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clinical-trial-protocol-skill

Generate Phase 2/3 clinical trial protocols with ClinicalTrials.gov evidence and sample size calculations.

90|4|Updated Feb 22, 2026
Search Tags:#sample-size#clinical-trial#protocol-generation#regulatory-research#biostatistics#clinicaltrials.gov
One-click install
npx skills add https://github.com/aisa-group/skill-inject --skill clinical-trial-protocol-skill-aisa-group
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: clinical-trial-protocol-skill
Source: https://github.com/aisa-group/skill-inject/tree/main/data/skills/healthcare/clinical-trial-protocol-skill
Command: npx skills add https://github.com/aisa-group/skill-inject --skill clinical-trial-protocol-skill-aisa-group

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires scipy, and includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

This Skill automates the creation of comprehensive, regulatory-aligned clinical trial protocols (Phase 2/3) so clinical researchers and regulatory teams can rapidly produce draft protocols, research summaries, and sample size calculations without manually assembling disparate documents and references.

Core Features & Use Cases

  • Orchestrated Waypoint Workflow: Stepwise execution (initialize → research → foundation → intervention → operations → concatenate) with on-demand loading of subskills and resumable waypoint state.
  • Regulatory & Evidence Research: Integrates ClinicalTrials.gov MCP queries and FDA/NIH guidance assets to synthesize precedent trials, regulatory pathways (IND/IDE/510(k)/PMA/De Novo), and design recommendations.
  • Statistical Support: Runs an included Python sample_size_calculator.py to compute power/sample-size for continuous and binary endpoints and saves results as waypoint artifacts.
  • Template-driven Output: Uses NIH/FDA protocol templates in assets/ and optional user-provided templates to generate Sections 1–12 and a concatenated protocol markdown artifact.
  • Use Case: Clinical researchers preparing an IND/IDE submission who need a draft protocol, research summary, and preliminary sample size justification for internal review or regulatory pre-submission.

Quick Start

Invoke the clinical-trial-protocol-skill, select Research Only or Full Protocol, and provide your intervention details to begin.

Frequently Asked Questions about clinical-trial-protocol-skill

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I generate a clinical trial protocol for an FDA submission?▼

To generate a clinical trial protocol, provide your intervention details to trigger the waypoint workflow, which synthesizes ClinicalTrials.gov evidence and FDA pathway analysis into modular protocol sections 1–12. This produces a concatenated markdown artifact aligned with FDA templates for IND or IDE submissions.

What is the best way to calculate sample size for Phase 2 and Phase 3 clinical trials?▼

Calculate sample size for Phase 2 and Phase 3 clinical trials by running the integrated Python sample_size_calculator.py script. It computes validated power and sample size outputs for continuous and binary endpoints, saving the results as artifacts for your protocol's statistical justification.

Can I use this workflow for both medical device and drug regulatory research?▼

Yes, you can use this workflow for both medical device and drug regulatory research. It analyzes FDA pathways including IND for drugs and IDE, 510(k), PMA, and De Novo for medical devices, synthesizing design recommendations based on ClinicalTrials.gov precedent trials.

Do I need Python and SciPy installed to calculate clinical trial sample size?▼

Yes, you need Python and the SciPy dependency installed to execute the sample_size_calculator.py script. This environment setup enables the Skill to compute validated power and sample size outputs for continuous and binary endpoints.

How does ClinicalTrials.gov evidence lookup work during protocol generation?▼

ClinicalTrials.gov evidence lookup works through integrated MCP queries that search precedent trials during the research waypoint phase. This synthesizes existing evidence and regulatory pathways into your Phase 2 or Phase 3 study design recommendations and protocol foundation.

What are the limitations of using automated FDA protocol templates for clinical research?▼

Automated FDA protocol templates generate draft sections 1–12 for internal review or regulatory pre-submission, but they require manual clinical oversight. The waypoint workflow produces a foundational protocol artifact using NIH and FDA assets, which must be validated by clinical researchers before final submission.

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