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clinical-study-designer

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Clinical study design skill for medical device trials including IDE studies and post-market studies

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How to use this skill

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Source SKILL.md: https://github.com/a5c-ai/babysitter/blob/HEAD/library/specializations/domains/science/biomedical-engineering/skills/clinical-study-designer/SKILL.md

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Clinical Study Designer Skill

Purpose

The Clinical Study Designer Skill supports design of clinical studies for medical devices, including IDE studies, post-market studies, and registries, ensuring scientific rigor and regulatory acceptance.

Capabilities

  • Study design selection (RCT, single-arm, registry)
  • Endpoint definition guidance
  • Sample size calculation (superiority, non-inferiority, equivalence)
  • Protocol template generation
  • Informed consent template generation
  • CRF design assistance
  • Statistical analysis plan development
  • Randomization strategy
  • Blinding methodology
  • Interim analysis planning
  • Adaptive design support

Usage Guidelines

When to Use

  • Designing clinical trials
  • Calculating sample sizes
  • Developing protocols
  • Planning statistical analyses

Prerequisites

  • Clinical objectives defined
  • Target population identified
  • Comparator strategy determined
  • Regulatory pathway established

Best Practices

  • Select design appropriate for objectives
  • Ensure adequate statistical power
  • Plan for missing data
  • Include clinically meaningful endpoints

Process Integration

This skill integrates with the following processes:

  • Clinical Study Design and Execution
  • Clinical Evaluation Report Development
  • AI/ML Medical Device Development
  • Post-Market Surveillance System Implementation

Dependencies

  • PASS software
  • nQuery
  • FDA IDE guidance
  • ISO 14155 standard
  • Statistical analysis tools

Configuration

clinical-study-designer:
  study-designs:
    - randomized-controlled
    - single-arm
    - crossover
    - registry
    - real-world-evidence
  hypothesis-types:
    - superiority
    - non-inferiority
    - equivalence
  endpoint-types:
    - primary
    - secondary
    - exploratory

Output Artifacts

  • Protocol documents
  • Statistical analysis plans
  • Sample size calculations
  • Informed consent templates
  • CRF designs
  • Randomization schemes
  • Study synopses
  • IDE submission components

Quality Criteria

  • Design appropriate for clinical question
  • Sample size adequately powered
  • Endpoints clinically meaningful
  • Protocol comprehensive
  • SAP statistically rigorous
  • Documentation supports regulatory acceptance