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June 9, 2025
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Episode 16, “Spending Alpha"

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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.”

Dr. Scott Berry exposes a core misconception in adaptive trials on the latest episode of “In the Interim...”.

"Spending alpha" is the notion that interim analyses ‘cost’ alpha or impose a penalty. This is a statistical fallacy. Alpha is not lost by looking; it’s affected only when pre-specified actions at interims alter type I error.

Eliminate the 'penalty' label—it misrepresents the underlying mathematics and deters efficient design.

Key analytical findings from this episode:

● Merely observing interim data never mandates alpha adjustment.

● Only operational actions—such as early stopping for efficacy, dose selection, or carrying forward specific data—influence the trial’s type I error and necessitate alpha allocation.

● Distributed (not spent) alpha, when methodically applied, can achieve higher power, decrease failed trials, and reduce required sample size in specific adaptive configurations.

● Case evidence: Group sequential design, futility interim analysis, response-adaptive randomization, and the SEPSIS ACT trial—all confirm that efficiency comes from looking at data!

Persisting with misapplied terminology undermines scientific and operational progress.

For more insights listen to the full episode: https://www.berryconsultants.com/resource/16-spending-alpha

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