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.

skills.sh installs: 458
GitHub stars: 1.8K
last updated: Aug 21, 2026

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Install

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

Installs into .claude/skills of the current project.

Files

Clinical Trial Design Feasibility Assessment

Systematically assess clinical trial feasibility by analyzing 6 research dimensions. Produces comprehensive feasibility reports with quantitative enrollment projections, endpoint recommendations, and regulatory pathway analysis.

IMPORTANT: Always use English terms in tool calls (drug names, disease names, biomarker names), even if the user writes in another language. Only try original-language terms as a fallback if English returns no results. Respond in the user's language.