this episode of \"In the Interim...\", Dr. Scott Berry dissects prevailing concepts of “clinically meaningful difference” in clinical trials focusing on progressive diseases. Through detailed examples from pancreatic cancer (Ben Sasse, Revolution Medicines), emphysema (Elevair), Alzheimer’s disease (lecanemab), and IVF, Scott challenges the adequacy of the population-mean of a continuous outcome in reflecting true patient benefit. The episode discusses inconsistent usage and interpretation of acronyms such as MCID, CSD, and Target Product Profile (TPP). Dr. Berry advises trialists to resist interpreting the mean difference using patient-level minimal effects, and adopt responder analyses and cumulative probability approaches to enhance patient-level relevance. Guidance is offered for analyzing the effect of time-saved instead of a mean differences in a clinical endpoint at a single time for progressive diseases – measuring “sweet time.” Key Highlights Focus on added time not the change from baseline as the most meaningful outcome for a progressive disease. In-depth evaluation of MCID, CSD, TPP, and risk of misinterpretation. Critique of trying to interpret mean-based endpoints for clinical meaningfulness such as six-minute walk distance and CDR sum of boxes. FDA advisory panel guidance on MCID for IVF live birth endpoints and dichotomous versus continuous endpoints. Advocacy for responder analyses and cumulative probability of achieving thresholds in reporting the clinical effect of a treatment. For more, visit us at https://www.berryconsultants.com/","meta_description":"In this episode of \"In the Interim...\", Dr. Scott Berry dissects prevailing concepts of “clinically meaningful difference” in clinical trials focusing on…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2823,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/in-the-interim-7211889/episodes/talkin-bout-sweet-time/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/talkin-bout-sweet-time.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}