clinical-trial-protocol-skill

The clinical-trial-protocol-skill is an advanced orchestrator designed for clinical researchers, regulatory affairs professionals, and protocol writers. It facilitates the end-to-end development of clinical trial protocols for medical devices and pharmaceutical products by following a structured, waypoint-based workflow. This tool streamlines the transition from initial concept to a professional, ready-for-review protocol document, significantly reducing the administrative burden of documentation while maintaining adherence to clinical research best practices.

The skill provides two primary operational modes: a Research Only Mode for gathering background data, and a Full Protocol Mode that guides users through every step of the drafting process—from initial intervention setup to operational statistics and final documentation. By leveraging a modular architecture, the skill allows users to resume interrupted workflows and ensures that critical metadata is preserved throughout the process.

• Automatically searches ClinicalTrials.gov and parses FDA guidance documents to inform study design.

• Features a built-in statistical power analysis tool utilizing Python and SciPy for calculating sample sizes for both superiority and non-inferiority trials.

• Implements a waypoint-based design that generates modular artifacts, including intervention metadata, research summaries, and detailed protocol sections.

• Supports integration with external MCP servers for extended data retrieval and analysis capabilities.

• Users should expect to provide input regarding the intervention type (device/drug), disease condition, trial phase, and study population.

• The tool requires Python dependencies (scipy, numpy) for accurate statistical calculations.

• Protocol output is generated in structured Markdown, suitable for further refinement or export to document processors.

• Disclaimer: This tool serves as a foundational drafting aid and is not a substitute for formal biostatistician review, legal counsel, or regulatory approval from organizations like the FDA. All protocols must undergo rigorous professional validation and IRB review before clinical implementation.