The FDA Draft Bayesian guidance is a dramatic leap forward for Bayesian clinical trials and regulatory science. In this blog, Dr. Kert Viele outlines the key concepts and motivations for the guidance recommendations.

In recent public discussion, FDA leaders have indicated a possible shift from the longstanding two-trial requirement for substantial evidence of drug efficacy to acceptance of a single, highly stringent trial. Dr. Scott Berry and Dr. Kert Viele, on the "In the Interim..." podcast, analyze the statistical, regulatory, and scientific implications and highlight those in this blog.

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.