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Podcast Episode
59: Drug Development and Sports: The 10-Run Rule and Futility
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Nick Berry investigate how futility in clinical trials and stopping rules in sports illuminate very similar decision problems, albeit with very different consequences.
Blog
Regulatory Guidance, Adaptive Trials, and the Misconception of Efficiency
ICH-E20’s regulatory caution towards adaptive designs is often misapplied, resulting in inefficient or unrealistic alternatives for sponsors and patients. Operational casework demonstrates that so-called “complexity” in adaptive design is frequently misunderstood and that regulatory “false choices” undermine trial effectiveness.

Podcast Episode
58: ICH-E20, Regulators, and False Choices
In this episode of "In the Interim…", host Dr. Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design.

Podcast Episode
57: PANTHER: A Phase 2 International Platform Trial in ARDS
In this episode of "In the Interim…" Dr. Scott Berry is joined by Professors Victoria Cornelius, Danny McAuley, and Anthony Gordon, for a technical review of the PANTHER trial—an international, Phase 2 adaptive platform evaluating pharmacologic interventions for ARDS.

Podcast Episode
56: A Visit with Byron Gajewski: KUMC, Innovative Trial Designs, the HOBIT Trial
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.

Podcast Episode
55: A Visit with Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance
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.
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