clinical-trial-protocol

Anthropic-published Claude Code plugin from the anthropics/healthcare marketplace. Drafts a full Phase 2/3 clinical-trial protocol document from a minimal indication / endpoint brief, following FDA and NIH templates.

   
Type Claude Code Plugin (Agent Skill)
Supplier Anthropic
Availability GA — shipped 2026-01 alongside the Claude for Healthcare launch
Pricing Free / OSS
Capabilities Read/Write — researches regulatory landscape, generates protocol document

How to install

  • Claude Code — plugin marketplace:

    /plugin marketplace add anthropics/healthcare
/plugin install clinical-trial-protocol@healthcare

  • Claude.ai — download the skill ZIP from the anthropics/healthcare repo and upload via Settings → Capabilities → Skills (Team / Enterprise admin).

What it does

A waypoint-based, four-step workflow that:

  1. Regulatory classification — searches FDA guidance documents to identify the relevant pathway (IND for drugs, IDE/IVD for devices).
  2. Competitive landscape — queries ClinicalTrials.gov for similar prior or active trials.
  3. Sample-size calculation — runs power calculations against the supplied endpoints and effect sizes.
  4. Protocol drafting — emits an initial full protocol document conforming to the FDA/NIH IND / IVD template.

Primary use cases: Early-stage protocol drafting at biotech and medical-device companies; regulatory-affairs first-drafts; medical-writing acceleration; trial-design exploration in academic labs.

Notes

Anthropic explicitly markets this as a sample / starting point — not production-ready. Review and adapt the SKILL.md and templates to your organization’s workflow before clinical use. Output is a draft for human review, not a submission-ready document.

Sources

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