Seamless adaptive trials can deliver higher statistical power with fewer patients and shorter timelines, yet practical funding hurdles persist. Objective administrative (financial) analyses—often Bayesian-driven—can define funding triggers without compromising trial integrity.

Digital twins in clinical research generate discussion and controversy, but current use is limited by lack of rich data sets. The potential is great for modeling counterfactual outcomes in clinical research, and we will get there.

Novel clinical trial designs are often subject to heightened scrutiny for statistical risks that persist in standard methods, revealing inconsistencies in regulatory and scientific expectations. When evaluation of a novel design is done there are hurdles or criticism of the novel approach that already exist with the standard approach and many times are higher risk than in the novel approach.

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.