Tutorials | 7 min read | Beginner

How to Generate a Simon's Two-Stage Design in BioStatHub

A step-by-step tutorial for entering assumptions, generating candidate Simon's two-stage designs, selecting a final design, and exporting reports in BioStatHub.

Step 1: Define study assumptions

Start from the calculator and enter p0, p1, alpha, and beta. These inputs define the unacceptable response rate, target response rate, type I error limit, and type II error limit.

Choose a study priority when available so the recommendation aligns with the team's preference for minimizing expected enrollment, limiting maximum enrollment, or balancing tradeoffs.

Step 2: Review candidate designs

After generating designs, inspect the overview table and frontier chart. Compare the stage 1 rule, final rule, expected sample size, probability of early termination, type I error, and power.

Use the design details panel to understand why a candidate is recommended before setting the final design.

Step 3: Finalize and export

Once a final design is selected, move to the finalized protocol view. Review the stopping rule, final success rule, operating curves, and validation information.

Export the report or data files for protocol drafting, team review, or downstream documentation.