How does it handle statistical power and sample sizes?

The skill includes a built-in Python script using SciPy and NumPy to perform validated statistical calculations for study power and sample size requirements.

What happens if the protocol generation is interrupted?

The skill uses a waypoint-based design that saves progress to JSON files, allowing you to resume exactly where you left off without losing previous research or sections.

Where does the clinical trial research data come from?

The skill utilizes a clinical trials MCP server to search live registries and references official FDA databases for regulatory guidance and historical trial data.

Can this skill handle both drugs and medical devices?

Yes, the skill includes specialized logic and regulatory pathway research for both pharmaceutical drug interventions and various medical device classifications.

Clinical Trial Protocol Designer

Name: Clinical Trial Protocol Designer
Author: anthropics

byanthropics

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147

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Data Science & ML

Generates comprehensive clinical trial protocols for medical devices and drugs using a structured, research-driven automated workflow.

This skill automates the complex process of designing clinical trials by integrating real-time data from clinical trial registries and FDA databases. It employs a modular, waypoint-based architecture that guides users from initial intervention research and regulatory pathway identification through to statistical sample size calculations and the generation of NIH-standard protocol documentation. By leveraging specialized MCP servers and Python-based statistical scripts, it ensures that intervention designs are grounded in existing research and meet the rigorous requirements of regulatory submissions for investigational products.

Key Features

01147 GitHub stars

02Modular protocol generation for both pharmaceutical drugs and medical devices

03Automated FDA regulatory pathway research and guidance matching

04Persistent waypoint-based architecture to manage and resume complex workflows

05Validated statistical sample size and power analysis via integrated Python scripts

06Real-time clinical trial registry searching via MCP server integration

Use Cases

01Preparing FDA 510(k) or PMA submission documentation for novel medical devices

02Conducting comparative research on existing trials to optimize study endpoints and population criteria

03Designing a Phase II or III clinical study for a new therapeutic drug intervention

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add anthropics/life-sciences clinical-trial-protocol-skill

For use in Claude.ai and ChatGPT

Download Skill