News and Events
June 23, 2025
No items found.

Episode 17, “Seamless 2/3 Trial Designs"

Play video
No items found.
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.

In episode 17 of “In the Interim...”, Scott Berry is joined by his colleagues, Kert Viele, Joe Marion, and Lindsay Berry to discuss the paper "Optimal Sample Size Division in Two-Stage Seamless Designs," recently published in Pharmaceutical Statistics.

Key Points:

• A simple closed-form alpha adjustment replaces awkward, somewhat inaccessible closed testing procedures.

• Including stage 1 data yields higher statistical power; in every scenario, this approach outperforms separate analyses.

• When designing seamless 2/3 trials, it is optimal to allocate more patients to the phase 2 part improving dose-selection while increasing power.

• Available R code in the supplement enables straightforward calculation of final analysis thresholds.

By integrating the learn and confirm of clinical trials you can do both better – you will learn better and confirm better employing inferentially seamless trial designs.

For more insights, listen to today's full episode at: https://www.berryconsultants.com/resource/17-seamless-2-3-trial-designs

Download PDF
View