Tooluniverse Clinical Trial Design

This walks you through clinical trial feasibility by analyzing six dimensions: endpoint selection, patient population, comparator choice, effect size, trial duration, and regulatory pathway. It's built around precedent-based reasoning rather than theoretical calculations, pulling from prior trials, FDA guidance, and biomarker databases to generate enrollment projections and regulatory strategy. The output is a 14-section feasibility report with an evidence-graded recommendation system. Best for Phase 1/2 planning, biomarker-selected trials, or when you need to justify endpoint choices with actual regulatory precedent. It won't do first-principles statistical design, but it will tell you what's worked before and whether your patient population actually exists.

Install to Claude Code

npx -y skills add mims-harvard/tooluniverse --skill tooluniverse-clinical-trial-design --agent claude-code