Clinical Trial Protocol

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 Codex Desktop
• Or configure manually in Codex 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

• EXECUTION CONTROL - READ THIS FIRST
• What This Skill Does
• Waypoint-Based Design (+2)
• How to Use
• Startup: Welcome and Mode Selection (+1)
• Intervention Overview
• Similar Clinical Trials
• FDA Regulatory Pathway
• FDA Guidance Documents
• Study Design Recommendations
• Key Insights and Recommendations
• Full Workflow Logic
• Waypoint File Formats (+2)
• MCP Server Unavailable (+2)
• Disclaimers
• Implementation Requirements