BioStatHub Knowledge Center

Educational articles about Simon's two-stage design, power functions, phase II trial design selection, sample size, early stopping, and BioStatHub workflows.

Articles

Fundamentals

10 min read | Beginner

How to Choose p₀ and p₁ in a Simon Two-Stage Design

A practical guide to selecting p₀ and p₁ for Simon two-stage designs, including the effect size concept, the four-way trade-off with α and β, and an iterative workflow for finding a feasible design.

10 min read | Beginner

How to Choose α and β in a Simon Two-Stage Design

A practical guide to choosing α and β in a Simon two-stage design, including their clinical interpretation, effect on sample size, common choices, and how to justify them in a Phase II protocol.

10 min read | Beginner

Why Phase II Clinical Trials Need Early Stopping

Explains why Phase II trials use prospective futility rules, how Simon’s two-stage design balances patient protection with statistical power, and how PET and ESS make the benefit visible.

Design Selection

10 min read | Intermediate

Optimal vs. Minimax Simon Designs: Which Should You Choose?

A practical guide to choosing between Simon's Optimal and Minimax two-stage designs by comparing expected sample size under p₀, early stopping, maximum enrollment, and the rationale behind each optimization objective.

Sample Size

8 min read | Intermediate

Expected Sample Size in Two-Stage Trials

Explains how expected sample size depends on the response probability, how it relates to probability of early termination, and how it can help compare Simon's two-stage designs.

Tutorials

Operating Characteristics