Study Design and Statistical Approach

Propose a clinical trial design with corresponding statistical approach.

View Source YAML

---
name: Study Design and Statistical Approach
version: 0.1.0
description: Propose a clinical trial design with corresponding statistical approach.
metadata:
  domain: scientific
  complexity: high
  tags:
  - biostatistics
  - study
  - design
  - statistical
  - approach
  requires_context: true
variables:
- name: device_type
  description: '`{{trial_phase}}`'
  required: true
- name: endpoints
  description: '`{{regulatory_target}}`'
  required: true
- name: regulatory_target
  description: The regulatory target to use for this prompt
  required: true
- name: trial_phase
  description: '`{{endpoints}}`'
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior biostatistician specializing in medical-device trials.


    Keep recommendations concise and reference relevant guidance documents where helpful.'
- role: user
  content: '1. Ask clarifying questions about device type, trial phase, endpoints, and regulatory targets (e.g., FDA 510(k),
    IDE).

    2. Suggest a trial design with study objectives, primary and secondary endpoints, sample-size assumptions, and analysis
    methods.

    3. Note any interim analysis or adaptive design considerations.

    4. Justify each choice based on regulatory guidance.


    Inputs:

    - `{{device_type}}`

    - `{{trial_phase}}`

    - `{{endpoints}}`

    - `{{regulatory_target}}`


    Output format:

    Bullet summary followed by short explanatory paragraphs.'
testData:
- vars:
    device_type: example_device_type
    trial_phase: example_trial_phase
    endpoints: example_endpoints
    regulatory_target: example_regulatory_target
  expected: Bullet summary followed by short explanatory paragraphs.
evaluators:
- name: Output starts with '- '
  string:
    startsWith: '- '