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In the Interim...
Berry
25 episodes
5 days ago
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.
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Mathematics
Health & Fitness,
Medicine,
Science
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All content for In the Interim... is the property of Berry and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Mathematics
Health & Fitness,
Medicine,
Science
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Bayesian Approach in Clinical Trials
In the Interim...
43 minutes
2 weeks ago
Bayesian Approach in Clinical Trials

This episode of "In the Interim…" features Dr. Scott Berry, Dr. Kert Viele, and Dr. Melanie Quintana of Berry Consultants dissecting the technical and operational landscape of Bayesian statistics in clinical trial design. The episode discussed what is Bayesian statistics, the impact of informative and non-informative priors, and clarifies when and why Bayesian approaches surpass frequentist analyses—especially in adaptive, platform, and rare disease trial settings. The discussion directly challenges the misconception that Bayesian methods “lower the bar," presenting evidence that they often require broader data synthesis and can raise evidentiary standards.

Key regulatory developments at FDA and EMA are reviewed, with attention to updated guidance and increased adoption. Case studies illustrate Bayesian methods in practice, including the prospectively combined phase 2 and 3 analysis for REBYOTA approval; hierarchical modeling in GNE myopathy; shared controls and endpoint integration in the HEALEY ALS Platform Trial; and robust subgroup borrowing in the ROAR basket trial. The team also addresses technical challenges such as multiplicity, subgroup analysis, complexity in endpoint modeling, and appropriate strategies for blending Bayesian and frequentist approaches for maximum regulatory and scientific clarity.

Key Highlights

  • Clear explanation and real-world examples of Bayesian analysis in clinical trials.
  • Theoretical and practical distinctions from frequentist methods
  • Practical breakdown of control sharing, endpoint integration, and subgroup borrowing.
  • Regulatory position and the increasing acceptance of Bayesian trial designs and analyses.
  • Case examples: REBYOTA, GNE myopathy, HEALY ALS Platform Trial, ROAR basket trial.
In the Interim...
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.