With the ICH E20 draft guidance now released and entering the public comment stage, Dr.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.

This episode of "In the Interim..." features an in-depth discussion of the StrokeNet Thrombectomy Endovascular Platform (STEP), a multi-domain, adaptive platform trial for acute stroke, anchored in the NIH StrokeNet network.

Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial. Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test.

Berry Consultants is excited to announce the release of version 7.2 of FACTS (Fixed and Adaptive Clinical Trial Simulator) today, which now includes a broader set of dose escalation designs.

Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial. Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test.

Scott Berry convenes co-authors Kert Viele, Joe Marion, and Lindsay Berry to discuss the statistical and developmental nuances of inferentially seamless phase 2/3 clinical trial designs.