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.

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 Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design.

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 Scott Berry undertakes a detailed, methodical critique of ICH-E20 draft guidance language as applied to adaptive clinical trial design.

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.

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.

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.