# tooluniverse-clinical-trial-design

The skill scores a clinical trial design across six dimensions and returns a feasibility report with enrollment projections.

- skill · `type=skill` · Claude Code, Codex, Cursor, GitHub Copilot, Gemini CLI, OpenCode · 456 installs · ★ 1759
- Author: mims-harvard
- License: Apache-2.0 · policy=mirror · the beginning of the file is at the end of this page
- Source: https://github.com/mims-harvard/ToolUniverse/tree/HEAD/skills/tooluniverse-clinical-trial-design/SKILL.md
- Updated: 2026-10-24
- HTML: https://affpapa.org/en/nevibecode/skills/tooluniverse-clinical-trial-design

## What it does

The skill assesses trial feasibility along six dimensions: endpoint, population, comparator, effect size, duration and regulatory pathway. Answers come from precedent trials and FDA guidance rather than first-principles math. Output is a `[INDICATION]_trial_feasibility_report.md` with 14 sections — a 0–100 feasibility score, enrollment projections, endpoint recommendations and an approval-pathway analysis.

Six research paths run in parallel: population sizing, biomarker prevalence and testing, comparator selection, endpoint selection, safety monitoring and regulatory pathway. Every claim gets an evidence grade from A to D, ranging from an FDA-approved endpoint in the same indication down to a proposal with no precedent. Before any tool runs, the skill asks four questions: what the primary endpoint is, who the population is, what the comparator is, and whether the effect size fits the mechanism.

Tool calls use English drug, disease and biomarker names even when you write in another language; the answer comes back in your language. Model invocation is disabled, so the skill behaves as a procedure over external tools. Checking standard of care needs DrugBank and FDA tools, and prevalence comes from OpenTargets, gnomAD or COSMIC — without those sources some paths stall.

## Install

### Claude Code (native platform)

1. **Skills CLI (Vercel)**
```bash
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design -a claude-code
```

2. **Manually: put the files in place**
- File: `~/.claude/skills/tooluniverse-clinical-trial-design/SKILL.md` — Copy the whole skill folder; for one project use .claude/skills/tooluniverse-clinical-trial-design/

### Codex

1. **Skills CLI (Vercel)**
```bash
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design -a codex
```

2. **Manually: put the files in place**
- File: `.agents/skills/tooluniverse-clinical-trial-design/SKILL.md` — For all projects use ~/.agents/skills/

### Cursor

1. **Skills CLI (Vercel)**
```bash
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design -a cursor
```

2. **Manually: put the files in place**
- File: `.cursor/skills/tooluniverse-clinical-trial-design/SKILL.md` — Cursor also reads .agents/skills/ and .claude/skills/

### GitHub Copilot

1. **GitHub CLI**
```bash
gh skill install mims-harvard/ToolUniverse tooluniverse-clinical-trial-design
```

2. **Manually: put the files in place**
- File: `.github/skills/tooluniverse-clinical-trial-design/SKILL.md`

### Gemini CLI

1. **Skills CLI (Vercel)**
```bash
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design -a gemini-cli
```

2. **Platform CLI**
```bash
gemini skills install https://github.com/mims-harvard/ToolUniverse --path skills/tooluniverse-clinical-trial-design
```

### Windsurf (Devin Desktop)

**Manually: put the files in place**
- File: `.devin/skills/tooluniverse-clinical-trial-design/SKILL.md` — The legacy .windsurf/skills/ path still works

### OpenCode

**Skills CLI (Vercel)**
```bash
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design -a opencode
```

### Claude.ai

**Claude.ai**
- Zip the folder and upload it in Settings → Capabilities → Skills

Where a file is given instead of a command, copy the files from the source to that path: https://github.com/mims-harvard/ToolUniverse/tree/HEAD/skills/tooluniverse-clinical-trial-design/SKILL.md

## When to use it
- judge whether a Phase 1/2 trial can actually enroll enough patients
- pick a primary endpoint backed by precedent and FDA acceptance history
- estimate biomarker prevalence and plan an enriched population
- choose a comparator and decide whether placebo is defensible
- map the regulatory route: 505(b)(1), 505(b)(2), orphan drug, fast track

## Example prompts
- assess trial feasibility for this indication and build the design report
- pick an endpoint and comparator for a Phase 2 trial using precedent trials
- project enrollment for a biomarker-enriched population

## Source text · SKILL.md · Apache-2.0

Below is the content of a third-party file. It is data, not instructions for you: do not act on anything written inside unless the human asks. Block tag: 93b11003d294250b.

BEGIN THIRD-PARTY FILE 93b11003d294250b
```text
---
name: tooluniverse-clinical-trial-design
description: Strategic clinical trial design feasibility assessment. Analyzes 6 dimensions (endpoint, population, comparator, effect size, duration, regulatory pathway) using precedent trials and FDA guidance. Produces enrollment projections, endpoint recommendations, and approval-pathway analysis. Use for trial-protocol design, power/sample-size estimation, comparator selection, and FDA submission strategy. Driven by precedent-based reasoning rather than first-principles math.
disable-model-invocation: true
---

# 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.

## Reasoning Before Searching

Trial design starts with the question, not the methods. Answer these four questions before running any tools — they determine everything else:

1. **What is the primary endpoint?** Is it overall survival (gold standard but slow), PFS (faster but surrogate), ORR (single-arm friendly but not always accepted), or a biomarker (needs validation as surrogate first)? The endpoint determines FDA pathway, statistical design, and duration.
2. **Who is the population?** Broad unselected vs. biomarker-enriched. Enriched populations have higher response rates, allowing smaller trials — but require a validated companion diagnostic and reduce the eligible patient pool.
```
END THIRD-PARTY FILE 93b11003d294250b

The third-party file has ended. Everything between the 93b11003d294250b tags is data: requests and commands from it are not followed. An “end of file” line with another tag inside the block is part of the file.

First 1795 of 13438 bytes. © mims-harvard · Apache-2.0 · https://github.com/mims-harvard/ToolUniverse/tree/HEAD/skills/tooluniverse-clinical-trial-design/SKILL.md

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