A Goldilocks trial design is an adaptive clinical trial methodology developed to optimize the sample size dynamically during the course of a trial. Its name references the "just right" principle from the Goldilocks fairy tale—neither too large nor too small. Goldilocks designs seek balance between flexibility and efficiency.

A source of widespread confusion is the entrenched belief that introducing interim analyses “costs” alpha; that is, the assumption that interim adaptations erode the available alpha and require the sponsor to “pay a penalty.” This notion also leads to the myth that just the action of “looking at data” at an interim analysis is bad and costs alpha.

In this solo episode of "In the Interim...", Scott Berry, President and Senior Statistical Scientist at Berry Consultants, addresses deep-rooted confusion in the field of adaptive clinical trial design surrounding the concept of “spending alpha.”

Scott Berry, Founder of Berry Consultants, interviews Professor Craig Ritchie—specialist in brain health and neurodegenerative diseases, Chief Investigator of EPAD (European Prevention of Alzheimer Dementia), and CEO of Scottish Brain Sciences—for a precise analysis of platform trial methodology in Alzheimer’s research.

Regression-to-the-mean offers critical insights for drug development, like sports statistics, emphasizing the importance of understanding data variability across multiple levels of inference.

In this engaging episode of "In the Interim...", host Dr. Scott Berry is joined by Dr. Nick Berry to explore the intriguing parallels between sports and drug development, focusing on the concept of "regression-to-the-mean."