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Individual AI skill · AI for Biomedical Research

clinical-trial-protocol-skill

Genera protocolos de ensayos clinicos para dispositivos medicos o farmacos. Incluye diseno de estudios, seleccion de pacientes y metodologias.

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1Name the real task

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2Provide the evidence

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3Define done

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Adaptable starting prompt Replace the brackets with your case

What you need first

1. clinical trials MCP Server (Required)

Installation:

  • Install via drag-and-drop .mcpb file into Claude Desktop
  • Or configure manually in Claude Desktop settings

Available Tools: search_clinical_trials - Search by:

condition - Disease or condition (e.g., "pancreatic cancer") intervention - Drug, device, or treatment (e.g., "pembrolizumab", "CAR-T") sponsor - Sponsor or collaborator name (e.g., "Pfizer", "NIH") location - City, state, or country (e.g., "California", "Boston") status - "recruiting" (default), "active", "completed", "all" phase - Trial phase: "1", "2", "3", "4", "early_phase1" max_results - Default 25, max 100

get_trial_details - Get comprehensive details for a specific trial using its nct_id (e.g., "NCT04267848"). Returns eligibility criteria, outcomes, study design, and contact information.

Verification: Step 1 will automatically test MCP connectivity at startup.

2. FDA Database Access (Built-in)

Purpose: FDA regulatory pathway research via explicit database URLs

Sources:

  • Step 1: FDA device/drug databases (510(k), PMA, De Novo, Drugs@FDA, Orange Book, Purple Book)
  • All sources use direct FDA database URLs - no generic web searches

3. Clinical Protocol Template

Template Files: Any .md files in the assets/ directory

Purpose: Reference template for protocol structure and content guidance. The system automatically detects available templates and uses them dynamically.

4. Python Dependencies (Required for Step 2)

Installation:

pip install -r requirements.txt

Dependencies:

  • scipy >= 1.11.0 (statistical calculations)
  • numpy >= 1.24.0 (numerical operations)

Purpose: Accurate statistical sample size calculations for clinical protocols

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AI for Biomedical Research

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skills/verticals/biomedical-research/skills/clinical-trial-protocol-skill
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