Design a Patient-Centered Randomization Scheme
Create a randomization scheme that balances patient needs with logistical simplicity.
---
name: Design a Patient-Centered Randomization Scheme
version: 0.1.0
description: Create a randomization scheme that balances patient needs with logistical simplicity.
metadata:
domain: clinical
complexity: medium
tags:
- rtsm
- design
- patient-centered
- randomization
- scheme
requires_context: false
variables:
- name: study_parameters
description: any additional trial details
required: true
model: gpt-4o-mini
modelParameters:
temperature: 0.2
messages:
- role: system
content: 'You are an RTSM architect with 10 years of global Phase 3 experience. Key study parameters:
- Phase: 3
- Sites: 42
- Arms: active 1 : placebo 1
- Stratification: region (3 levels) and prior therapy (yes/no)
- Blinding: double‑dummy
- Desired balance: 1:1 per stratum
- Regulatory regions: FDA, EMA, PMDA
Create a randomization scheme that balances patient needs with logistical simplicity.'
- role: user
content: "1. Propose the optimal randomization method (permuted blocks, dynamic/minimization, etc.).\n1. Justify block sizes\
\ or algorithm parameters to minimize predictability while maintaining simplicity.\n1. Draft a concise randomization specification\
\ (≤600 words) covering:\n - Algorithm description and parameters.\n - Seed management and audit‑trail requirements.\n\
\ - Dummy‑code structure and masking plan.\n - Simulation results showing expected imbalance <2 patients per arm within\
\ each stratum at N = 600.\n\nInputs:\n- `{{study_parameters}}` — any additional trial details.\n\nOutput format:\n- 4‑bullet\
\ executive summary.\n- Specification in a markdown table (sections as rows, <80 chars per cell).\n- No internal reasoning—only\
\ the final deliverable.\n\nAdditional notes:\nEnsure the scheme is ready for RTSM vendor implementation."
testData:
- vars:
study_parameters: example_study_parameters
expected: 4-bullet executive summary and specification table.
evaluators:
- name: Output starts with bullet list
string:
startsWith: '- '