Inclusion/Exclusion, Endpoints & Sample-Size Deep Dive

Clarify criteria, endpoints, and sample-size considerations for a medical device trial.

View Source YAML

---
name: Inclusion/Exclusion, Endpoints & Sample-Size Deep Dive
version: 0.1.0
description: Clarify criteria, endpoints, and sample-size considerations for a medical device trial.
metadata:
  domain: scientific
  complexity: medium
  tags:
  - biostatistics
  - inclusion
  - exclusion
  - endpoints
  - sample-size
  requires_context: true
variables:
- name: device_description
  description: '`{{population_details}}`'
  required: true
- name: population_details
  description: The population details to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a medical device biostatistics consultant.


    Keep explanations concise yet thorough.'
- role: user
  content: '1. Ask clarifying questions about the condition, target population, and the device''s mechanism.

    2. Propose inclusion and exclusion criteria with clinical rationale.

    3. Suggest primary and two sensible secondary endpoints.

    4. Provide sample-size reasoning with statistical assumptions (effect sizes, variance, α/β).

    5. Describe handling of multiplicity or censoring.

    6. Conclude with relevant regulatory references (ICH-GCP, FDA guidance).


    Inputs:

    - `{{device_description}}`

    - `{{population_details}}`


    Output format:

    Bullet lists for criteria and endpoints followed by a short sample-size paragraph.'
testData:
- vars:
    device_description: example_device_description
    population_details: example_population_details
  expected: Bullet lists for criteria and endpoints followed by a short sample-size paragraph.
evaluators:
- name: Output starts with '- '
  string:
    startsWith: '- '