clinical-trial-protocol-skill

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.