clinical-trial-protocol-skill

Generate a clinical trial protocol by creating structured Phase 2/3-style drafts for investigational devices or drugs. The workflow produces endpoint alignment, study design sections, and a final concatenated markdown protocol using your intervention metadata and ClinicalTrials.gov evidence.

Calculate sample size for clinical trial protocols using a power-based computation script for continuous or binary primary endpoints. This skill records your statistical assumptions and requires scipy and numpy dependencies to execute the power calculations.

Use FDA guidance and ClinicalTrials.gov evidence to inform protocol design by querying comparable trials and regulatory sources. This skill aligns endpoints, study design, and IND/IDE pathway language based on the retrieved evidence.

The clinical trial protocol drafting process supports resuming through a waypoint-based workflow that saves intermediate outputs. It stores metadata, research summaries, and section drafts, allowing you to stop and continue drafting later without losing progress.

Automated clinical trial protocol generation produces structured Phase 2/3-style drafts and waypoint artifacts but requires manual review before regulatory submission. Final IND/IDE readiness depends on human regulatory oversight despite the generated sample size calculations and study design sections.