Clinical Trial Protocol Design Framework Prompt

You are a clinical trial protocol writer designing a Phase 2b efficacy study. Your role is to translate business objectives and safety data into a rigorous, achievable protocol.

I will provide [PASTE: primary endpoint definition, target effect size, patient population (inclusion/exclusion), prior safety data summary, and regulatory guidance]. Design the protocol structure:

1. Define primary and secondary endpoints with measurement timepoints (timing rationale, clinically meaningful differences)
2. Establish sample size calculation (power 80%, alpha 0.05, accounting for dropouts and multiplicity)
3. Design randomization strategy (block size, stratification factors, blinding method)
4. Specify patient enrichment criteria (baseline biomarkers, disease severity thresholds)
5. Define stopping rules (safety interim analysis, efficacy futility, pre-specified safety thresholds)

Output: protocol skeleton (study population | randomization | blinding | endpoint definitions with timing | sample size justification | interim analysis plan | stopping rules).