clinical-trial-protocol-skill — Claude Code skill: how to install
Builds clinical trial protocols for medical devices and drugs. It helps research prior studies and draft study sections for FDA submissions.
npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-code
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a claude-codeWhat clinical-trial-protocol-skill does
The skill uses a waypoint-driven workflow that writes intermediate files into waypoints/ as JSON and Markdown. Because progress is cached on disk, you can stop and resume generation at any time. It supports two execution paths: a research-only search through FDA records and similar studies, or an end-to-end authoring flow covering study design and operations.
Individual subskills from references/ load on demand. This keeps context usage low during long runs. For statistical power and group size estimation, the skill calls scripts/sample_size_calculator.py.
Execution relies on an external clinical trials MCP server alongside Python packages scipy >= 1.11.0 and numpy >= 1.24.0. Without the MCP server and these packages, study queries and power calculations fail.
What it helps with
- extract relevant clinical trials and FDA database precedents
- calculate statistical sample sizes for study groups
- draft structured trial protocol sections for an investigational device
- document operational schedules and participant eligibility rules
Example prompts for the agent
- Help me design a clinical study for a novel drug candidate
- Research similar trials and FDA guidance for pembrolizumab
- Create a clinical trial protocol draft for an investigational medical device
How to install clinical-trial-protocol-skill
1Skills CLI (Vercel)
npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-codenpx skills add anthropics/healthcare --skill clinical-trial-protocol -a claude-code2Manually: put the files in place
~/.claude/skills/clinical-trial-protocol/SKILL.mdCopy the whole skill folder; for one project use .claude/skills/clinical-trial-protocol/
1Skills CLI (Vercel)
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a codex2Manually: put the files in place
.agents/skills/clinical-trial-protocol/SKILL.mdFor all projects use ~/.agents/skills/
1Skills CLI (Vercel)
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a cursor2Manually: put the files in place
.cursor/skills/clinical-trial-protocol/SKILL.mdCursor also reads .agents/skills/ and .claude/skills/
1GitHub CLI
gh skill install anthropics/healthcare clinical-trial-protocol2Manually: put the files in place
.github/skills/clinical-trial-protocol/SKILL.md1Skills CLI (Vercel)
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a gemini-cli2Platform CLI
gemini skills install https://github.com/anthropics/healthcare --path plugins/healthcare/skills/clinical-trial-protocolManually: put the files in place
.devin/skills/clinical-trial-protocol/SKILL.mdThe legacy .windsurf/skills/ path still works
Skills CLI (Vercel)
npx skills add anthropics/healthcare --skill clinical-trial-protocol -a opencodeClaude.ai
Zip the folder and upload it in Settings → Capabilities → Skills
Step by step, with commands for each platform: How to install skills in Claude Code: five ways
Questions about clinical-trial-protocol-skill
How to install clinical-trial-protocol-skill in Claude Code?
Run npx skills add anthropics/healthcare --skill clinical-trial-protocol-skill -a claude-code in your terminal.
What does clinical-trial-protocol-skill do?
It guides trial design through step-by-step waypoints, querying clinical databases and compiling sections for medical device or drug study protocols.
What prerequisites does this skill require?
It requires a functioning clinical trials MCP server for study lookups, plus Python with scipy >= 1.11.0 and numpy >= 1.24.0 for sample size scripts.