With the ICH E20 Draft Guideline currently open for comments, Berry Consultants shares its current thoughts, general comments, and specific suggestions of the document in this blog.

Promising zone adaptive sample size designs appear compelling in theory, but all simulated and practical evidence demonstrates that group sequential trials outperform these methods in terms of efficiency and power for confirmatory trials.

Clinical trial simulation is the core engine for creating adaptive designs. This approach enables careful performance evaluation and iterative improvement of trial designs before a single patient enrolls. The result: more efficient, mathematically rigorous, and stakeholder-aligned clinical trials.

Bayesian statistics enables efficient, inclusive, and compliant clinical trial designs by rigorously updating evidence, supporting adaptation, and enabling comprehensive analysis across complex data landscapes.

The “time machine” enables rigorous, unbiased comparisons in adaptive platform trials by modeling era effects and overlapping treatments, improving resource allocation while ensuring accurate estimation.

With the ICH E20 draft guidance now released and entering the public comment stage, Dr. Kert Viele of Berry Consultants begins a new blog series on this topic. Dr. Viele provides explainers for the designs and principles under discussion, and some initial reactions to the draft ICH E20 related to Group Sequential Designs in this blog.