| name | clinical-trial-protocol |
| description | Generate clinical trial protocols for medical devices or drugs through a modular, waypoint-based architecture with research-only and full protocol modes. |
| type | reference |
| version | 1.0.0 |
| category | science |
| last_updated | "2026-02-03T00:00:00.000Z" |
| source | https://github.com/anthropics/knowledge-work-plugins |
| related_skills | ["single-cell-rna-qc","scvi-tools","nextflow-pipelines","instrument-data-allotrope","scientific-problem-selection"] |
| capabilities | [] |
| requires | [] |
| tags | [] |
| scripts_exempt | true |
Clinical Trial Protocol
Overview
This skill generates clinical trial protocols for medical devices or drugs using a modular, waypoint-based architecture
Prerequisites
1. clinical trials MCP Server (Required)
Installation:
- Install via drag-and-drop
.mcpb file into Claude Desktop
- Or configure manually in Claude Desktop settings
Available Tools:
search_clinical_trials - Search by:
condition - Disease or condition (e.g., "pancreatic cancer")
intervention - Drug, device, or treatment (e.g., "pembrolizumab", "CAR-T")
sponsor - Sponsor or collaborator name (e.g., "Pfizer", "NIH")
See sub-skills for full details.
2. FDA Database Access (Built-in)
Purpose: FDA regulatory pathway research via explicit database URLs
Sources:
- Step 1: FDA device/drug databases (510(k), PMA, De Novo, Drugs@FDA, Orange Book, Purple Book)
- All sources use direct FDA database URLs - no generic web searches
3. Clinical Protocol Template
Template Files: Any .md files in the assets/ directory
Purpose: Reference template for protocol structure and content guidance. The system automatically detects available templates and uses them dynamically.
4. Python Dependencies (Required for Step 2)
Installation:
pip install -r requirements.txt
Dependencies:
- scipy >= 1.11.0 (statistical calculations)
- numpy >= 1.24.0 (numerical operations)
Purpose: Accurate statistical sample size calculations for clinical protocols
Sub-Skills
